Epidural Anaesthesia Kit

34 Pages·2013·0.29 MB·English

浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd

Epidural Anaesthesia Kit

Document No：SJ-CE -10 Version ：1.0

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Date

2006.Sep.26

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Validation Date： 2006/09/18
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd
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Releasing No： Control Status：

Content

1． Instruction----------------------------------------------------SJ-CE-10-01
2． Basic requirements checking matrix------------SJ-CE-10-02
3． Description---------------------------------------------------SJ-CE-10-03
4． Production process------------------------------------------SJ-CE-10-04
5． Risk Analysis -----------------------------------------------SJ-CE-10-05
6． Clinical study------------------------------------------------SJ-CE-10-06
7． Clinical report --------------------------------------------- SJ-CE-10-07
8． Biocompatibility report------------------------------SJ-CE-10-08
9． Label and term---------------------------------------------- SJ-CE-10-09
10. Package qualification------------------------------------------SJ-CE-10-10
11. Sterilization report----------------------------------------------SJ-CE-10-11
12. Qualification notice-------------------------------------------- SJ-CE-10-12
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd

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Title：Content Page1 1 of 1
Introduction
1About company
Zhejiang Sujia Medical Device Co., Ltd (Sujia) is the first joint stock enterprise in medical
devise industry of Zhejiang. It started as Sujia Medical Devise Factory in 1992. Now it is
located at 168 Zhenxing Road, Jiaxing Economic Developing Zone, covering an area of
40196sqm, with a construction area of 31944sqm. The garden makes up 37.8% of the plant.
It is a modern and garden-style medical device manufacturer. Sujia specializes in
disposable devices. It has gotten the certificates of ISO9001:2000 and ISO13485:2000.

2 About products
2.1The anaesthesia kit manufactured by our company consists of disposable L.O.R
syringe,disposable epidural needle,disposable filter, catheter connector,and epidural cathether
packed in a PVC tray and dialysis paper. It boasts fine biocompatibility and low sensitization.
Sterilized for safe use.
Specification：16G, 18G
2.2 Pass the tests of in vitro cytotoxiciy, delayed contact sensitization, intracutaneous toxicity,
and pyrogen reaction（Jinnan Medical Device Quality Monitoring and Inspection Center）
conducted all the tests, see Inspection report for details）. No negative effect to human body. No
calcium formed during the usage
3 Intented application
Used for human epidural anesthesia by puncturing and injecting the anesthesia fluid. This kit is
for local anesthesia and stay in human body below 60 mins in clinical treatment.
4 Contradictions
a. Disposable, reuse is not allowed
b. Used as artificial trachea of patient, the staying time is no longer than 1hour.
c. Used products may cause potential pollution, dispose as the instruction or relating rules and
law.
d. Not for use if the package is broken.
5 Classification
The kit is for clinical local anaesthesia, and the parts stay in human body no more than 1 hour. In
accordance with the EU MDD 93/42/EEC Appendix Ⅸ,it falls into the class of Iib,rule6 of
short-term used medical device.
6 Qualification
The assessment of product qualification abides by the EU MDD 93/42/EEC. Company apply for
CE mark as the procedure of Appendix (cid:31) and(cid:31).
7 Reference
MDD93/42/EEC Appendix Ⅸ、Ⅶ、Ⅴ.
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd
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Title: Introduction Page 1 of 1
Document No: SJ-CE-10-01 Version: 1.0
EU Medical Device Coordinator and International Standards List
No Document No Version Document
1 93/42/EEC 1993.6.14 EU MDD
Quality System—Medical Device—regulation
2 ISO13485 2003
requirements
EN14644-1 1999
3 Guideline for Cleaning Workshop
EN14644-2 2000
EN ISO14971:2000 2000
4 Risk Analysis for Medical Device
+A1:2003 2003
Sterilization of Medical device： ETO
5 EN550 1994
Confirmation and Regular Control
6 EN556-1 2001 Requirements for Sterilization
Graphical symbols used in the labelling of
7 EN980 1996.5
Medical Device
Terms, marks and information of Medical
8 EN1041 1994.8
Devices
Sterilization of Medical Device—Microbe
9 EN1174-1 1996.2 assessment for product—Part I: Basic
requirements
Sterilization of Medical Device—Microbe
10 EN1174-2 1996.11 pollution assessment for product—Part I：
Instruction
Sterilization of Medical Device—Measure of
11 EN1174-3 1996.11 Bacteria—Part III: Instruction on bacteria
calculation
ISO594-1 1986
12 Standard Luer Connector
ISO594-2 1998
Sterilization of Medical Device—Assessment
of microbe of product—Part I: General
ISO11737-1 2006 Requirement
13
ISO11737-2 1998 Sterilization of Medical Device—Assessment
of microbe pollution of product—Part II:
Application guideline
Assessment of Microbiology for Medical
14 ISO10993-1 1997
Device—Part I: Instruction for Test alternatives
15 ISO10993-4: 2002 Hemolysis Test
Biological Assessment of Medical
16 ISO10993-5 1993
Device—Part V: In Vitro Cytotoxicity
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd
17 ISO10993-7 1995 Residual ETO

