Table Of Content

The data in this document is reported as of Monday, September 28, 2015 Approved American National Standards User Guide for American National Standards (ANS) related Data Listed below are approved American National Standards (ANS) as of 9/28/2015. Additional information about these ANS has been published in ANSI’s Standards Action during the standards development cycle as indicated by the PINS Date and/or Public Review Start Date and Approval Date. To review this additional information, archived issues of ANSI's Standards Action in (PDF) format are available at (www.ansi.org/standardsaction). Questions concerning a particular ANS should be directed to the sponsoring ANSI-Accredited Standards Developer (ASD). Some ANS are available for purchase at http://webstore.ansi.org/. Information about proposed ANS is available in a separate document at www.ansi.org/proposedANSprojects . The procedures that govern the ANS process are called the “ANSI Essential Requirements: Due process requirements for American National Standards” www.ansi.org/essentialrequirements. A list of all ASDs is available at www.ansi.org/asd. Questions concerning the ANS process may be directed to [email protected]. Thank you for your interest. ANSI H35.5-2013,Standard Nomenclature System for Aluminum Metal 3-A (3-A Sanitary Standards, Inc. ) Matrix Composite Materials (revision of ANSI H35.5-1993 (R2009)) www.3-a.org PINS Date: Aug 17, 2012 Public Review Start: May 31, 2013 Approval Date: Nov 7, 2013 ANSI/3-A 00-00-2014,3-A® Sanitary Standards for General Requirements (new standard) PINS Date: Jan 27, 2012 AAMI (Association for the Advancement of Medical Public Review Start: May 23, 2014 Instrumentation ) Approval Date: Sep 8, 2014 www.aami.org ANSI/AAM/IEC 60601-1-2-2014,Medical electrical equipment - Part 1 AA (ASC H35) (Aluminum Association ) -2: General requirements for basic safety and essential performance - www.aluminum.org Collateral standard: Electromagnetic disturbances - Requirements and tests (identical national adoption of IEC 60601-1-2 and revision of ANSI/AAMI/IEC 60601-1-2, Ed.2-2007 (R2012)) ANSI H35.1/H35.1(M)-2013,Standard Alloy and Temper Designation PINS Date: Systems for Aluminum (revision of ANSI H35.1/H35.1(M)-2009) Public Review Start: Aug 17, 2012 PINS Date: Aug 17, 2012 Approval Date: May 8, 2014 Public Review Start: May 31, 2013 Approval Date: Nov 7, 2013 ANSI/AAMI 11663-2014,Quality of dialysis fluid for haemodialysis and related therapies (national adoption of ISO 11663:2014 with ANSI H35.2-2013,Standard Dimensional Tolerances for Aluminum Mill modifications and revision of ANSI/AAMI/ISO 11663-2009 (Ed1)) Products (revision of ANSI H35.2-2009) PINS Date: Feb 8, 2013 PINS Date: Aug 17, 2012 Public Review Start: Feb 7, 2014 Public Review Start: May 31, 2013 Approval Date: Aug 8, 2014 Approval Date: Nov 7, 2013 ANSI/AAMI 13958-2014,Concentrates for haemodialysis and related ANSI H35.2(M)-2013,Standard Dimensional Tolerances for Aluminum therapies (national adoption of ISO 13958:2014 with modifications and Mill Products (revision of ANSI H35.2(M)-2009) revision of ANSI/AAMI/ISO 13958-2009) PINS Date: Aug 17, 2012 PINS Date: Feb 8, 2013 Public Review Start: May 31, 2013 Public Review Start: Feb 14, 2014 Approval Date: Nov 7, 2013 Approval Date: Aug 15, 2014 ANSI H35.3-1997 (R2013),Standard Designation System for Aluminum ANSI/AAMI 13959-2014,Water for haemodialysis and related therapies Hardeners (reaffirmation of ANSI H35.3-1997 (R2009)) (national adoption of ISO 13959:2014 with modifications and revision PINS Date: Aug 17, 2012 of ANSI/AAMI/ISO 13959-2009) Public Review Start: May 31, 2013 PINS Date: Feb 8, 2013 Approval Date: Nov 7, 2013 Public Review Start: Feb 14, 2014 Approval Date: Aug 15, 2014 ANSI H35.4-2006 (R2013),Standard Designation System for Unalloyed Aluminum (reaffirmation of ANSI H35.4-2006 (R2009)) ANSI/AAMI 23500-2014,Guidance for the preparation and quality PINS Date: Aug 17, 2012 management of fluids for haemodialysis and related therapies Public Review Start: May 31, 2013 (national adoption of ISO 23500:2014 with modifications and revision Approval Date: Nov 7, 2013 of ANSI/AAMI/ISO 23500-2011) PINS Date: Feb 8, 2013 Public Review Start: Feb 14, 2014 Approval Date: Aug 15, 2014 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 0 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI 26722-2014,Water treatment equipment for haemodialysis ANSI/AAMI EC71-2001 (R2013),Standard communications protocol - applications and related therapies (national adoption of ISO Computer assisted electrocardiography (reaffirmation of ANSI/AAMI 26722:2014 with modifications and revision of ANSI/AAMI/ISO 26722 EC71-2001 (R2007)) -2009) PINS Date: PINS Date: Feb 8, 2013 Public Review Start: Nov 2, 2012 Public Review Start: Feb 14, 2014 Approval Date: Sep 19, 2013 Approval Date: Aug 8, 2014 ANSI/AAMI EQ56-2013,Recommended practice for a medical ANSI/AAMI AT6-2013,Autologous transfusion devices (revision of equipment management program (revision of ANSI/AAMI EQ56-1999 ANSI/AAMI AT6-2005 (R2011)) (R2008)) PINS Date: PINS Date: Feb 25, 2011 Public Review Start: Feb 15, 2013 Public Review Start: Jul 27, 2012 Approval Date: Aug 27, 2013 Approval Date: Mar 13, 2013 ANSI/AAMI BE83-2006 (R2011),Biological evaluation of medical ANSI/AAMI EQ89-2015,Guidance for the use of medical equipment devices - Part 18: Chemical characterization of materials (reaffirmation maintenance strategies and procedures (new standard) of ANSI/AAMI BE83-2006) PINS Date: Aug 3, 2012 PINS Date: Public Review Start: Jul 25, 2014 Public Review Start: Aug 12, 2011 Approval Date: Feb 12, 2015 Approval Date: Dec 2, 2011 ANSI/AAMI ES60601-1-2005 C1-2009 and A2 (R2012),Medical ANSI/AAMI BF64-2012,Leukocyte reduction filters (revision of electrical equipment - Part 1: General requirements for basic safety and ANSI/AAMI BF64-2002 (R2011)) essential performance (reaffirmation of ANSI/AAMI ES60601-1-2005) PINS Date: Mar 30, 2012 PINS Date: Public Review Start: Apr 13, 2012 Public Review Start: Oct 14, 2011 Approval Date: Nov 29, 2012 Approval Date: Jan 17, 2012 ANSI/AAMI BF7-2012,Blood transfusion microfilters (revision of ANSI/AAMI ES60601-1-2005, A1-2012,Medical electrical equipment - ANSI/AAMI BF7-1989 (R2011)) Part 1: General requirements for basic safety and essential PINS Date: Mar 30, 2012 performance Amendment 1 (supplement to ANSI/AAMI ES60601-1 Public Review Start: Apr 27, 2012 -2005) Approval Date: Nov 30, 2012 PINS Date: Public Review Start: Apr 22, 2011 Approval Date: Aug 21, 2012 ANSI/AAMI BP22-1994 (R2011),Blood pressure transducers (reaffirmation of ANSI/AAMI BP22-1994 (R2006)) PINS Date: ANSI/AAMI HA60601-1-11-2015,Medical electrical equipment - Part 1 Public Review Start: Sep 23, 2011 -11: General requirements for basic safety and essential performance - Approval Date: Dec 14, 2011 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (national adoption of IEC 60601-1-11:2015 with modifications and ANSI/AAMI EC12-2000 (R2010),Disposable ECG electrodes revision of ANSI/AAMI HA60601-1-11-2011) (reaffirmation of ANSI/AAMI EC12-2000 (R2005)) PINS Date: Nov 8, 2013 PINS Date: Public Review Start: Mar 27, 2015 Public Review Start: Jan 22, 2010 Approval Date: Aug 25, 2015 Approval Date: Aug 24, 2010 ANSI/AAMI HE75-2009 (R2013),Human factors engineering - Design of ANSI/AAMI EC53-2013,ECG trunk cables and patient leadwires medical devices (reaffirmation of ANSI/AAMI HE75-2009) (revision, redesignation and consolidation of ANSI/AAMI EC53-1995 PINS Date: (R2008) and ANSI/AAMI EC53/A1-1998 (R2008)) Public Review Start: Jul 12, 2013 PINS Date: Mar 13, 2009 Approval Date: Nov 26, 2013 Public Review Start: Jun 3, 2011 Approval Date: Nov 19, 2013 ANSI/AAMI ID26-2004 (R2013),Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers ANSI/AAMI EC57-2012,Testing and reporting performance results of (reaffirmation of ANSI/AAMI ID26-2004 (R2009)) cardiac rhythm and ST segment measurement algorithms (revision of PINS Date: ANSI/AAMI EC57-1998 (R2008)) Public Review Start: Aug 16, 2013 PINS Date: Mar 13, 2009 Approval Date: Nov 26, 2013 Public Review Start: Jun 3, 2011 Approval Date: Dec 18, 2012 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 1 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI ID54-1996 (R2012),Enteral feeding set adapters and ANSI/AAMI ST15883-3-2012 (ISO 15883-3-2006)MOD,Washer- connectors (reaffirmation of ANSI/AAMI ID54-1996 (R2005)) disinfectors - Part 3: Requirements and tests for washer-disinfectors PINS Date: employing thermal disinfection for human waste containers (national Public Review Start: May 20, 2011 adoption with modifications of ISO 15883-3:2006) Approval Date: Jan 17, 2012 PINS Date: May 19, 2006 Public Review Start: Aug 31, 2012 Approval Date: Dec 10, 2012 ANSI/AAMI NS28-1988 (R2015),Intracranial pressure monitoring devices (reaffirmation of ANSI/AAMI NS28-1988 (R2010)) PINS Date: ANSI/AAMI ST24-1999 (R2013),Automatic, general-purpose ethylene Public Review Start: Apr 17, 2015 oxide sterilizers and ethylene oxide sterilant sources intended for use in Approval Date: Aug 31, 2015 health care facilities (reaffirmation of ANSI/AAMI ST24-1999 (R2009)) PINS Date: Public Review Start: Aug 16, 2013 ANSI/AAMI NS4-2013,Transcutaneous electrical stimulators (new Approval Date: Nov 26, 2013 standard) PINS Date: Aug 10, 2012 Public Review Start: Sep 21, 2012 ANSI/AAMI ST40-2004 (R2010),Table-top dry heat (heated air) Approval Date: Mar 20, 2013 sterilization and sterility assurance in health care facilities (reaffirmation of ANSI/AAMI ST40-2004) PINS Date: ANSI/AAMI PB70-2012,Liquid barrier performance and classification of Public Review Start: Dec 18, 2009 protective apparel and drapes intended for use in health care facilities Approval Date: Mar 24, 2010 (revision of ANSI/AAMI PB70-2003 (R2009)) PINS Date: Jan 23, 2009 Public Review Start: Jul 1, 2011 ANSI/AAMI ST41-2008 (R2012),Ethylene oxide sterilization in health Approval Date: Jun 21, 2012 care facilities: Safety and effectiveness (reaffirmation of ANSI/AAMI ST41-2008) PINS Date: ANSI/AAMI RD47-2008 (R2013),Reprocessing of hemodialyzers Public Review Start: Aug 10, 2012 (reaffirmation of ANSI/AAMI RD47-2008) Approval Date: Nov 29, 2012 PINS Date: Public Review Start: May 10, 2013 Approval Date: Oct 4, 2013 ANSI/AAMI ST50-2004 (R2010),Dry heat (heated air) sterilizers (reaffirmation of ANSI/AAMI ST50-2004) PINS Date: ANSI/AAMI ST15883-1-2009/A1-2014,Washer-disinfectors - Part 1: Public Review Start: Dec 