एम एच ड 15/ ट 70, 71 & 72

Transcription

1 भ रत य म नक य र (उपभ म मल, एव स व ज नक वतरण म र लय, भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : य पक प रचलन म मस द तकन क स म त एम एच ड 15 प न व ल क न म स दभ एम एच ड 15/ ट 70, 71 & 72 दन क इल र म डकल और ड य न टक इम ज ग और र डय थ र प उपकरण वषय स म त एमएचड 15 क सभ सद य क च क स उपकरण एवम अ पत ल आय जन वभ ग प रषद अ य सभ च रखन व ल रय मह दय/मह दय, न न ल खत रल ख सल न ह 1. रल ख स य एम एच ड 15 (0415) आएस (भ ग 2/अन भ ग 50) : ---- /आईस : 2009 श ष क : च क स य व य त उ प क र - भ ग 2 ब नय द स र क लए वश ष आव यकत ऐ और आव यक क य न प दन : अन भ ग 50 शश फ ट थ र प उपकरण 2. रल ख स य एम एच ड 15 (0416) आएस (भ ग 2/अन भ ग 63)/आईस : 2012 श ष क : च क स य व य त उ प क र - भ ग 2 ब नय द स र क लए वश ष आव यकत ऐ और आव यक क य न प दन: अन भ ग 63 द त ए र ओरल ए स-र उपकरण 3. रल ख स य एम एच ड 15 (0417) आएस (भ ग 2/अन भ ग 65) : -----/आईस : 2012 श ष क : च क स य व य त उ प क र - भ ग 2 ब नय द स र क लए वश ष आव यकत ऐ और आव यक क य न प दन: अन भ ग 65 इ र ओरल ए स-र उपकरण

2 भ रत य म नक य र (उपभ म मल, एव स व ज नक वतरण म र लय, भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : क य इन म नक मस द क अवल कन कर और अपन स म तय यह बत त ह ए भ ज क अ तत य द य म नक र र य म नक क प म रक शत ह ज य त इन पर अमल करन म आपक यवस ए अथव क र ब र म य क ठन इय आ सकत ह स म तय य द क ई ह त क य अगल प ट पर दय गय पर म अध ह त र क उप र ल खत पत पर भ ज द स म तय भ जन क अ तम त थ : य द क ई स म त र त नह ह त ह अथव स म त म क वल भ ष स ब ध र ट ह ई त उपर त रल ख क यथ वत अ तम प द दय ज य ग य द क ई स म त तकन क रक त क ह ई त वषय स म त क अ य क पर मश स अथव उनक इ छ पर आग क क य व ह क लय वषय स म त क भ ज ज न क ब द रल ख क अ तम प द दय ज य ग ध यव द स ल नक : उपर त भवद य (ड क अरव ल) व नक एफ एव रमख (एम एच ड ) ई म ल 1) sempal@bis.org.in 2) mhd@bis.org.in फ न :

3 भ रत य म नक य र (उपभ म मल, एव स व ज नक वतरण म र लय, भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : DRAFTS IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE Ref Date MHD 15/ T- 70, 71 & 72 25/06/2015 TECHNICAL COMMITTEE: MHD 15 ADDRESSED TO: 1. All members of Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee, MHD All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Madam/Sir(s), Please find enclosed the following documents: DOC NO: MHD 15(0415) [IS (Part 2/Sec 50) : ----/IEC : 2009] TITLE : Medical electrical equipment - Part 2 Particular for the basic safety and essential performance : Section 50 Infant phototherapy equipment DOC NO: MHD 15(0416) [IS (Part 2/Sec 63) : ----/IEC : 2012] TITLE : Medical Electrical Equipment - Part 2 Particular for the basic safety and essential performance: Section 63 Dental extra-oral X-ray equipment DOC NO: MHD 15(0417) [IS (Part 2/Sec 65) : --- /IEC : 2012] TITLE : Medical electrical equipment - Part 2 Particular for the basic safety and essential performance of X-ray equipment: Section 65 Dental intra-oral X-ray equipment Kindly examine the draft standards and forward your views stating any difficulties, which you are likely to experience in your business or profession, if these are finally adopted as National Standard. Last date for comments: 24/09/2015