Title: Basic Requirements Checking List Page1 of 2
Document No.：SJ-CE-10-02 Version：1 .0

Biological Assessment of Medical
18 ISO10993-10 1995.3.15 Device—Part X：Irritation and Sensitization
tests
19 ISO10993-11 1995 Systematic Toxicity
YY0321.1
20 YY0321.2 2000 Disposable Anaesthesia Kit
YY0321.3
Packing material and System of Sterilized
21 EN868-1 1997.2 Medical Device—Part I：General Requirement
and Test Method
Sterilized Medical Packing Material
22 ISO11607 2003
Requirement
23 ISO7886-1 1993 Disposable Sterilized Syringe
ISO9626:1991 1991
24 Medical Grade Stainless Steel Needle
+Amd1:2002 2002
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd

Title: Basic Requirements Checking List Page2 of 2
Document No.：SJ-CE-10-02 Version：1 .0
Basic Requirements Checking List

A- Manufacturers
Essential Requirements Standards Place
N/A Compliance
1. The devices must be designed and manufactured in
such a way that, when used under the conditions and for
EN1782:19 Test report
the purposes intended, they will not compromise the
98 No.Y20030106
clinical condition or the safety of patients, or the safety
MDD93/42/ 06 QA
and health of users or, where applicable, other persons, A
EEC Quality Manual Dept
provided that any risks which may be associated with
ISO GYJ2005
their use constitute acceptable risks when weighed
13485:2003 No.063
against the benefits to the patient and are compatible
with a high level of protection of health and safety.
2. The solutions adopted by the manufacturer for the
design and construction of the devices must conform to
safety principles, taking account of the generally EN1782:19
acknowledged state of the art. In selecting the most 98
appropriate solutions, the manufacturer must apply the MDD93/42/ Risk Analysis
following principles in the following order. EEC SJ-CE-10-05 QA
A
-eliminate or reduce risks as far as possible (inherently ISO Clinical Data Dept
safe design and construction.) 14971:2000 SJ-CE-10-06
-where appropriate take adequate protection measures ISO
including alarms if necessary. 13485:2003
-inform users of the residual due to any defection of the
protection measures adopted.
3. The devices must achieve the performances intended Test report
by the manufacturer and be designed, manufactured and No.Y20030106
General
packaged in such a way that they are suitable for one or EN868-1 06 Quality
A engineer
more of the functions referred to in Article(a), as Manual
office
specified by the manufacturer. GYJ2005
No.063
4.The characteristics and performances referred to in Preclinical
Sections 1,2 and 3 must not be adversely affected to Study
such a degree that the clinical conditions and safety of SJ-CE-10-06
General
the patients and, where applicable, of other persons are Sterilization
A EN550 engineer
compromised during the lifetime of the devices as validation
office
indicated by the manufacturer, when the device is report
subjected to the stresses which can occur during normal SB-7.5.2.1
conditions of use.
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd
5. The devices must be designed, manufactured and
Package
packed in such a way that their characteristics and
qualified General
performances during their intended use will not be EN868-1-19
A certification engineer
adversely affected during transport and storage taking 98
SJ-CE-10-10 office
account of the instructions and provided by the

manufacturer.