18, 2009 General requirements, terms and definitions and tests - Amendment 1 Approval Date: Mar 24, 2010 (identical national adoption of ISO 15883-1:2006/DAmd 1) PINS Date: Sep 23, 2011 Public Review Start: May 25, 2012 ANSI/AAMI ST55-2010 (R2014),Table-top steam sterilizers Approval Date: Jul 17, 2014 (reaffirmation of ANSI/AAMI ST55-2010) PINS Date: Public Review Start: Feb 14, 2014 ANSI/AAMI ST15883-1-2009/A2-2012,Washer-disinfectors - Part 1: Approval Date: Sep 19, 2014 General requirements, terms and definitions and tests, Amendment 2 (supplement to ANSI/AAMI ST15883-1-2009) PINS Date: Oct 28, 2011 ANSI/AAMI ST58-2013,Chemical sterilization and high-level Public Review Start: Dec 23, 2011 disinfection in health care facilities (revision of ANSI/AAMI ST58-2005 Approval Date: Aug 23, 2012 (R2010)) PINS Date: Sep 10, 2010 Public Review Start: Oct 5, 2012 ANSI/AAMI ST15883-2-2013 (ISO 15883-2-2006 MOD),Washer- Approval Date: Aug 21, 2013 disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc (national ANSI/AAMI ST65-2008 (R2013),Processing of reusable surgical textiles adoption with modifications of ISO 15883-2:2006) for use in health care facilities (reaffirmation of ANSI/AAMI ST65-2008) PINS Date: May 19, 2006 PINS Date: Public Review Start: Aug 31, 2012 Public Review Start: Aug 16, 2013 Approval Date: Jan 9, 2013 Approval Date: Dec 2, 2013 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 2 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI ST67-2011,Sterilization of health care products - ANSI/AAMI ST79-2010/A3.1-2012,Comprehensive guide to steam Requirements and guidance for selecting a sterility assurance level sterilization and sterility assurance in health care facilities (addenda to (SAL) for products labeled "sterile" (revision of ANSI/AAMI ST67-2003 ANSI/AAMI ST79-2010) (R2008)) PINS Date: Feb 17, 2012 PINS Date: Jan 23, 2009 Public Review Start: Mar 9, 2012 Public Review Start: Sep 17, 2010 Approval Date: Aug 22, 2012 Approval Date: Apr 11, 2011 ANSI/AAMI ST79-2010/A3.2-2012,Comprehensive guide to steam ANSI/AAMI ST72-2011,Bacterial endotoxin -Test methods, routine sterilization and sterility assurance in health care facilities (addenda to monitoring and alternatives to batch testing (revision of ANSI/AAMI ANSI/AAMI ST79-2010) ST72-2002 (R2010)) PINS Date: Feb 17, 2012 PINS Date: Jan 23, 2009 Public Review Start: Mar 9, 2012 Public Review Start: Mar 11, 2011 Approval Date: Aug 23, 2012 Approval Date: Dec 19, 2011 ANSI/AAMI ST79-2010/A3.3-2012,Comprehensive guide to steam ANSI/AAMI ST77-2013,Containment devices for reusable medical sterilization and sterility assurance in health care facilities (addenda to device sterilization (revision of ANSI/AAMI ST77-2006 (R2010)) ANSI/AAMI ST79-2010) PINS Date: Dec 24, 2010 PINS Date: Feb 17, 2012 Public Review Start: Jul 13, 2012 Public Review Start: Mar 9, 2012 Approval Date: Feb 1, 2013 Approval Date: Aug 23, 2012 ANSI/AAMI ST79-2010 (R2014),Comprehensive guide to steam ANSI/AAMI ST79-2010/A3.4-2012,Comprehensive guide to steam sterilization and sterility assurance in health care facilities sterilization and sterility assurance in health care facilities (addenda to (reaffirmation of ANSI/AAMI ST79-2010, A1:2010, A2:2011, A3:2012, ANSI/AAMI ST79-2010) A4:2013) PINS Date: Feb 17, 2012 PINS Date: Public Review Start: Mar 9, 2012 Public Review Start: Feb 14, 2014 Approval Date: Aug 23, 2012 Approval Date: Sep 23, 2014 ANSI/AAMI ST79-2010/A3.5-2012,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.1-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012 PINS Date: Feb 25, 2011 Public Review Start: Mar 9, 2012 Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012 Approval Date: Aug 8, 2011 ANSI/AAMI ST79-2010/A3.6-2012,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.2-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012 PINS Date: Feb 25, 2011 Public Review Start: Mar 16, 2012 Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012 Approval Date: Aug 8, 2011 ANSI/AAMI ST79-2010/A3.7-2012,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.3-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012 PINS Date: Feb 25, 2011 Public Review Start: Mar 16, 2012 Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012 Approval Date: Aug 8, 2011 ANSI/AAMI ST79-2010/A4.1-2013,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.5-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Jan 18, 2013 PINS Date: Feb 25, 2011 Public Review Start: Feb 22, 2013 Public Review Start: Apr 1, 2011 Approval Date: Oct 14, 2013 Approval Date: Sep 19, 2011 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 3 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI ST79-2010/A4.2-2013,Comprehensive guide to steam ANSI/AAMI/IEC 60601-2-2-2009 (R2014),Medical electrical equipment sterilization and sterility assurance in health care facilities (addenda to - Part 2-2: Particular requirements for the basic safety and essential ANSI/AAMI ST79-2010) performance of high frequency surgical equipment and high frequency PINS Date: Jan 18, 2013 surgical accessories (reaffirmation of ANSI/AAMI/IEC 60601-2-2-2009) Public Review Start: Jun 28, 2013 PINS Date: Approval Date: Oct 14, 2013 Public Review Start: Apr 18, 2014 Approval Date: Dec 10, 2014 ANSI/AAMI ST8-2013,Hospital steam sterilizers (revision of ANSI/AAMI ST8-2008) ANSI/AAMI/IEC 60601-2-20-2009,Medical electrical equipment - Part 2 PINS Date: Aug 19, 2011 -20: Particular requirements for basic safety and essential performance Public Review Start: Aug 31, 2012 of transport incubators (identical national adoption of IEC 60601-2-20 Approval Date: Apr 25, 2013 and revision of ANSI/AAMI II51-2004) PINS Date: Oct 20, 2006 Public Review Start: Jul 6, 2007 ANSI/AAMI ST81-2004 (R2010),Sterilization of medical devices - Approval Date: Apr 3, 2009 Information to be provided by the manufacturer for the processing of resterilizable medical devices (reaffirmation of ANSI/AAMI ST81-2004) PINS Date: ANSI/AAMI/IEC 60601-2-20-2009 (R2014),Medical electrical Public Review Start: Dec 18, 2009 equipment - Part 2-20: Particular requirements for the basic safety and Approval Date: Mar 24, 2010 essential performance of infant transport incubators (reaffirmation of ANSI/AAMI/IEC 60601-2-20-2009) PINS Date: ANSI/AAMI ST91-2015,Flexible and semi-rigid endoscope reprocessing Public Review Start: Apr 18, 2014 in health care facilities (new standard) Approval Date: Dec 10, 2014 PINS Date: May 16, 2014 Public Review Start: Aug 1, 2014 Approval Date: Apr 8, 2015 ANSI/AAMI/IEC 60601-2-21-2009 (R2014),Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (reaffirmation of ANSI/AAMI SW87-2012,Application of Quality Management System ANSI/AAMI/IEC 60601-2-21-2009) concepts to Medical Device Data Systems (MDDS) (new standard) PINS Date: PINS Date: Apr 22, 2011 Public Review Start: Apr 18, 2014 Public Review Start: Jan 20, 2012 Approval Date: Dec 10, 2014 Approval Date: May 23, 2012 ANSI/AAMI/IEC 60601-2-25-2011,Medical electrical equipment - Part 2 ANSI/AAMI/IEC 60601-1-8-2013,Medical electrical equipment - Part 1 -25: Particular requirements for the basic safety and essential -8: General requirements for basic safety and essential performance - performance of electrocardiographs (national adoption of IEC 60601-2 Collateral Standard: General requirements, tests and guidance for -25:2011 with modifications and revision of ANSI/AAMI EC11-1991 alarm systems in medical electrical equipment and medical electrical (R2007)) systems (identical national adoption of IEC 60601-1-08:2006 and IEC PINS Date: Nov 30, 2007 60601-1-08:2006/A1:2012) Public Review Start: Mar 9, 2012 PINS Date: Mar 1, 2013 Approval Date: May 23, 2012 Public Review Start: Apr 19, 2013 Approval Date: Oct 21, 2013 ANSI/AAMI/IEC 60601-2-27-2011,Medical electrical equipment - Part 2 -27: Particular requirements for the basic safety and essential ANSI/AAMI/IEC 60601-2-16, Ed. 4-2012,Medical electrical equipment - performance of electrocardiographic monitoring equipment (identical Part 2-16: Particular requirements for basic safety and essential national adoption of IEC 60601-2-27:200x and revision of ANSI/AAMI performance of haemodialysis, haemodiafiltration and haemofiltration EC13-2002 (R2007)) equipment (identical national adoption of IEC 60601-2-16, Edition 4.0 PINS Date: Nov 16, 2007 (2012-03-08)) Public Review Start: Mar 6, 2009 PINS Date: Mar 11, 2011 Approval Date: Jun 24, 2011 Public Review Start: Feb 18, 2011 Approval Date: Sep 5, 2012 ANSI/AAMI/IEC 60601-2-4-2010,Medical electrical equipment - Part 2 -4: Particular requirements for basic safety and essential performance ANSI/AAMI/IEC 60601-2-19-2009 (R2014),Medical electrical of cardiac defibrillators (identical national adoption of IEC 60601-2 equipment - Part 2-19: Particular requirements for the basic safety and -4:200X and revision of ANSI/AAMI DF80-2003 (R2010)) essential performance of infant incubators (reaffirmation of PINS Date: Feb 16, 2007 ANSI/AAMI/IEC 60601-2-19-2009) Public Review Start: Mar 6, 2009 PINS Date: Approval Date: Nov 18, 2010 Public Review Start: Apr 18, 2014 Approval Date: Dec 16, 2014 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 4 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/IEC 60601-2-47-2012,Medical electrical equipment - Part 2 ANSI/AAMI/IEC 80601-2-30-2009/A1-2013,Amendment 1 to Medical -47: Particular requirements for the basic safety and essential electrical equipment - Part 2-30: Particular requirements for the basic performance of ambulatory electrocardiographic systems (identical safety and essential performance of automated type non-invasive national adoption of IEC 60601-2-47:2012 and revision of ANSI/AAMI sphygmomanometers (addenda to ANSI/AAMI/IEC 80601-2-30-2009) EC38-2007) PINS Date: Apr 15, 2011 PINS Date: Jan 4, 2008 Public Review Start: Mar 9, 2012 Public Review Start: Mar 9, 2012 Approval Date: Nov 8, 2013 Approval Date: Aug 1, 2012 ANSI/AAMI/IEC 80601-2-30-2009/C1-2009,Medical electrical ANSI/AAMI/IEC 60601-2-50-2009 (R2014),Medical electrical equipment - Part 2-30: Particular requirements for basic safety and equipment - Part 2-50: Particular requirements for the basic safety and essential performance of automated type non-invasive essential performance of infant phototherapy equipment (reaffirmation sphygmomanometers (supplement to ANSI/AAMI/IEC 80601-2-30 of ANSI/AAMI/IEC 60601-2-50-2009) -2009) PINS Date: PINS Date: Oct 30, 2009 Public Review Start: Apr 18, 2014 Public Review Start: Jul 24, 2009 Approval