DRAFT IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE MHR 15/ T TECHNICAL COMMITTEE: MHR 15 ADDRESSED TO:

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1 DRAFT IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHR 15 DOCUMENT DESPATCH ADVICE Ref Date MHR 15/ T ADDRESSED TO: 1. All members of Electromedical Equipments Sectional committee(mhr 15) and Imaging and Radiotherapy Equipments Sectional Committee (MHR 18) 2. All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Madam/Sir(s), Please find enclosed the following document: DOC NO: MHR 15(0070)/IEC (2007) TITLE Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: - Requirements and tests Kindly examine this draft standard and forward your views stating any difficulties, which you are likely to experience in your business or profession, if this is finally adopted as National Standard. Last date for comments: 15/ 07/2008 Comments if any, may please be made in the format indicated and mailed to the undersigned at the above address. In case no comments are received or comments received are of editorial nature, you will kindly permit us to presume your approval for the above document as finalized. However, in case comments of technical nature are received then it may be finalized either in consultation with the Chairman, Sectional Committee or referred to the Sectional committee for further necessary action if so desired by the Chairman, Sectional Committee. Thanking you, Yours Sincerely, Encl: As above (Rahul Kumar) Scientist F & Head (MHD) 1) anurita@bis.org.in 2) mhd@bis.org.in Telefax:

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3 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard MEDICAL ELECTRICAL EQUIPMENT Part 1-2:General requirements for basic safety and essential performance Collateral standard: Requirements and tests Last date of receipt of comments is Electromedical Equipment Sectional Committee, MHR 15 NATIONAL FOREWORD (Formal clauses will be added later) This draft Indian Standard is identical with IEC (2007) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: - Requirements and tests issued by the International Electrotechnical Commission (IEC). The text of the IEC standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appears referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker 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 place are listed below along with their degree of equivalence for the editions indicated: International Standards IEC :2005 Medical electrical equipment-part 1: General requirement for safety Note: This IEC Standard has replaced 1988 version Corresponding Indian Standard IS 13450(Part1):2008 Medical electrical equipment Part 1: General requirement for safety i Degree of equivalence..contd

4 IEC :1995 (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current = 16 A per phase) IEC :1994 (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current = 16 A per phase and not subject to conditional connection IEC :1995 (EMC)- Part 4-2: Testing and Electrostatic discharge immunity test IEC :2002 (EMC) - Part 4-3 : Testing and Radiated, radio-frequency, electromagnetic field immunity test IEC :1995 (EMC) - Part 4-4: Testing and Electrical fast transient/burst immunity test IEC :1993 (EMC) - Part 4-8: Testing and Power frequency magnetic field immunity test IS (Part 3/Sec 2): 1999 (EMC) Part 3 : Limits Section 2 : Limits for harmonic current emissions (Equipment input current =16 A per phase) IS 14700(Part 3/Sec 3): 1999 Electromagnetic Compatibility (EMC) Part 3 : Limits Section 3 :Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current =16 A IS 14700(Part 4/Sec 2): 1999 (EMC) Part 4: Testing and Section 2 : Electrostatic discharge immunity test IS 14700(Part 4/Sec 3) : 2005 Electromagnetic Compatibility (EMC) Part 4: Testing and Section 3 : Radiated, Radio- Frequency, electromagnetic field immunity test IS (Part 4/Sec 4) : 1999 (EMC) Part 4 : Testing and Section 4 : Electrical fast transient/burst immunity test IS 14700(Part 4/Sec 8) : 1999 (EMC) Part 4 : Testing and Section 8 : Power frequency magnetic field immunity test ii contd

5 CISPR 11:1997 Industrial scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement CISPR 14-1: Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission CISPR 15:1996 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment CISPR 22:1997 Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement IS 6873 (Part 4): 1999 Limits and methods of measurement of radio disturbance characteristics Part 4 : Industrial, scientific and medical (ISM) Radiofrequency equipment IS 6873 (Part 2) - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission(second revision) IS 6873(Part 5) : 1999 Limits and methods of measurement of radio disturbance characteristics Part 5 : Electrical lighting and similar equipments IS 6873(Part 7): 1999 Limits and methods of measurement of radio disturbance characteristics Part 7: Information technology equipment The concerned technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards and has decided that they are acceptable for use in conjunction with this standard. International Standard IEC IEC (2005) IEC IEC IEC Title Graphical symbols for use on equipment Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (EMC) - Part 4-5: Testing and Surge immunity test (EMC) - Part 4-6: Testing and Immunity to conducted disturbances, induced by radio-frequency fields (EMC) - Part 4-11: Testing and Voltage dips, short interruptions and voltage variations immunity tests iii..contd

6 CISPR Specification for radio disturbance and immunity measuring apparatus and methods - Part 1: Radio disturbance and immunity measuring apparatus Ancillary equipment Conducted disturbances iv

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