Title：Basic Requirement Checking List Page 1 of 11
Document No.：SJ-CE-10-02 Version：1 .0

A- Manufacturers
Essential Requirements Standards Place
N/A Compliance
6. Any undesirable side effect must constitute an Risk Analysis
General
acceptable risk when weighed against the performances ISO14971:2 SJ-CE-10-05
A engineer
intended. 003 Clinical Data
office
SJ-CE-10-07
II.REQUIREMENTS REGARDING DESIGN AND
CONSTRUCION
7.Chemical, physical and biological properties
Test report
7.1 The devices must be designed and manufactured in
No.Y20030106
such a way as to guarantee the characteristics and
06 General
performances referred to in Section 1 on the General EN30993
A Biocompatabilit engineer
requirements’. Particular attention must be paid to:
y office
The choice of materials used, particularly as regards to
GYJ2005
cellular toxicity and, where appropriate, flammability.
No.063
The compatibility between the materials used and
biological tissues, cells and body fluids, taking account
of the intended use of the device.
7.2 The devices must be designed, manufactured and
packed in such a way as to minimize the risk posed by Test report
contaminants and residues to the persons involved in No.Y20030106 General
the transport, storage and use of the devices and to the A EN868-1 06 engineer
patients, taking account of the intended purpose of the GYJ2005 No office
product. Particular attention must be paid to the tissues 063
exposed and to the duration and frequency of exposure.
7.3 Devices must be designed, manufactured and
packed in such a way that they can be used safely with
the materials, substances and gases with which they Test report
enter into contact their normal use or during routine No.Y20030106
procedures; if the devices are intended to administer 06
EN30993
medicinal products they must be designed and A Biocompatabilit

manufactured in such a way as to be compatible with y
the medicinal products concerned according to the GYJ2005
provisions and restrictions governing these products No.063
and that their performance is maintained in accordance
intended use.
7.4 Where a device incorporates, as an integral part, N/A
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd
substance which, if used separately, may be considered
to be a medicinal product as defined in Article of
Directive 65/65/EEC and which is liable to act upon
the body with action ancillary to that of the device, the
safety, quality and usefulness of the substance must be
verified,

Title：Basic Requirement Checking List Page 2 of 11
Document No.：SJ-CE-10-02 Version：1 .0

A- Manufacturers
Essential Requirements Standards Place
N/A Compliance
taking account of the intended purpose of the device, by
analogy with the appropriate methods specified in
Directive 75/318/EEC.
7.5 The device must be designed manufactured in such Test report
EN30993
a way as to a minimum the risks posed by substances A No.Y2003010606

from the device. GYJ2005 No.063
7.6 Devices must be designed and manufactured in such
a way as to reduce, as much as possible, risks posed by
the unintentional ingress of substances into the device N/A
taking into the device and the nature of the environment
in which is intended to be used.
8. Infection and microbial contamination
8.1 The devices and manufacturing processes must be Test report
designed in such a way as to eliminate or reduce as far No.Y20030106 General
EN30993
as possible the risk of infection to the patient, and third A 06 engineer

parties. The design must allow easy handing and, where GYJ2005 office
necessary, minimize contamination of the device the No.063
patient or vice during use.
8.2 Tissues of animal origin must originate from
animals that have been subjected to veterinary controls
and surveillance adapted to the intended use of the
tissues.
Notified bodies shall retain information the
geographical origin of the animals.
Processing, preservation, testing and handing of tissues, N/A
cells and substances of animals origin must be carried
out so s to provide optima; security. In particular safety
with regard to viruses and other transferable agents
must be addressed by implementation of validated
methods of elimination or viral inactivation the course
of the manufacturing process.
8.3 Devices delivered in a sterile state must be Sterilization General
EN550
designed, manufactured and packed in a non-reusable A Validation engineer
EN868-1
pack and /or according to appropriate procedures to SB-7.5.2.1 office
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd
ensure that they are sterile when placed on the market
and remain sterile, under he storage and transport
conditions lard down, until the protective packaging is
damaged or opened.
8.4 Devices delivered in a sterile state must have been Sterilization General
EN550
manufactured and sterilized by an appropriate, A Validation engineer
EN868-1
validated method. SB-7.5.2.1 office