Date: Dec 16, 2014 Approval Date: Dec 10, 2009 ANSI/AAMI/IEC 62304, Ed.1-2006 (R2013),Medical device software - ANSI/AAMI/IEC 80601-2-35-2011,Medical electric equipment – Part 2 Software life cycle processes (reaffirmation of ANSI/AAMI/IEC 62304, -35: Particular requirements for basic safety and essential performance Ed.1-2006) of heating devices using blankets, pads or mattresses and intended for PINS Date: heating in medical use (new standard) Public Review Start: Oct 14, 2011 PINS Date: Nov 19, 2010 Approval Date: Jun 14, 2013 Public Review Start: Jan 21, 2011 Approval Date: Mar 8, 2011 ANSI/AAMI/IEC 62366-1-2015,Medical devices - Application of usability Engineering to medical devices (identical national adoption of ANSI/AAMI/IEC 80601-2-58-2008,Medical electrical equipment - Part 2 IEC 62366-1 (in development) and revision of ANSI/AAMI/IEC 62366 -58: Particular requirements for basic safety and essential performance -2007 (R2013)) of lens removal devices and vitrectomy device for ophthalmic surgery PINS Date: (identical national adoption of IEC 80601-2-58) Public Review Start: Jan 3, 2014 PINS Date: Nov 2, 2007 Approval Date: Feb 23, 2015 Public Review Start: Nov 2, 2007 Approval Date: Dec 10, 2008 ANSI/AAMI/IEC 62366-2007/A1-2014,Medical devices - Application of usability engineering to medical devices - Amendment 1 (identical ANSI/AAMI/IEC 80601-2-58-2014,Medical electrical equipment - Part 2 national adoption of IEC 62366:2007/A1 (in development)) -58: Particular requirements for the basic safety and essential PINS Date: Aug 17, 2012 performance of lens removal devices and vitrectomy devices for Public Review Start: Oct 19, 2012 ophthalmic surgery (identical national adoption of IEC 80601-2-58) Approval Date: Jan 7, 2014 PINS Date: May 24, 2013 Public Review Start: Jun 21, 2013 Approval Date: Sep 10, 2014 ANSI/AAMI/IEC 80001-1-2010,Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities (identical national adoption of IEC 80001-1) ANSI/AAMI/ISO 10079-1-2003 (R2014),Medical suction equipment – PINS Date: Aug 7, 2009 Part 1: Electrically powered suction equipment – Safety requirements Public Review Start: Aug 21, 2009 (reaffirmation of ANSI/ASTM ISO 10079-1-2003) Approval Date: Oct 6, 2010 PINS Date: Public Review Start: Dec 20, 2013 Approval Date: Feb 4, 2014 ANSI/AAMI/IEC 80601-2-30-2009,Medical electrical equipment - Part 2 -30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ANSI/AAMI/ISO 10079-2-2002 (R2014),Medical suction equipment – (identical national adoption of IEC 80601-2-30 (current revision project Part 2: Manually powered suction equipment (reaffirmation of in IEC) and revision of ANSI/AAMI SP10-2002, ANSI/AAMI SP10 ANSI/ASTM ISO 10079-2-2002) -2002/A1-2003, and ANSI/AAMI SP10-2002/A2-2006) PINS Date: PINS Date: May 18, 2007 Public Review Start: Dec 20, 2013 Public Review Start: Nov 30, 2007 Approval Date: Feb 4, 2014 Approval Date: Jul 24, 2009 ANSI/AAMI/ISO 10079-3-2002 (R2014),Medical suction equipment – Part 3: Suction equipment powered from a vacuum or pressure source (reaffirmation of ANSI/ASTM ISO 10079-3-2002) PINS Date: Public Review Start: Dec 20, 2013 Approval Date: Feb 4, 2014 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 5 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 10651-4-2002 (R2014),Lung ventilators – Part 4: ANSI/AAMI/ISO 10993-15-2000 (R2011),Biological evaluation of Particular requirements for operator-powered resuscitators medical devices - Part 15: Identification and quantification of (reaffirmation of ANSI/ASTM/ISO 10651-4-2002) degradation products from metals and alloys (reaffirmation of PINS Date: ANSI/AAMI/ISO 10993-15-2000 (R2006)) Public Review Start: Dec 20, 2013 PINS Date: Approval Date: Feb 4, 2014 Public Review Start: Jun 17, 2011 Approval Date: Nov 16, 2011 ANSI/AAMI/ISO 10651-5-2006 (R2014),Lung ventilators for medical use – Particular requirements for basic safety and essential performance – ANSI/AAMI/ISO 10993-16-2010 (R2014),Biological evaluation of Part 5: Gas-powered emergency resuscitators (reaffirmation of medical devices - Part 16: Toxicokinetic study design for degradation ANSI/ASTM/ISO 10651-5-2006) products and leachables (reaffirmation of ANSI/AAMI/ISO 10993-16 PINS Date: -2010) Public Review Start: Dec 20, 2013 PINS Date: Approval Date: Feb 4, 2014 Public Review Start: Jul 11, 2014 Approval Date: Oct 8, 2014 ANSI/AAMI/ISO 10993-1-2009 (R2013),Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management ANSI/AAMI/ISO 10993-17-2002 (R2012),Biological evaluation of process (reaffirmation of ANSI/AAMI/ISO 10993-1-2009) medical devices - Part 17: Establishment of allowable limits for PINS Date: leachable substances (reaffirmation of ANSI/AAMI/ISO 10993-17-2002 Public Review Start: Aug 16, 2013 (R2008)) Approval Date: Dec 2, 2013 PINS Date: Public Review Start: Aug 17, 2012 Approval Date: Nov 30, 2012 ANSI/AAMI/ISO 10993-10:2010 (R2014),Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (reaffirmation of ANSI/AAMI/ISO 10993-10:2010) ANSI/AAMI/ISO 10993-2-2006 (R2010),Biological evaluation of medical PINS Date: devices - Part 2: Animal welfare requirements (reaffirmation of Public Review Start: Jul 11, 2014 ANSI/AAMI/ISO 10993-2-2006) Approval Date: Oct 8, 2014 PINS Date: Public Review Start: Jul 23, 2010 Approval Date: Dec 14, 2010 ANSI/AAMI/ISO 10993-11-2006 (R2014),Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (reaffirmation of ANSI/AAMI/ISO 10993-11-2006 (R2010)) ANSI/AAMI/ISO 10993-2-2006 (R2014),Biological evaluation of medical PINS Date: devices - Part 2: Animal welfare requirements (reaffirmation of Public Review Start: Apr 18, 2014 ANSI/AAMI/ISO 10993-2-2006 (R2010)) Approval Date: Sep 24, 2014 PINS Date: Public Review Start: Jul 11, 2014 Approval Date: Oct 8, 2014 ANSI/AAMI/ISO 10993-12-2012,Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (identical national adoption of ISO 10993-12 and revision of ANSI/AAMI/ISO 10993-3-2014,Biological evaluation of medical devices ANSI/AAMI/ISO 10993-12-2007) - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity PINS Date: Aug 7, 2009 (identical national adoption of and revision of ANSI/AAMI/ISO 10993-3 Public Review Start: Jun 25, 2010 -2003 (R2013)) Approval Date: Jul 26, 2012 PINS Date: Feb 9, 2007 Public Review Start: Mar 8, 2013 Approval Date: Aug 14, 2014 ANSI/AAMI/ISO 10993-13-2010 (R2014),Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (reaffirmation of ANSI/AAMI/ISO 10993-4-Amd1-2006 (R2009),Biological evaluation of ANSI/AAMI/ISO 10993-13-2010) medical devices - Part 4: Selection of test for interactions with blood PINS Date: (Amendment 1) (reaffirmation of ANSI/AAMI/ISO 10993-4-Amd1-2006) Public Review Start: Jul 11, 2014 PINS Date: Approval Date: Oct 8, 2014 Public Review Start: Oct 10, 2008 Approval Date: Mar 5, 2009 ANSI/AAMI/ISO 10993-14-2001 (R2011),Biological evaluation of medical devices - Part 14: Identification and quantification of ANSI/AAMI/ISO 10993-4:2002 (R2013),Biological evaluation of medical degradation products from ceramics (reaffirmation of ANSI/AAMI/ISO devices - Part 4: Selection of tests for interactions with blood 10993-14-2001 (R2006)) (reaffirmation of ANSI/AAMI/ISO 10993-4-2002 (R2009)) PINS Date: PINS Date: Public Review Start: Jun 17, 2011 Public Review Start: Aug 16, 2013 Approval Date: Nov 16, 2011 Approval Date: Nov 26, 2013 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 6 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 10993-5-2009 (R2014),Biological evaluation of medical ANSI/AAMI/ISO 11137-3-2006 (R2010),Sterilization of health care devices - Part 5: Tests for in vitro cytotoxicity (reaffirmation of products - Radiation - Part 3: Guidance on dosimetric aspects ANSI/AAMI/ISO 10993-5-2009) (reaffirmation of ANSI/AAMI/ISO 11137-3-2006) PINS Date: PINS Date: Public Review Start: Aug 16, 2013 Public Review Start: Jul 3, 2009 Approval Date: Feb 6, 2014 Approval Date: Apr 20, 2010 ANSI/AAMI/ISO 10993-6-2007 (R2014),Biological evaluation of medical ANSI/AAMI/ISO 11138-1-2006 (R2010),Sterilization of health care devices - Part 6: Tests for local effects after implantation (reaffirmation products - Biological indicators - Part 1: General requirements of ANSI/AAMI/ISO 10993-6-2007 (R2010)) (reaffirmation of ANSI/AAMI/ISO 11138-1-2006) PINS Date: PINS Date: Public Review Start: Apr 18, 2014 Public Review Start: Sep 11, 2009 Approval Date: Sep 24, 2014 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 10993-7-2008 (R2012),Biological evaluation of medical ANSI/AAMI/ISO 11138-2-2006 (R2010),Sterilization of health care devices - Part 7: Ethylene oxide sterilization residuals (reaffirmation of products - Biological indicators - Part 2: Biological indicators for ANSI/AAMI/ISO 10993-7-2008) ethylene oxide sterilization processes (reaffirmation of ANSI/AAMI/ISO PINS Date: 11138-2-2006) Public Review Start: Dec 16, 2011 PINS Date: Approval Date: Jun 1, 2012 Public Review Start: Sep 11, 2009 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 10993-9-1999 (R2014),Biological evaluation of medical devices - Part 9: Framework for identification and quantification of ANSI/AAMI/ISO 11138-3-2006 (R2010),Sterilization of health care potential degradation products (reaffirmation of ANSI/AAMI/ISO 10993 products - Biological indicators - Part 3: Biological indicators for moist -9-2009) heat sterilization processes (reaffirmation of ANSI/AAMI/ISO 11138-3 PINS Date: -2006) Public Review Start: Apr 18, 2014 PINS Date: Approval Date: Sep 23, 2014 Public Review Start: Sep 11, 2009 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 11135-2015,Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and ANSI/AAMI/ISO 11138-4-2006 (R2010),Sterilization of health care routine control of a sterilization process for medical devices (identical products - Biological indicators - Part 4: Biological indicators for dry national adoption of ISO 11135:2014 and revision of ANSI/AAMI/ISO heat sterilization processes (reaffirmation of ANSI/AAMI/ISO 11138-4 11135-1-2007) -2006) PINS Date: PINS Date: Public Review Start: Jul 25, 2014 Public Review Start: Sep 11, 2009 Approval Date: Jul 27, 2015 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 11137-1-2006 (R2010),Sterilization of health care ANSI/AAMI/ISO 11138-5-2006 (R2010),Sterilization of health care products - Radiation - Part 1: Requirements for the development, products - Biological indicators - Part 5: Biological indicators for low- validation and routine control of a sterilization process for medical temperature steam and