IS 13450-2-49: Medical Electrical Equipment, Part 2: Particular Requirements for the Safety, Section 49: Multifunction Patient Monitoring Equipment

2009·2.1 MB·English

by  Bureau of Indian Standards

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IS 13450-2-49 (2009): Medical Electrical Equipment, Part 2:
Particular Requirements for the Safety, Section 49:
Multifunction Patient Monitoring Equipment [MHD 14:
Hospital Planning]
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IS 13450 (Part 2/Sec 49) : 2009
IEC 60601-2-49 : 2001
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Indian Standard
MEDICAL ELECTRICAL EQUIPMENT
PART 2 PARTICULAR REQUIREMENTS FOR THE SAFETY
Section 49 Multifunction Patient Monitoring Equipment
ICS 11.040.55
© BIS 2009
BU R E AU O F I N D I A N S TA N DA R D S
MANAK BHAVAN, 9 B AHADUR SHAH ZAFAR MARG
NEW DELHI 110002
October 2009 Price Group 13
Electromedical Equipment Sectional Committee, MHR 15
NATIONAL FOREWORD
This Indian Standard (Part 2/Sec 49) which is identical with IEC 60601-2-49 : 2001 ‘Medical electrical
equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment’
issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards
on the recommendation of the Electromedical Equipment Sectional Committee and approval of the Medical
Equipment and Hospital Planning Division Council.
This Particular Standard concerns the safety of multifunction patient monitoring equipment. It supplements
the General Standard IS 13450 (Part 1) : 2008 ‘Medical electrical equipment: Part 1 General requirements for
the basic safety and essential performance (first revision)’. The requirements of this Particular Standard take
priority over those of the General Standard.
A general guidance for the requirements of this Particular Standard is included in Annex AA. It is considered
that knowledge of the reasons for these requirements will not only facilitate the proper application of the
standard but will, in due course, expedite any revision necessitated by the changes in clinical practice or as
a result of developments in technology. However, this annex does not form part of the requirements of this
standard.
The text of IEC Standard has been approved as suitable for publication as an Indian Standard without
deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is
particularly drawn to the following:
a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as
‘Indian Standard’.
b) Comma (,) has been used as a decimal marker in the International Standard while in Indian Standards,
the current practice is to use a point (.) as the decimal marker.
In this adopted standard, reference appears to certain International Standards for which Indian Standards
also exist. The corresponding Indian Standards which are to be substituted in their places are listed below
along with their degree of equivalence for the editions indicated:
International Standard Corresponding Indian Standard Degree of Equivalence
IEC 60601-1 : 19881) Medical electrical IS 13450 (Part 1) : 2008 Medical Technically Equivalent
equipment — Part 1: General electrical equipment: Part 1 General
requirements for safety requirements for the basic safety and
essential performance (first revision)
IEC 60529 : 1989 Degrees of protection IS 12063 : 1987 Classification of do
provided by enclosures (IP code) degrees of protection provided by
enclosures of electrical equipment
IEC 60601-1-4 : 19962) Medical IS 13450 (Part 1/Sec 4) : 2009 Medical do
electrical equipment — Part 1: General electrical equipment: Part 1 General
requirements for safety — Section 4: requirements for safety, Section 4
Collateral standard : Programmable Collateral standard: Programmable
electrical medical systems electrical medical systems

1)Since revised in 2005.
2)Since revised in 2000.
(Continued on third cover)
IS 13450 (Part 2/Sec 49) : 2009
IEC 60601-2-49 : 2001
Indian Standard
MEDICAL ELECTRICAL EQUIPMENT
PART 2 PARTICULAR REQUIREMENTS FOR THE SAFETY
Section 49 Multifunction Patient Monitoring Equipment

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