Title：Basic Requirement Checking List Page 3 of 11
Document No.：SJ-CE-10-02 Version：1 .0
A- Manufacturers
Essential Requirements Standards Place
N/A Compliance
8.5 Devices intended to be sterilized must be The Enviroment
manufactured in appropriately controlled (e.g. ISO13485:2003 Controling System General
environmental) conditions. A ISO14644-1/-2 verification report engineer
DREN1632 office
No（2002）（326）
8.6 Packaging systems for non-sterile devices
must keep the product without deterioration at the
level of cleanliness stipulated and, if the devices
are to be sterilized prior to use, minimize the risk N/A
of microbial contamination; the packaging system
must be suitable taking account of the method of
sterilization indicated by the manufacturer.
8.7 The packaging and/or label of the device must
distinguish between identical or similar products N/A
sold in both sterile and non-sterile condition
9. Construction and environmental properties
9.1 If the device is intended for use in
Test report
combination with other devices or equipment, the
A No.Y2003010606
whole combination, including the connection
GYJ2005 No.063
system must be indicated on the label or in the
instructions for use.
9.2 Devices must be designed and manufactured
in such a way as to remove or minimize as far as
possible:
-the risk of injury, in connection with their
physical features including the volume/ pressures
Test report
ratio, dimensional and where appropriate
A No.Y2003010606
ergonomic features.
GYJ2005 No.063
-risks connected with reasonably foreseeable
environmental conditions, such as magnetic
fields, external electrical influences, electrostatic
discharge, pressure, temperature or variations in
pressure and acceleration.
-the risks of reciprocal interference with other
浙江苏嘉医疗器械股份有限公司 Zhejiang Sujia Medical Device Co.,Ltd
devices normally used in the investigations or the
treatment given
-risks arising where maintenance or calibration
are not possible (as with implants), from aging of
materials used or loss of accuracy of any
mechanism.
9.3 Devices must be designed and manufactured N/A
in such a way as to minimize the risks of fire or
explosion during normal use and in single fault
condition.
_____________________________________________________________________________
Title：Basic Requirement Checking List Page 4 of 11
Document No.：SJ-CE-10-02 Version：1 .0

A- Manufacturers
Essential Requirements Standards Place
N/A Compliance
Particular attention must paid to devices whose
intended use includes exposure to flammable
N/A
substances or to substances which could cause
combustion.
10. Devices with measuring function
10.1 Devices with a measuring function must be
designed and manufactured in such a way as to provide
sufficient accuracy and stability within appropriate N/A
limits of accuracy and taking account of the intended
purpose of the device. The limits of accuracy must be
indicated by the manufacturer.
10.2 The measurement, monitoring and display scale
must be designed in line with ergonomic principles, N/A
taking account of the intended purpose of the device.
10.3 The measurements made by devices with a
measuring function must be expressed in legal units
N/A
conforming to the provisions of Council Directive
80/181/EEC
11.Protection against radiation
11.1 General
11.1.1 Devices shall be designed and manufactured in
such a way that exposure of patients, users and other
N/A
persons to radiation shall be reduced as far as possible
compatible with the intended purpose, whilst not
restricting the application of appropriate specified
levels for therapeutic and diagnostic purposes.
11.2 Intended radiation
11.2.1 Where devices are designed to emit hazardous
levels of radiation necessary for a specific medical N/A
purpose the benefit of which is considered to outweigh
the risks inherent in the emission, it must be possible