formaldehyde sterilization processes devices (reaffirmation of ANSI/AAMI/ISO 11137-1-2006) (reaffirmation of ANSI/AAMI/ISO 11138-5-2006) PINS Date: PINS Date: Public Review Start: Jul 3, 2009 Public Review Start: Sep 11, 2009 Approval Date: Apr 20, 2010 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 11137-1:2006/Amd 1-2013,Sterilization of health care ANSI/AAMI/ISO 11140-1-2014,Sterilization of health care products - products - Radiation - Part 1: Requirements for development, Chemical indicators - Part 1: General requirements (identical national validation and routine control of a sterilization process for medical adoption of ISO/DIS 11140-1 and revision of ANSI/AAMI/ISO 11140-1 devices - Amendment 1 (identical national adoption of ISO 11137 -2005 (R2010)) -1:2006/DAmd 1) PINS Date: Dec 2, 2011 PINS Date: Jul 20, 2012 Public Review Start: Sep 7, 2012 Public Review Start: Oct 26, 2012 Approval Date: Sep 10, 2014 Approval Date: Dec 30, 2013 ANSI/AAMI/ISO 11140-3-2007 (R2012),Sterilization of health care ANSI/AAMI/ISO 11137-2, third edition-2013,Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use products - Radiation - Part 2: Establishing the sterilization dose in the Bowie and Dick-type steam penetration test (reaffirmation of (revision of ANSI/AAMI/ISO 11137-2-2012) ANSI/AAMI/ISO 11140-3-2007) PINS Date: Feb 22, 2013 PINS Date: Public Review Start: Feb 22, 2013 Public Review Start: Oct 21, 2011 Approval Date: Jul 10, 2013 Approval Date: Aug 7, 2012 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 7 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 11140-4-2007 (R2012),Sterilization of health care ANSI/AAMI/ISO 11712-2014,Anaesthetic and respiratory equipment – products - Chemical indicators - Part 4: Class 2 indicators as an supralaryngeal airways and connectors (identical national adoption of alternative to the Bowie and Dick-type test for detection of steam ISO 11712) penetration (reaffirmation of ANSI/AAMI/ISO 11140-4-2007) PINS Date: Nov 22, 2013 PINS Date: Public Review Start: Jan 3, 2014 Public Review Start: Oct 21, 2011 Approval Date: Feb 18, 2014 Approval Date: Aug 7, 2012 ANSI/AAMI/ISO 11737-1-2006 (R2011),Sterilization of medical devices ANSI/AAMI/ISO 11140-5-2007 (R2012),Sterilization of health care - Microbiological methods - Part 1: Determination of a population of products - Chemical indicators - Part 5: Class 2 indicators for Bowie and microorganisms on products (reaffirmation of ANSI/AAMI/ISO 11737-1 Dick-type air removal tests (reaffirmation of ANSI/AAMI/ISO 11140-5 -2006) -2007) PINS Date: PINS Date: Public Review Start: Jun 3, 2011 Public Review Start: Oct 21, 2011 Approval Date: Nov 16, 2011 Approval Date: Aug 7, 2012 ANSI/AAMI/ISO 11737-2-2009 (R2014),Sterilization of medical devices ANSI/AAMI/ISO 11195-2009,Gas mixers for medical use – stand-alone - Microbiological methods - Part 2: Tests of sterility performed in the gas mixers (national adoption with modifications of ISO 11195) definition, validation and maintenance of a sterilization process PINS Date: Apr 3, 2009 (reaffirmation of ANSI/AAMI/ISO 11737-2-2009) Public Review Start: May 15, 2009 PINS Date: Approval Date: Jun 30, 2009 Public Review Start: Jan 31, 2014 Approval Date: Oct 13, 2014 ANSI/AAMI/ISO 11607-1-2006 (R2010),Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ANSI/AAMI/ISO 13022-2012,Medical products containing viable barrier systems, and packaging (reaffirmation of ANSI/AAMI/ISO 11607 human cells -- Application of risk management and requirements for -1-2006) processing practices (identical national adoption of ISO 13022) PINS Date: PINS Date: May 8, 2009 Public Review Start: Aug 14, 2009 Public Review Start: Oct 29, 2010 Approval Date: Dec 14, 2010 Approval Date: Jun 18, 2012 ANSI/AAMI/ISO 11607-1:2006, A1-2014,Amendment 1 to ANSI/AAMI/ISO 13408-1-2008 (R2011),Aseptic processing of health ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized care products - Part 1: General requirements (reaffirmation of medical devices - Part 1: Requirements for materials, sterile barrier ANSI/AAMI/ISO 13408-1-2008) systems, and packaging (addenda to ANSI/AAMI/ISO 11607-1:2006) PINS Date: PINS Date: Public Review Start: Aug 5, 2011 Public Review Start: Apr 19, 2013 Approval Date: Dec 14, 2011 Approval Date: Sep 10, 2014 ANSI/AAMI/ISO 13408-1-2008/A1-2013,Aseptic processing of health ANSI/AAMI/ISO 11607-2-2006 (R2010),Packaging for terminally care products - Part 1: General requirements - Amendment 1 (addenda sterilized medical devices - Part 2: Validation requirements for forming, to ANSI/AAMI/ISO 13408-1-2008) sealing and assembly processes (reaffirmation of ANSI/AAMI/ISO PINS Date: Jul 22, 2011 11607-2-2006) Public Review Start: Oct 14, 2011 PINS Date: Approval Date: Mar 27, 2013 Public Review Start: Aug 14, 2009 Approval Date: Dec 14, 2010 ANSI/AAMI/ISO 13408-2-2003 (R2013),Aseptic processing of health care products - Part 2: Filtration (reaffirmation of ANSI/AAMI/ISO ANSI/AAMI/ISO 11607-2:2006, A1-2014,Amendment 1 to 13408-2-2003) ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized PINS Date: medical devices - Part 2: Validation requirements for forming, sealing Public Review Start: Sep 6, 2013 and assembly processes (addenda to ANSI/AAMI/ISO 11607-2:2006) Approval Date: Dec 4, 2013 PINS Date: Public Review Start: Apr 19, 2013 ANSI/AAMI/ISO 13408-3-2012 (R2015),Aseptic processing of health Approval Date: Sep 10, 2014 care products - Part 3: Lyophilization (reaffirmation of ANSI/AAMI/ISO 13408-3-2006 (R2012)) ANSI/AAMI/ISO 11658-2012,Cardiovascular implants and PINS Date: extracorporeal systems - Blood/tissue contact surface modifications for Public Review Start: Feb 13, 2015 extracorporeal perfusion systems (identical national adoption of ISO Approval Date: Jul 13, 2015 11658) PINS Date: Oct 23, 2009 Public Review Start: May 6, 2011 Approval Date: Aug 20, 2012 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 8 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 13408-4-2005 (R2012),Aseptic processing of health ANSI/AAMI/ISO 14155-1-2003 (R2008),Clinical investigation of medical care products - Part 4: Clean-in-place technologies (reaffirmation of devices for human subjects - Part 1: General requirements ANSI/AAMI/ISO 13408-4-2005) (reaffirmation of ANSI/AAMI/ISO 14155-1-2003) PINS Date: PINS Date: Public Review Start: Aug 17, 2012 Public Review Start: Sep 19, 2008 Approval Date: Nov 30, 2012 Approval Date: Dec 19, 2008 ANSI/AAMI/ISO 13408-4-2005 (R2014),Aseptic processing of health ANSI/AAMI/ISO 14155-2-2003 (R2008),Clinical investigation of medical care products - Part 4: Clean-in-place technologies (reaffirmation of devices for human subjects - Part 2: Clinical investigation plans ANSI/AAMI/ISO 13408-4-2005 (R2012)) (reaffirmation of ANSI/AAMI/ISO 14155-2-2003) PINS Date: PINS Date: Public Review Start: Jan 31, 2014 Public Review Start: Sep 19, 2008 Approval Date: Oct 13, 2014 Approval Date: Dec 19, 2008 ANSI/AAMI/ISO 13408-5-2012 (R2015),Aseptic processing of health ANSI/AAMI/ISO 14155-2010,Clinical investigation of medical devices care products - Part 5: Sterilization in place (reaffirmation of for human subjects - Good clinical practice (identical national ANSI/AAMI/ISO 13408-5-2006 (R2012)) adoption of ISO 14155) PINS Date: PINS Date: Jan 23, 2009 Public Review Start: May 1, 2015 Public Review Start: Nov 13, 2009 Approval Date: Aug 3, 2015 Approval Date: Dec 30, 2010 ANSI/AAMI/ISO 13408-6-2005 (R2013),Aseptic processing of health ANSI/AAMI/ISO 14160-2011,Sterilization of health care products - care products - Part 6: Isolator systems (reaffirmation of Liquid chemical sterilizing agents for single-use medical devices utilizing ANSI/AAMI/ISO 13408-6-2005) animal tissues and their derivatives - Requirements for PINS Date: characterization, development, validation and routine control of a Public Review Start: Aug 16, 2013 sterilization process for medical devices (identical national adoption of Approval Date: Nov 26, 2013 ISO 14160 and revision of ANSI/AAMI/ISO 14160-1998 (R2008)) PINS Date: Jan 23, 2009 Public Review Start: Apr 24, 2009 ANSI/AAMI/ISO 13408-6-2005/A1-2013,Aseptic processing of health Approval Date: Dec 5, 2011 care products - Part 6: Isolator systems - Amendment 1 (addenda to ANSI/AAMI/ISO 13408-6-2005) PINS Date: Sep 23, 2011 ANSI/AAMI/ISO 14161-2009 (R2014),Sterilization of health care Public Review Start: May 4, 2012 products - Biological indicators - Guidance for the selection, use and Approval Date: Mar 11, 2013 interpretation of results (reaffirmation of ANSI/AAMI/ISO 14161-2009) PINS Date: Public Review Start: Nov 8, 2013 ANSI/AAMI/ISO 13408-7-2012,Aseptic processing of health care Approval Date: Apr 2, 2014 products - Part 7: Alternative processes for atypical medical devices and combination products (identical national adoption of ISO 13408-7 (under development)) ANSI/AAMI/ISO 14408-2009,Tracheal tubes designed for laser surgery PINS Date: – requirements for marking and accompanying information (identical Public Review Start: Mar 18, 2011 national adoption of ISO 14408:2005) Approval Date: Jul 26, 2012 PINS Date: Jul 18, 2008 Public Review Start: Mar 6, 2009 Approval Date: Apr 21, 2009 ANSI/AAMI/ISO 13485-2003 (R2013),Medical devices - Quality management systems - Requirements for regulatory purposes (reaffirmation of ANSI/AAMI/ISO 13485-2003 (R2009)) ANSI/AAMI/ISO 14708-3-2008 (R2011),Implants for surgery - Active PINS Date: implantable medical devices - Part 3: Implantable neurostimulators Public Review Start: Aug 30, 2013 (reaffirmation of ANSI/AAMI/ISO 14708-3-2008) Approval Date: Oct 23, 2013 PINS Date: Public Review Start: Jun 3, 2011 Approval Date: Nov 16, 2011 ANSI/AAMI/ISO 14117-2012,Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac ANSI/AAMI/ISO 14708-4-2008 (R2011),Implants for surgery - Active resynchronization devices (identical national adoption of ISO 14117 implantable medical devices - Part 4: Implantable infusion pumps and revision of ANSI/AAMI PC69-2007) (reaffirmation of ANSI/AAMI/ISO 14708-4-2008) PINS Date: Jul 23, 2010 PINS Date: Public Review Start: Jun 29, 2012 Public Review Start: Jun 17, 2011 Approval Date: Nov 30, 2012 Approval Date: Nov 16, 2011 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 9

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Preview Approved American National Standards

