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Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

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है”ह”ह

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]

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

B U R E A U O F I N D I A N S T A N D A R D SMANAK BHAVAN, 9 BAHADUR 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 electricalequipment — 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 Standardson the recommendation of the Electromedical Equipment Sectional Committee and approval of the MedicalEquipment and Hospital Planning Division Council.

This Particular Standard concerns the safety of multifunction patient monitoring equipment. It supplementsthe General Standard IS 13450 (Part 1) : 2008 ‘Medical electrical equipment: Part 1 General requirements forthe basic safety and essential performance (first revision)’. The requirements of this Particular Standard takepriority over those of the General Standard.

A general guidance for the requirements of this Particular Standard is included in Annex AA. It is consideredthat knowledge of the reasons for these requirements will not only facilitate the proper application of thestandard but will, in due course, expedite any revision necessitated by the changes in clinical practice or asa result of developments in technology. However, this annex does not form part of the requirements of thisstandard.

The text of IEC Standard has been approved as suitable for publication as an Indian Standard withoutdeviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention isparticularly 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 Standardsalso exist. The corresponding Indian Standards which are to be substituted in their places are listed belowalong with their degree of equivalence for the editions indicated:

(Continued on third cover)

International Standard

IEC 60601-1 : 19881) Medical electricalequipment — Par t 1: Generalrequirements for safety

IEC 60529 : 1989 Degrees of protectionprovided by enclosures (IP code)

IEC 60601-1-4 : 19962) Medicalelectrical equipment — Part 1: Generalrequirements for safety — Section 4:Collateral standard : Programmableelectrical medical systems

Corresponding Indian Standard

IS 13450 (Part 1) : 2008 Medicalelectrical equipment: Part 1 Generalrequirements for the basic safety andessential performance (first revision)

IS 12063 : 1987 Classification ofdegrees of protection provided byenclosures of electrical equipment

IS 13450 (Part 1/Sec 4) : 2009 Medicalelectrical equipment: Part 1 Generalrequirements for safety, Section 4Collateral standard: Programmableelectrical medical systems

Degree of Equivalence

Technically Equivalent

do

do

1)Since revised in 2005.2)Since revised in 2000.

IS 13450 (Part 2/Sec 49) : 2009IEC 60601-2-49 : 2001

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Indian Standard

MEDICAL ELECTRICAL EQUIPMENTPART 2 PARTICULAR REQUIREMENTS FOR THE SAFETY

Section 49 Multifunction Patient Monitoring Equipment

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NATIONAL ANNEX A(National Foreword)

A-1 BIS CERTIFICATION MARKINGThe product may also be marked with the Standard Mark.

A-1.1 The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act,1986 and the Rules and Regulations made thereunder. The details of conditions under which the licence forthe use of Standard Mark may be granted to manufacturers or producers may be obtained from the Bureauof Indian Standards.

IS 13450 (Part 2/Sec 49) : 2009IEC 60601-2-49 : 2001

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(Continued from second cover)

The technical committee responsible for the preparation of this standard has reviewed the provisions of thefollowing International Standards referred in this adopted standard and has decided that they are acceptablefor use in conjunction with this standard:

International Standard Title

IEC/TR3 60513 : 1994 Fundamental aspects of safety standards for medical electrical equipment

IEC 60601-1-2 : 19931) Medical electrical equipment — Part 1: General requirements for safety —Section 2: Collateral standard: Electromagnetic compatibility — Requirementsand tests

The standard also makes a reference to the BIS Certification Marking of the product, details of which isgiven in National Annex A.

For the purpose of deciding whether a particular requirement of this standard is complied with, the finalvalue, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordancewith IS 2 : 1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places retainedin the rounded off value should be the same as that of the specified value in this standard.

1)Since revised in 2007.

Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promote

harmonious development of the activities of standardization, marking and quality certification of

goods and attending to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of the these publications may be reproduced in

any form without the prior permission in writing of BIS. This does not preclude the free use, in the

course of implementing the standard, of necessary details, such as symbols and sizes, type or grade

designations. Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are

also reviewed periodically; a standard alongwith amendments is reaffirmed when such review indicates

that no changes are needed; if the review indicates that changes are needed, it is taken up for revision.

Users of Indian Standards should ascertain that they are in possession of the latest amendments or

edition by referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed from Doc No.: MHR 15 (0072).

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

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