The data in this document is reported as of Monday, September 28, 2015 Approved American National Standards User Guide for American National Standards (ANS) related Data Listed below are approved American National Standards (ANS) as of 9/28/2015. Additional information about these ANS has been published in ANSI’s Standards Action during the standards development cycle as indicated by the PINS Date and/or Public Review Start Date and Approval Date. To review this additional information, archived issues of ANSI's Standards Action in (PDF) format are available at (www.ansi.org/standardsaction). Questions concerning a particular ANS should be directed to the sponsoring ANSI-Accredited Standards Developer (ASD). Some ANS are available for purchase at http://webstore.ansi.org/. Information about proposed ANS is available in a separate document at www.ansi.org/proposedANSprojects . The procedures that govern the ANS process are called the “ANSI Essential Requirements: Due process requirements for American National Standards” www.ansi.org/essentialrequirements. A list of all ASDs is available at www.ansi.org/asd. Questions concerning the ANS process may be directed to [email protected]. Thank you for your interest. ANSI H35.5-2013,Standard Nomenclature System for Aluminum Metal 3-A (3-A Sanitary Standards, Inc. ) Matrix Composite Materials (revision of ANSI H35.5-1993 (R2009)) www.3-a.org PINS Date: Aug 17, 2012 Public Review Start: May 31, 2013 Approval Date: Nov 7, 2013 ANSI/3-A 00-00-2014,3-A® Sanitary Standards for General Requirements (new standard) PINS Date: Jan 27, 2012 AAMI (Association for the Advancement of Medical Public Review Start: May 23, 2014 Instrumentation ) Approval Date: Sep 8, 2014 www.aami.org ANSI/AAM/IEC 60601-1-2-2014,Medical electrical equipment - Part 1 AA (ASC H35) (Aluminum Association ) -2: General requirements for basic safety and essential performance - www.aluminum.org Collateral standard: Electromagnetic disturbances - Requirements and tests (identical national adoption of IEC 60601-1-2 and revision of ANSI/AAMI/IEC 60601-1-2, Ed.2-2007 (R2012)) ANSI H35.1/H35.1(M)-2013,Standard Alloy and Temper Designation PINS Date: Systems for Aluminum (revision of ANSI H35.1/H35.1(M)-2009) Public Review Start: Aug 17, 2012 PINS Date: Aug 17, 2012 Approval Date: May 8, 2014 Public Review Start: May 31, 2013 Approval Date: Nov 7, 2013 ANSI/AAMI 11663-2014,Quality of dialysis fluid for haemodialysis and related therapies (national adoption of ISO 11663:2014 with ANSI H35.2-2013,Standard Dimensional Tolerances for Aluminum Mill modifications and revision of ANSI/AAMI/ISO 11663-2009 (Ed1)) Products (revision of ANSI H35.2-2009) PINS Date: Feb 8, 2013 PINS Date: Aug 17, 2012 Public Review Start: Feb 7, 2014 Public Review Start: May 31, 2013 Approval Date: Aug 8, 2014 Approval Date: Nov 7, 2013 ANSI/AAMI 13958-2014,Concentrates for haemodialysis and related ANSI H35.2(M)-2013,Standard Dimensional Tolerances for Aluminum therapies (national adoption of ISO 13958:2014 with modifications and Mill Products (revision of ANSI H35.2(M)-2009) revision of ANSI/AAMI/ISO 13958-2009) PINS Date: Aug 17, 2012 PINS Date: Feb 8, 2013 Public Review Start: May 31, 2013 Public Review Start: Feb 14, 2014 Approval Date: Nov 7, 2013 Approval Date: Aug 15, 2014 ANSI H35.3-1997 (R2013),Standard Designation System for Aluminum ANSI/AAMI 13959-2014,Water for haemodialysis and related therapies Hardeners (reaffirmation of ANSI H35.3-1997 (R2009)) (national adoption of ISO 13959:2014 with modifications and revision PINS Date: Aug 17, 2012 of ANSI/AAMI/ISO 13959-2009) Public Review Start: May 31, 2013 PINS Date: Feb 8, 2013 Approval Date: Nov 7, 2013 Public Review Start: Feb 14, 2014 Approval Date: Aug 15, 2014 ANSI H35.4-2006 (R2013),Standard Designation System for Unalloyed Aluminum (reaffirmation of ANSI H35.4-2006 (R2009)) ANSI/AAMI 23500-2014,Guidance for the preparation and quality PINS Date: Aug 17, 2012 management of fluids for haemodialysis and related therapies Public Review Start: May 31, 2013 (national adoption of ISO 23500:2014 with modifications and revision Approval Date: Nov 7, 2013 of ANSI/AAMI/ISO 23500-2011) PINS Date: Feb 8, 2013 Public Review Start: Feb 14, 2014 Approval Date: Aug 15, 2014 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 0 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI 26722-2014,Water treatment equipment for haemodialysis ANSI/AAMI EC71-2001 (R2013),Standard communications protocol - applications and related therapies (national adoption of ISO Computer assisted electrocardiography (reaffirmation of ANSI/AAMI 26722:2014 with modifications and revision of ANSI/AAMI/ISO 26722 EC71-2001 (R2007)) -2009) PINS Date: PINS Date: Feb 8, 2013 Public Review Start: Nov 2, 2012 Public Review Start: Feb 14, 2014 Approval Date: Sep 19, 2013 Approval Date: Aug 8, 2014 ANSI/AAMI EQ56-2013,Recommended practice for a medical ANSI/AAMI AT6-2013,Autologous transfusion devices (revision of equipment management program (revision of ANSI/AAMI EQ56-1999 ANSI/AAMI AT6-2005 (R2011)) (R2008)) PINS Date: PINS Date: Feb 25, 2011 Public Review Start: Feb 15, 2013 Public Review Start: Jul 27, 2012 Approval Date: Aug 27, 2013 Approval Date: Mar 13, 2013 ANSI/AAMI BE83-2006 (R2011),Biological evaluation of medical ANSI/AAMI EQ89-2015,Guidance for the use of medical equipment devices - Part 18: Chemical characterization of materials (reaffirmation maintenance strategies and procedures (new standard) of ANSI/AAMI BE83-2006) PINS Date: Aug 3, 2012 PINS Date: Public Review Start: Jul 25, 2014 Public Review Start: Aug 12, 2011 Approval Date: Feb 12, 2015 Approval Date: Dec 2, 2011 ANSI/AAMI ES60601-1-2005 C1-2009 and A2 (R2012),Medical ANSI/AAMI BF64-2012,Leukocyte reduction filters (revision of electrical equipment - Part 1: General requirements for basic safety and ANSI/AAMI BF64-2002 (R2011)) essential performance (reaffirmation of ANSI/AAMI ES60601-1-2005) PINS Date: Mar 30, 2012 PINS Date: Public Review Start: Apr 13, 2012 Public Review Start: Oct 14, 2011 Approval Date: Nov 29, 2012 Approval Date: Jan 17, 2012 ANSI/AAMI BF7-2012,Blood transfusion microfilters (revision of ANSI/AAMI ES60601-1-2005, A1-2012,Medical electrical equipment - ANSI/AAMI BF7-1989 (R2011)) Part 1: General requirements for basic safety and essential PINS Date: Mar 30, 2012 performance Amendment 1 (supplement to ANSI/AAMI ES60601-1 Public Review Start: Apr 27, 2012 -2005) Approval Date: Nov 30, 2012 PINS Date: Public Review Start: Apr 22, 2011 Approval Date: Aug 21, 2012 ANSI/AAMI BP22-1994 (R2011),Blood pressure transducers (reaffirmation of ANSI/AAMI BP22-1994 (R2006)) PINS Date: ANSI/AAMI HA60601-1-11-2015,Medical electrical equipment - Part 1 Public Review Start: Sep 23, 2011 -11: General requirements for basic safety and essential performance - Approval Date: Dec 14, 2011 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (national adoption of IEC 60601-1-11:2015 with modifications and ANSI/AAMI EC12-2000 (R2010),Disposable ECG electrodes revision of ANSI/AAMI HA60601-1-11-2011) (reaffirmation of ANSI/AAMI EC12-2000 (R2005)) PINS Date: Nov 8, 2013 PINS Date: Public Review Start: Mar 27, 2015 Public Review Start: Jan 22, 2010 Approval Date: Aug 25, 2015 Approval Date: Aug 24, 2010 ANSI/AAMI HE75-2009 (R2013),Human factors engineering - Design of ANSI/AAMI EC53-2013,ECG trunk cables and patient leadwires medical devices (reaffirmation of ANSI/AAMI HE75-2009) (revision, redesignation and consolidation of ANSI/AAMI EC53-1995 PINS Date: (R2008) and ANSI/AAMI EC53/A1-1998 (R2008)) Public Review Start: Jul 12, 2013 PINS Date: Mar 13, 2009 Approval Date: Nov 26, 2013 Public Review Start: Jun 3, 2011 Approval Date: Nov 19, 2013 ANSI/AAMI ID26-2004 (R2013),Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers ANSI/AAMI EC57-2012,Testing and reporting performance results of (reaffirmation of ANSI/AAMI ID26-2004 (R2009)) cardiac rhythm and ST segment measurement algorithms (revision of PINS Date: ANSI/AAMI EC57-1998 (R2008)) Public Review Start: Aug 16, 2013 PINS Date: Mar 13, 2009 Approval Date: Nov 26, 2013 Public Review Start: Jun 3, 2011 Approval Date: Dec 18, 2012 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 1 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI ID54-1996 (R2012),Enteral feeding set adapters and ANSI/AAMI ST15883-3-2012 (ISO 15883-3-2006)MOD,Washer- connectors (reaffirmation of ANSI/AAMI ID54-1996 (R2005)) disinfectors - Part 3: Requirements and tests for washer-disinfectors PINS Date: employing thermal disinfection for human waste containers (national Public Review Start: May 20, 2011 adoption with modifications of ISO 15883-3:2006) Approval Date: Jan 17, 2012 PINS Date: May 19, 2006 Public Review Start: Aug 31, 2012 Approval Date: Dec 10, 2012 ANSI/AAMI NS28-1988 (R2015),Intracranial pressure monitoring devices (reaffirmation of ANSI/AAMI NS28-1988 (R2010)) PINS Date: ANSI/AAMI ST24-1999 (R2013),Automatic, general-purpose ethylene Public Review Start: Apr 17, 2015 oxide sterilizers and ethylene oxide sterilant sources intended for use in Approval Date: Aug 31, 2015 health care facilities (reaffirmation of ANSI/AAMI ST24-1999 (R2009)) PINS Date: Public Review Start: Aug 16, 2013 ANSI/AAMI NS4-2013,Transcutaneous electrical stimulators (new Approval Date: Nov 26, 2013 standard) PINS Date: Aug 10, 2012 Public Review Start: Sep 21, 2012 ANSI/AAMI ST40-2004 (R2010),Table-top dry heat (heated air) Approval Date: Mar 20, 2013 sterilization and sterility assurance in health care facilities (reaffirmation of ANSI/AAMI ST40-2004) PINS Date: ANSI/AAMI PB70-2012,Liquid barrier performance and classification of Public Review Start: Dec 18, 2009 protective apparel and drapes intended for use in health care facilities Approval Date: Mar 24, 2010 (revision of ANSI/AAMI PB70-2003 (R2009)) PINS Date: Jan 23, 2009 Public Review Start: Jul 1, 2011 ANSI/AAMI ST41-2008 (R2012),Ethylene oxide sterilization in health Approval Date: Jun 21, 2012 care facilities: Safety and effectiveness (reaffirmation of ANSI/AAMI ST41-2008) PINS Date: ANSI/AAMI RD47-2008 (R2013),Reprocessing of hemodialyzers Public Review Start: Aug 10, 2012 (reaffirmation of ANSI/AAMI RD47-2008) Approval Date: Nov 29, 2012 PINS Date: Public Review Start: May 10, 2013 Approval Date: Oct 4, 2013 ANSI/AAMI ST50-2004 (R2010),Dry heat (heated air) sterilizers (reaffirmation of ANSI/AAMI ST50-2004) PINS Date: ANSI/AAMI ST15883-1-2009/A1-2014,Washer-disinfectors - Part 1: Public Review Start: Dec 18, 2009 General requirements, terms and definitions and tests - Amendment 1 Approval Date: Mar 24, 2010 (identical national adoption of ISO 15883-1:2006/DAmd 1) PINS Date: Sep 23, 2011 Public Review Start: May 25, 2012 ANSI/AAMI ST55-2010 (R2014),Table-top steam sterilizers Approval Date: Jul 17, 2014 (reaffirmation of ANSI/AAMI ST55-2010) PINS Date: Public Review Start: Feb 14, 2014 ANSI/AAMI ST15883-1-2009/A2-2012,Washer-disinfectors - Part 1: Approval Date: Sep 19, 2014 General requirements, terms and definitions and tests, Amendment 2 (supplement to ANSI/AAMI ST15883-1-2009) PINS Date: Oct 28, 2011 ANSI/AAMI ST58-2013,Chemical sterilization and high-level Public Review Start: Dec 23, 2011 disinfection in health care facilities (revision of ANSI/AAMI ST58-2005 Approval Date: Aug 23, 2012 (R2010)) PINS Date: Sep 10, 2010 Public Review Start: Oct 5, 2012 ANSI/AAMI ST15883-2-2013 (ISO 15883-2-2006 MOD),Washer- Approval Date: Aug 21, 2013 disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc (national ANSI/AAMI ST65-2008 (R2013),Processing of reusable surgical textiles adoption with modifications of ISO 15883-2:2006) for use in health care facilities (reaffirmation of ANSI/AAMI ST65-2008) PINS Date: May 19, 2006 PINS Date: Public Review Start: Aug 31, 2012 Public Review Start: Aug 16, 2013 Approval Date: Jan 9, 2013 Approval Date: Dec 2, 2013 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 2 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI ST67-2011,Sterilization of health care products - ANSI/AAMI ST79-2010/A3.1-2012,Comprehensive guide to steam Requirements and guidance for selecting a sterility assurance level sterilization and sterility assurance in health care facilities (addenda to (SAL) for products labeled "sterile" (revision of ANSI/AAMI ST67-2003 ANSI/AAMI ST79-2010) (R2008)) PINS Date: Feb 17, 2012 PINS Date: Jan 23, 2009 Public Review Start: Mar 9, 2012 Public Review Start: Sep 17, 2010 Approval Date: Aug 22, 2012 Approval Date: Apr 11, 2011 ANSI/AAMI ST79-2010/A3.2-2012,Comprehensive guide to steam ANSI/AAMI ST72-2011,Bacterial endotoxin -Test methods, routine sterilization and sterility assurance in health care facilities (addenda to monitoring and alternatives to batch testing (revision of ANSI/AAMI ANSI/AAMI ST79-2010) ST72-2002 (R2010)) PINS Date: Feb 17, 2012 PINS Date: Jan 23, 2009 Public Review Start: Mar 9, 2012 Public Review Start: Mar 11, 2011 Approval Date: Aug 23, 2012 Approval Date: Dec 19, 2011 ANSI/AAMI ST79-2010/A3.3-2012,Comprehensive guide to steam ANSI/AAMI ST77-2013,Containment devices for reusable medical sterilization and sterility assurance in health care facilities (addenda to device sterilization (revision of ANSI/AAMI ST77-2006 (R2010)) ANSI/AAMI ST79-2010) PINS Date: Dec 24, 2010 PINS Date: Feb 17, 2012 Public Review Start: Jul 13, 2012 Public Review Start: Mar 9, 2012 Approval Date: Feb 1, 2013 Approval Date: Aug 23, 2012 ANSI/AAMI ST79-2010 (R2014),Comprehensive guide to steam ANSI/AAMI ST79-2010/A3.4-2012,Comprehensive guide to steam sterilization and sterility assurance in health care facilities sterilization and sterility assurance in health care facilities (addenda to (reaffirmation of ANSI/AAMI ST79-2010, A1:2010, A2:2011, A3:2012, ANSI/AAMI ST79-2010) A4:2013) PINS Date: Feb 17, 2012 PINS Date: Public Review Start: Mar 9, 2012 Public Review Start: Feb 14, 2014 Approval Date: Aug 23, 2012 Approval Date: Sep 23, 2014 ANSI/AAMI ST79-2010/A3.5-2012,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.1-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012 PINS Date: Feb 25, 2011 Public Review Start: Mar 9, 2012 Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012 Approval Date: Aug 8, 2011 ANSI/AAMI ST79-2010/A3.6-2012,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.2-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012 PINS Date: Feb 25, 2011 Public Review Start: Mar 16, 2012 Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012 Approval Date: Aug 8, 2011 ANSI/AAMI ST79-2010/A3.7-2012,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.3-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012 PINS Date: Feb 25, 2011 Public Review Start: Mar 16, 2012 Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012 Approval Date: Aug 8, 2011 ANSI/AAMI ST79-2010/A4.1-2013,Comprehensive guide to steam ANSI/AAMI ST79-2010/A2.5-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010) ANSI/AAMI ST79-2010) PINS Date: Jan 18, 2013 PINS Date: Feb 25, 2011 Public Review Start: Feb 22, 2013 Public Review Start: Apr 1, 2011 Approval Date: Oct 14, 2013 Approval Date: Sep 19, 2011 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 3 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI ST79-2010/A4.2-2013,Comprehensive guide to steam ANSI/AAMI/IEC 60601-2-2-2009 (R2014),Medical electrical equipment sterilization and sterility assurance in health care facilities (addenda to - Part 2-2: Particular requirements for the basic safety and essential ANSI/AAMI ST79-2010) performance of high frequency surgical equipment and high frequency PINS Date: Jan 18, 2013 surgical accessories (reaffirmation of ANSI/AAMI/IEC 60601-2-2-2009) Public Review Start: Jun 28, 2013 PINS Date: Approval Date: Oct 14, 2013 Public Review Start: Apr 18, 2014 Approval Date: Dec 10, 2014 ANSI/AAMI ST8-2013,Hospital steam sterilizers (revision of ANSI/AAMI ST8-2008) ANSI/AAMI/IEC 60601-2-20-2009,Medical electrical equipment - Part 2 PINS Date: Aug 19, 2011 -20: Particular requirements for basic safety and essential performance Public Review Start: Aug 31, 2012 of transport incubators (identical national adoption of IEC 60601-2-20 Approval Date: Apr 25, 2013 and revision of ANSI/AAMI II51-2004) PINS Date: Oct 20, 2006 Public Review Start: Jul 6, 2007 ANSI/AAMI ST81-2004 (R2010),Sterilization of medical devices - Approval Date: Apr 3, 2009 Information to be provided by the manufacturer for the processing of resterilizable medical devices (reaffirmation of ANSI/AAMI ST81-2004) PINS Date: ANSI/AAMI/IEC 60601-2-20-2009 (R2014),Medical electrical Public Review Start: Dec 18, 2009 equipment - Part 2-20: Particular requirements for the basic safety and Approval Date: Mar 24, 2010 essential performance of infant transport incubators (reaffirmation of ANSI/AAMI/IEC 60601-2-20-2009) PINS Date: ANSI/AAMI ST91-2015,Flexible and semi-rigid endoscope reprocessing Public Review Start: Apr 18, 2014 in health care facilities (new standard) Approval Date: Dec 10, 2014 PINS Date: May 16, 2014 Public Review Start: Aug 1, 2014 Approval Date: Apr 8, 2015 ANSI/AAMI/IEC 60601-2-21-2009 (R2014),Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (reaffirmation of ANSI/AAMI SW87-2012,Application of Quality Management System ANSI/AAMI/IEC 60601-2-21-2009) concepts to Medical Device Data Systems (MDDS) (new standard) PINS Date: PINS Date: Apr 22, 2011 Public Review Start: Apr 18, 2014 Public Review Start: Jan 20, 2012 Approval Date: Dec 10, 2014 Approval Date: May 23, 2012 ANSI/AAMI/IEC 60601-2-25-2011,Medical electrical equipment - Part 2 ANSI/AAMI/IEC 60601-1-8-2013,Medical electrical equipment - Part 1 -25: Particular requirements for the basic safety and essential -8: General requirements for basic safety and essential performance - performance of electrocardiographs (national adoption of IEC 60601-2 Collateral Standard: General requirements, tests and guidance for -25:2011 with modifications and revision of ANSI/AAMI EC11-1991 alarm systems in medical electrical equipment and medical electrical (R2007)) systems (identical national adoption of IEC 60601-1-08:2006 and IEC PINS Date: Nov 30, 2007 60601-1-08:2006/A1:2012) Public Review Start: Mar 9, 2012 PINS Date: Mar 1, 2013 Approval Date: May 23, 2012 Public Review Start: Apr 19, 2013 Approval Date: Oct 21, 2013 ANSI/AAMI/IEC 60601-2-27-2011,Medical electrical equipment - Part 2 -27: Particular requirements for the basic safety and essential ANSI/AAMI/IEC 60601-2-16, Ed. 4-2012,Medical electrical equipment - performance of electrocardiographic monitoring equipment (identical Part 2-16: Particular requirements for basic safety and essential national adoption of IEC 60601-2-27:200x and revision of ANSI/AAMI performance of haemodialysis, haemodiafiltration and haemofiltration EC13-2002 (R2007)) equipment (identical national adoption of IEC 60601-2-16, Edition 4.0 PINS Date: Nov 16, 2007 (2012-03-08)) Public Review Start: Mar 6, 2009 PINS Date: Mar 11, 2011 Approval Date: Jun 24, 2011 Public Review Start: Feb 18, 2011 Approval Date: Sep 5, 2012 ANSI/AAMI/IEC 60601-2-4-2010,Medical electrical equipment - Part 2 -4: Particular requirements for basic safety and essential performance ANSI/AAMI/IEC 60601-2-19-2009 (R2014),Medical electrical of cardiac defibrillators (identical national adoption of IEC 60601-2 equipment - Part 2-19: Particular requirements for the basic safety and -4:200X and revision of ANSI/AAMI DF80-2003 (R2010)) essential performance of infant incubators (reaffirmation of PINS Date: Feb 16, 2007 ANSI/AAMI/IEC 60601-2-19-2009) Public Review Start: Mar 6, 2009 PINS Date: Approval Date: Nov 18, 2010 Public Review Start: Apr 18, 2014 Approval Date: Dec 16, 2014 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 4 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/IEC 60601-2-47-2012,Medical electrical equipment - Part 2 ANSI/AAMI/IEC 80601-2-30-2009/A1-2013,Amendment 1 to Medical -47: Particular requirements for the basic safety and essential electrical equipment - Part 2-30: Particular requirements for the basic performance of ambulatory electrocardiographic systems (identical safety and essential performance of automated type non-invasive national adoption of IEC 60601-2-47:2012 and revision of ANSI/AAMI sphygmomanometers (addenda to ANSI/AAMI/IEC 80601-2-30-2009) EC38-2007) PINS Date: Apr 15, 2011 PINS Date: Jan 4, 2008 Public Review Start: Mar 9, 2012 Public Review Start: Mar 9, 2012 Approval Date: Nov 8, 2013 Approval Date: Aug 1, 2012 ANSI/AAMI/IEC 80601-2-30-2009/C1-2009,Medical electrical ANSI/AAMI/IEC 60601-2-50-2009 (R2014),Medical electrical equipment - Part 2-30: Particular requirements for basic safety and equipment - Part 2-50: Particular requirements for the basic safety and essential performance of automated type non-invasive essential performance of infant phototherapy equipment (reaffirmation sphygmomanometers (supplement to ANSI/AAMI/IEC 80601-2-30 of ANSI/AAMI/IEC 60601-2-50-2009) -2009) PINS Date: PINS Date: Oct 30, 2009 Public Review Start: Apr 18, 2014 Public Review Start: Jul 24, 2009 Approval Date: Dec 16, 2014 Approval Date: Dec 10, 2009 ANSI/AAMI/IEC 62304, Ed.1-2006 (R2013),Medical device software - ANSI/AAMI/IEC 80601-2-35-2011,Medical electric equipment – Part 2 Software life cycle processes (reaffirmation of ANSI/AAMI/IEC 62304, -35: Particular requirements for basic safety and essential performance Ed.1-2006) of heating devices using blankets, pads or mattresses and intended for PINS Date: heating in medical use (new standard) Public Review Start: Oct 14, 2011 PINS Date: Nov 19, 2010 Approval Date: Jun 14, 2013 Public Review Start: Jan 21, 2011 Approval Date: Mar 8, 2011 ANSI/AAMI/IEC 62366-1-2015,Medical devices - Application of usability Engineering to medical devices (identical national adoption of ANSI/AAMI/IEC 80601-2-58-2008,Medical electrical equipment - Part 2 IEC 62366-1 (in development) and revision of ANSI/AAMI/IEC 62366 -58: Particular requirements for basic safety and essential performance -2007 (R2013)) of lens removal devices and vitrectomy device for ophthalmic surgery PINS Date: (identical national adoption of IEC 80601-2-58) Public Review Start: Jan 3, 2014 PINS Date: Nov 2, 2007 Approval Date: Feb 23, 2015 Public Review Start: Nov 2, 2007 Approval Date: Dec 10, 2008 ANSI/AAMI/IEC 62366-2007/A1-2014,Medical devices - Application of usability engineering to medical devices - Amendment 1 (identical ANSI/AAMI/IEC 80601-2-58-2014,Medical electrical equipment - Part 2 national adoption of IEC 62366:2007/A1 (in development)) -58: Particular requirements for the basic safety and essential PINS Date: Aug 17, 2012 performance of lens removal devices and vitrectomy devices for Public Review Start: Oct 19, 2012 ophthalmic surgery (identical national adoption of IEC 80601-2-58) Approval Date: Jan 7, 2014 PINS Date: May 24, 2013 Public Review Start: Jun 21, 2013 Approval Date: Sep 10, 2014 ANSI/AAMI/IEC 80001-1-2010,Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities (identical national adoption of IEC 80001-1) ANSI/AAMI/ISO 10079-1-2003 (R2014),Medical suction equipment – PINS Date: Aug 7, 2009 Part 1: Electrically powered suction equipment – Safety requirements Public Review Start: Aug 21, 2009 (reaffirmation of ANSI/ASTM ISO 10079-1-2003) Approval Date: Oct 6, 2010 PINS Date: Public Review Start: Dec 20, 2013 Approval Date: Feb 4, 2014 ANSI/AAMI/IEC 80601-2-30-2009,Medical electrical equipment - Part 2 -30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ANSI/AAMI/ISO 10079-2-2002 (R2014),Medical suction equipment – (identical national adoption of IEC 80601-2-30 (current revision project Part 2: Manually powered suction equipment (reaffirmation of in IEC) and revision of ANSI/AAMI SP10-2002, ANSI/AAMI SP10 ANSI/ASTM ISO 10079-2-2002) -2002/A1-2003, and ANSI/AAMI SP10-2002/A2-2006) PINS Date: PINS Date: May 18, 2007 Public Review Start: Dec 20, 2013 Public Review Start: Nov 30, 2007 Approval Date: Feb 4, 2014 Approval Date: Jul 24, 2009 ANSI/AAMI/ISO 10079-3-2002 (R2014),Medical suction equipment – Part 3: Suction equipment powered from a vacuum or pressure source (reaffirmation of ANSI/ASTM ISO 10079-3-2002) PINS Date: Public Review Start: Dec 20, 2013 Approval Date: Feb 4, 2014 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 5 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 10651-4-2002 (R2014),Lung ventilators – Part 4: ANSI/AAMI/ISO 10993-15-2000 (R2011),Biological evaluation of Particular requirements for operator-powered resuscitators medical devices - Part 15: Identification and quantification of (reaffirmation of ANSI/ASTM/ISO 10651-4-2002) degradation products from metals and alloys (reaffirmation of PINS Date: ANSI/AAMI/ISO 10993-15-2000 (R2006)) Public Review Start: Dec 20, 2013 PINS Date: Approval Date: Feb 4, 2014 Public Review Start: Jun 17, 2011 Approval Date: Nov 16, 2011 ANSI/AAMI/ISO 10651-5-2006 (R2014),Lung ventilators for medical use – Particular requirements for basic safety and essential performance – ANSI/AAMI/ISO 10993-16-2010 (R2014),Biological evaluation of Part 5: Gas-powered emergency resuscitators (reaffirmation of medical devices - Part 16: Toxicokinetic study design for degradation ANSI/ASTM/ISO 10651-5-2006) products and leachables (reaffirmation of ANSI/AAMI/ISO 10993-16 PINS Date: -2010) Public Review Start: Dec 20, 2013 PINS Date: Approval Date: Feb 4, 2014 Public Review Start: Jul 11, 2014 Approval Date: Oct 8, 2014 ANSI/AAMI/ISO 10993-1-2009 (R2013),Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management ANSI/AAMI/ISO 10993-17-2002 (R2012),Biological evaluation of process (reaffirmation of ANSI/AAMI/ISO 10993-1-2009) medical devices - Part 17: Establishment of allowable limits for PINS Date: leachable substances (reaffirmation of ANSI/AAMI/ISO 10993-17-2002 Public Review Start: Aug 16, 2013 (R2008)) Approval Date: Dec 2, 2013 PINS Date: Public Review Start: Aug 17, 2012 Approval Date: Nov 30, 2012 ANSI/AAMI/ISO 10993-10:2010 (R2014),Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (reaffirmation of ANSI/AAMI/ISO 10993-10:2010) ANSI/AAMI/ISO 10993-2-2006 (R2010),Biological evaluation of medical PINS Date: devices - Part 2: Animal welfare requirements (reaffirmation of Public Review Start: Jul 11, 2014 ANSI/AAMI/ISO 10993-2-2006) Approval Date: Oct 8, 2014 PINS Date: Public Review Start: Jul 23, 2010 Approval Date: Dec 14, 2010 ANSI/AAMI/ISO 10993-11-2006 (R2014),Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (reaffirmation of ANSI/AAMI/ISO 10993-11-2006 (R2010)) ANSI/AAMI/ISO 10993-2-2006 (R2014),Biological evaluation of medical PINS Date: devices - Part 2: Animal welfare requirements (reaffirmation of Public Review Start: Apr 18, 2014 ANSI/AAMI/ISO 10993-2-2006 (R2010)) Approval Date: Sep 24, 2014 PINS Date: Public Review Start: Jul 11, 2014 Approval Date: Oct 8, 2014 ANSI/AAMI/ISO 10993-12-2012,Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (identical national adoption of ISO 10993-12 and revision of ANSI/AAMI/ISO 10993-3-2014,Biological evaluation of medical devices ANSI/AAMI/ISO 10993-12-2007) - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity PINS Date: Aug 7, 2009 (identical national adoption of and revision of ANSI/AAMI/ISO 10993-3 Public Review Start: Jun 25, 2010 -2003 (R2013)) Approval Date: Jul 26, 2012 PINS Date: Feb 9, 2007 Public Review Start: Mar 8, 2013 Approval Date: Aug 14, 2014 ANSI/AAMI/ISO 10993-13-2010 (R2014),Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (reaffirmation of ANSI/AAMI/ISO 10993-4-Amd1-2006 (R2009),Biological evaluation of ANSI/AAMI/ISO 10993-13-2010) medical devices - Part 4: Selection of test for interactions with blood PINS Date: (Amendment 1) (reaffirmation of ANSI/AAMI/ISO 10993-4-Amd1-2006) Public Review Start: Jul 11, 2014 PINS Date: Approval Date: Oct 8, 2014 Public Review Start: Oct 10, 2008 Approval Date: Mar 5, 2009 ANSI/AAMI/ISO 10993-14-2001 (R2011),Biological evaluation of medical devices - Part 14: Identification and quantification of ANSI/AAMI/ISO 10993-4:2002 (R2013),Biological evaluation of medical degradation products from ceramics (reaffirmation of ANSI/AAMI/ISO devices - Part 4: Selection of tests for interactions with blood 10993-14-2001 (R2006)) (reaffirmation of ANSI/AAMI/ISO 10993-4-2002 (R2009)) PINS Date: PINS Date: Public Review Start: Jun 17, 2011 Public Review Start: Aug 16, 2013 Approval Date: Nov 16, 2011 Approval Date: Nov 26, 2013 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 6 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 10993-5-2009 (R2014),Biological evaluation of medical ANSI/AAMI/ISO 11137-3-2006 (R2010),Sterilization of health care devices - Part 5: Tests for in vitro cytotoxicity (reaffirmation of products - Radiation - Part 3: Guidance on dosimetric aspects ANSI/AAMI/ISO 10993-5-2009) (reaffirmation of ANSI/AAMI/ISO 11137-3-2006) PINS Date: PINS Date: Public Review Start: Aug 16, 2013 Public Review Start: Jul 3, 2009 Approval Date: Feb 6, 2014 Approval Date: Apr 20, 2010 ANSI/AAMI/ISO 10993-6-2007 (R2014),Biological evaluation of medical ANSI/AAMI/ISO 11138-1-2006 (R2010),Sterilization of health care devices - Part 6: Tests for local effects after implantation (reaffirmation products - Biological indicators - Part 1: General requirements of ANSI/AAMI/ISO 10993-6-2007 (R2010)) (reaffirmation of ANSI/AAMI/ISO 11138-1-2006) PINS Date: PINS Date: Public Review Start: Apr 18, 2014 Public Review Start: Sep 11, 2009 Approval Date: Sep 24, 2014 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 10993-7-2008 (R2012),Biological evaluation of medical ANSI/AAMI/ISO 11138-2-2006 (R2010),Sterilization of health care devices - Part 7: Ethylene oxide sterilization residuals (reaffirmation of products - Biological indicators - Part 2: Biological indicators for ANSI/AAMI/ISO 10993-7-2008) ethylene oxide sterilization processes (reaffirmation of ANSI/AAMI/ISO PINS Date: 11138-2-2006) Public Review Start: Dec 16, 2011 PINS Date: Approval Date: Jun 1, 2012 Public Review Start: Sep 11, 2009 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 10993-9-1999 (R2014),Biological evaluation of medical devices - Part 9: Framework for identification and quantification of ANSI/AAMI/ISO 11138-3-2006 (R2010),Sterilization of health care potential degradation products (reaffirmation of ANSI/AAMI/ISO 10993 products - Biological indicators - Part 3: Biological indicators for moist -9-2009) heat sterilization processes (reaffirmation of ANSI/AAMI/ISO 11138-3 PINS Date: -2006) Public Review Start: Apr 18, 2014 PINS Date: Approval Date: Sep 23, 2014 Public Review Start: Sep 11, 2009 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 11135-2015,Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and ANSI/AAMI/ISO 11138-4-2006 (R2010),Sterilization of health care routine control of a sterilization process for medical devices (identical products - Biological indicators - Part 4: Biological indicators for dry national adoption of ISO 11135:2014 and revision of ANSI/AAMI/ISO heat sterilization processes (reaffirmation of ANSI/AAMI/ISO 11138-4 11135-1-2007) -2006) PINS Date: PINS Date: Public Review Start: Jul 25, 2014 Public Review Start: Sep 11, 2009 Approval Date: Jul 27, 2015 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 11137-1-2006 (R2010),Sterilization of health care ANSI/AAMI/ISO 11138-5-2006 (R2010),Sterilization of health care products - Radiation - Part 1: Requirements for the development, products - Biological indicators - Part 5: Biological indicators for low- validation and routine control of a sterilization process for medical temperature steam and formaldehyde sterilization processes devices (reaffirmation of ANSI/AAMI/ISO 11137-1-2006) (reaffirmation of ANSI/AAMI/ISO 11138-5-2006) PINS Date: PINS Date: Public Review Start: Jul 3, 2009 Public Review Start: Sep 11, 2009 Approval Date: Apr 20, 2010 Approval Date: Apr 22, 2010 ANSI/AAMI/ISO 11137-1:2006/Amd 1-2013,Sterilization of health care ANSI/AAMI/ISO 11140-1-2014,Sterilization of health care products - products - Radiation - Part 1: Requirements for development, Chemical indicators - Part 1: General requirements (identical national validation and routine control of a sterilization process for medical adoption of ISO/DIS 11140-1 and revision of ANSI/AAMI/ISO 11140-1 devices - Amendment 1 (identical national adoption of ISO 11137 -2005 (R2010)) -1:2006/DAmd 1) PINS Date: Dec 2, 2011 PINS Date: Jul 20, 2012 Public Review Start: Sep 7, 2012 Public Review Start: Oct 26, 2012 Approval Date: Sep 10, 2014 Approval Date: Dec 30, 2013 ANSI/AAMI/ISO 11140-3-2007 (R2012),Sterilization of health care ANSI/AAMI/ISO 11137-2, third edition-2013,Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use products - Radiation - Part 2: Establishing the sterilization dose in the Bowie and Dick-type steam penetration test (reaffirmation of (revision of ANSI/AAMI/ISO 11137-2-2012) ANSI/AAMI/ISO 11140-3-2007) PINS Date: Feb 22, 2013 PINS Date: Public Review Start: Feb 22, 2013 Public Review Start: Oct 21, 2011 Approval Date: Jul 10, 2013 Approval Date: Aug 7, 2012 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 7 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 11140-4-2007 (R2012),Sterilization of health care ANSI/AAMI/ISO 11712-2014,Anaesthetic and respiratory equipment – products - Chemical indicators - Part 4: Class 2 indicators as an supralaryngeal airways and connectors (identical national adoption of alternative to the Bowie and Dick-type test for detection of steam ISO 11712) penetration (reaffirmation of ANSI/AAMI/ISO 11140-4-2007) PINS Date: Nov 22, 2013 PINS Date: Public Review Start: Jan 3, 2014 Public Review Start: Oct 21, 2011 Approval Date: Feb 18, 2014 Approval Date: Aug 7, 2012 ANSI/AAMI/ISO 11737-1-2006 (R2011),Sterilization of medical devices ANSI/AAMI/ISO 11140-5-2007 (R2012),Sterilization of health care - Microbiological methods - Part 1: Determination of a population of products - Chemical indicators - Part 5: Class 2 indicators for Bowie and microorganisms on products (reaffirmation of ANSI/AAMI/ISO 11737-1 Dick-type air removal tests (reaffirmation of ANSI/AAMI/ISO 11140-5 -2006) -2007) PINS Date: PINS Date: Public Review Start: Jun 3, 2011 Public Review Start: Oct 21, 2011 Approval Date: Nov 16, 2011 Approval Date: Aug 7, 2012 ANSI/AAMI/ISO 11737-2-2009 (R2014),Sterilization of medical devices ANSI/AAMI/ISO 11195-2009,Gas mixers for medical use – stand-alone - Microbiological methods - Part 2: Tests of sterility performed in the gas mixers (national adoption with modifications of ISO 11195) definition, validation and maintenance of a sterilization process PINS Date: Apr 3, 2009 (reaffirmation of ANSI/AAMI/ISO 11737-2-2009) Public Review Start: May 15, 2009 PINS Date: Approval Date: Jun 30, 2009 Public Review Start: Jan 31, 2014 Approval Date: Oct 13, 2014 ANSI/AAMI/ISO 11607-1-2006 (R2010),Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ANSI/AAMI/ISO 13022-2012,Medical products containing viable barrier systems, and packaging (reaffirmation of ANSI/AAMI/ISO 11607 human cells -- Application of risk management and requirements for -1-2006) processing practices (identical national adoption of ISO 13022) PINS Date: PINS Date: May 8, 2009 Public Review Start: Aug 14, 2009 Public Review Start: Oct 29, 2010 Approval Date: Dec 14, 2010 Approval Date: Jun 18, 2012 ANSI/AAMI/ISO 11607-1:2006, A1-2014,Amendment 1 to ANSI/AAMI/ISO 13408-1-2008 (R2011),Aseptic processing of health ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized care products - Part 1: General requirements (reaffirmation of medical devices - Part 1: Requirements for materials, sterile barrier ANSI/AAMI/ISO 13408-1-2008) systems, and packaging (addenda to ANSI/AAMI/ISO 11607-1:2006) PINS Date: PINS Date: Public Review Start: Aug 5, 2011 Public Review Start: Apr 19, 2013 Approval Date: Dec 14, 2011 Approval Date: Sep 10, 2014 ANSI/AAMI/ISO 13408-1-2008/A1-2013,Aseptic processing of health ANSI/AAMI/ISO 11607-2-2006 (R2010),Packaging for terminally care products - Part 1: General requirements - Amendment 1 (addenda sterilized medical devices - Part 2: Validation requirements for forming, to ANSI/AAMI/ISO 13408-1-2008) sealing and assembly processes (reaffirmation of ANSI/AAMI/ISO PINS Date: Jul 22, 2011 11607-2-2006) Public Review Start: Oct 14, 2011 PINS Date: Approval Date: Mar 27, 2013 Public Review Start: Aug 14, 2009 Approval Date: Dec 14, 2010 ANSI/AAMI/ISO 13408-2-2003 (R2013),Aseptic processing of health care products - Part 2: Filtration (reaffirmation of ANSI/AAMI/ISO ANSI/AAMI/ISO 11607-2:2006, A1-2014,Amendment 1 to 13408-2-2003) ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized PINS Date: medical devices - Part 2: Validation requirements for forming, sealing Public Review Start: Sep 6, 2013 and assembly processes (addenda to ANSI/AAMI/ISO 11607-2:2006) Approval Date: Dec 4, 2013 PINS Date: Public Review Start: Apr 19, 2013 ANSI/AAMI/ISO 13408-3-2012 (R2015),Aseptic processing of health Approval Date: Sep 10, 2014 care products - Part 3: Lyophilization (reaffirmation of ANSI/AAMI/ISO 13408-3-2006 (R2012)) ANSI/AAMI/ISO 11658-2012,Cardiovascular implants and PINS Date: extracorporeal systems - Blood/tissue contact surface modifications for Public Review Start: Feb 13, 2015 extracorporeal perfusion systems (identical national adoption of ISO Approval Date: Jul 13, 2015 11658) PINS Date: Oct 23, 2009 Public Review Start: May 6, 2011 Approval Date: Aug 20, 2012 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 8 Approved American National Standards The data in this document is reported as of Monday, September 28, 2015 ANSI/AAMI/ISO 13408-4-2005 (R2012),Aseptic processing of health ANSI/AAMI/ISO 14155-1-2003 (R2008),Clinical investigation of medical care products - Part 4: Clean-in-place technologies (reaffirmation of devices for human subjects - Part 1: General requirements ANSI/AAMI/ISO 13408-4-2005) (reaffirmation of ANSI/AAMI/ISO 14155-1-2003) PINS Date: PINS Date: Public Review Start: Aug 17, 2012 Public Review Start: Sep 19, 2008 Approval Date: Nov 30, 2012 Approval Date: Dec 19, 2008 ANSI/AAMI/ISO 13408-4-2005 (R2014),Aseptic processing of health ANSI/AAMI/ISO 14155-2-2003 (R2008),Clinical investigation of medical care products - Part 4: Clean-in-place technologies (reaffirmation of devices for human subjects - Part 2: Clinical investigation plans ANSI/AAMI/ISO 13408-4-2005 (R2012)) (reaffirmation of ANSI/AAMI/ISO 14155-2-2003) PINS Date: PINS Date: Public Review Start: Jan 31, 2014 Public Review Start: Sep 19, 2008 Approval Date: Oct 13, 2014 Approval Date: Dec 19, 2008 ANSI/AAMI/ISO 13408-5-2012 (R2015),Aseptic processing of health ANSI/AAMI/ISO 14155-2010,Clinical investigation of medical devices care products - Part 5: Sterilization in place (reaffirmation of for human subjects - Good clinical practice (identical national ANSI/AAMI/ISO 13408-5-2006 (R2012)) adoption of ISO 14155) PINS Date: PINS Date: Jan 23, 2009 Public Review Start: May 1, 2015 Public Review Start: Nov 13, 2009 Approval Date: Aug 3, 2015 Approval Date: Dec 30, 2010 ANSI/AAMI/ISO 13408-6-2005 (R2013),Aseptic processing of health ANSI/AAMI/ISO 14160-2011,Sterilization of health care products - care products - Part 6: Isolator systems (reaffirmation of Liquid chemical sterilizing agents for single-use medical devices utilizing ANSI/AAMI/ISO 13408-6-2005) animal tissues and their derivatives - Requirements for PINS Date: characterization, development, validation and routine control of a Public Review Start: Aug 16, 2013 sterilization process for medical devices (identical national adoption of Approval Date: Nov 26, 2013 ISO 14160 and revision of ANSI/AAMI/ISO 14160-1998 (R2008)) PINS Date: Jan 23, 2009 Public Review Start: Apr 24, 2009 ANSI/AAMI/ISO 13408-6-2005/A1-2013,Aseptic processing of health Approval Date: Dec 5, 2011 care products - Part 6: Isolator systems - Amendment 1 (addenda to ANSI/AAMI/ISO 13408-6-2005) PINS Date: Sep 23, 2011 ANSI/AAMI/ISO 14161-2009 (R2014),Sterilization of health care Public Review Start: May 4, 2012 products - Biological indicators - Guidance for the selection, use and Approval Date: Mar 11, 2013 interpretation of results (reaffirmation of ANSI/AAMI/ISO 14161-2009) PINS Date: Public Review Start: Nov 8, 2013 ANSI/AAMI/ISO 13408-7-2012,Aseptic processing of health care Approval Date: Apr 2, 2014 products - Part 7: Alternative processes for atypical medical devices and combination products (identical national adoption of ISO 13408-7 (under development)) ANSI/AAMI/ISO 14408-2009,Tracheal tubes designed for laser surgery PINS Date: – requirements for marking and accompanying information (identical Public Review Start: Mar 18, 2011 national adoption of ISO 14408:2005) Approval Date: Jul 26, 2012 PINS Date: Jul 18, 2008 Public Review Start: Mar 6, 2009 Approval Date: Apr 21, 2009 ANSI/AAMI/ISO 13485-2003 (R2013),Medical devices - Quality management systems - Requirements for regulatory purposes (reaffirmation of ANSI/AAMI/ISO 13485-2003 (R2009)) ANSI/AAMI/ISO 14708-3-2008 (R2011),Implants for surgery - Active PINS Date: implantable medical devices - Part 3: Implantable neurostimulators Public Review Start: Aug 30, 2013 (reaffirmation of ANSI/AAMI/ISO 14708-3-2008) Approval Date: Oct 23, 2013 PINS Date: Public Review Start: Jun 3, 2011 Approval Date: Nov 16, 2011 ANSI/AAMI/ISO 14117-2012,Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac ANSI/AAMI/ISO 14708-4-2008 (R2011),Implants for surgery - Active resynchronization devices (identical national adoption of ISO 14117 implantable medical devices - Part 4: Implantable infusion pumps and revision of ANSI/AAMI PC69-2007) (reaffirmation of ANSI/AAMI/ISO 14708-4-2008) PINS Date: Jul 23, 2010 PINS Date: Public Review Start: Jun 29, 2012 Public Review Start: Jun 17, 2011 Approval Date: Nov 30, 2012 Approval Date: Nov 16, 2011 Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 9

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information, archived issues of ANSI's Standards Action in (PDF) format are available at (www.ansi.org/standardsaction). Questions national adoption of ISO 81060-2:20xx and revision of ANSI/AAMI/ISO ANSI/ASME B46.1-2009, Surface Texture, Surface Roughness, Waviness and Lay (revision
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