4 भ रत य म नक य र (उपभ म मल, एव स व ज नक वतरण म र लय, भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : 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 (D K Agrawal) Scientist F & Head (MHD) 1) sempal@bis.org.in 2) mhd@bis.org.in Telefax:

5 Draft for Comments only Doc No.: MHD 15 (0415) IS (Part 2/Sec 50) : /IEC : 2009 भ रत य म नक मस द च क स य व य त उप कर भ ग 2 ब नय द स र क लए वश ष आव यकत ऐ और आव यक क य न प दन अन भ ग 50 शश फ ट थ र प उपकरण DRAFT Indian Standard MEDICAL ELECTRICAL EQUIPMENT PART 2 : PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE Section 50 Infant phototherapy equipment ICS BIS 2015 B U R E A U O F I N D I A N S T A N D A R D S MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI June 2015 Price Group

6 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft for Comments only Doc No: MHD 15(0415) IS (Part 2/Sec 50) : /IEC : 2009 DRAFT Indian Standard MEDICAL ELECTRICAL EQUIPMENT PART 2 PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE Section 50 Infant phototherapy equipment Last date of receipt of comments is 24/09/2015 Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee, MHD 15 NATIONAL FOREWORD This draft Indian Standard (Part 2/Sec 50) is identical with IEC : 2009 Medical electrical equipment 2-50 : Particular for the basic safety and essential performance of infant phototherapy equipment issued by the International Electrotechnical Commission (IEC) to be adopted by the Bureau of Indian Standards on the recommendation of the Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The minimum safety specified in this particular standard are considered to provide for a practical degree of safety in the operation of INFANT PHOTHERAPY EQUIPMENT. This particular standard amends and supplements IS (Part 1) : 2008/IEC : 2005 Medical electrical equipment Part 1: General for basic safety and essential performance, hereinafter referred to as the general standard. The are followed by specifications for the relevant tests. A general guidance and rationale for the of this particular standard are given in Annex AA. It is considered that knowledge of the reasons for these will not only facilitate the proper application of this particular standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the of this standard.

7 The text of 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 appear 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 places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence IEC Electrical apparatus for explosive gas atmospheres Part 0: General IEC Electrical apparatus for explosive gas atmospheres Part 2: Pressurized enclosures p IEC Electrical apparatus for explosive gas atmospheres Part 5: Powder filling q IEC Electrical apparatus for explosive gas atmospheres Part 6: Oilimmersion o IEC , Miniature fuses Part 1: Definitions for miniature fuses and general for miniature fuse-links IEC Appliance couplers for household and similar general purposes Part IS/IEC : 2007 Electrical apparatus for explosive gas atmospheres : Part 0 General Requirements IS/IEC : 2007 Explosive protection by pressurized enclosure "p" IS/IEC : 2007 Explosive atmospheres: Part 5 Equipment protection by powder filling "q" IS/IEC : 2007 Explosive Atmospheres: Part 6 Equipment Protection by Oil Immersion "0 IS/IEC : 2006 Miniature fuses : Part 1 Definitions for miniature fuses an general for miniature fuse-links IS/IEC : 2001 Appliance couplers for household and similar general purposes: Part 1 General IEC : 2007 IEC : 2007 IEC : 2007 IEC : 2007 IEC : 2006 IEC : 2001

8 1: General International Standards Corresponding Indian Standards Degree of Equivalence IEC : ) Degrees of protection provided by enclosures (IP Code) IEC ) Medical electrical equipment Part 1-2: General for safety Collateral standard: Electromagnetic compatibility Requirements and tests IEC Medical electrical equipment Part 1-3: General for basic safety and essential performance. Collateral standard: Radiation protection in diagnostic X-ray equipment IEC : ) Automatic electrical controls for household and similar use Part 1: General IEC : 2000 Switches for appliances Part 1: General IEC Mechanical safety of cathode ray tubes ISO Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General IS/IEC : 2001 Degrees of protection provided by enclosures (IP CODE) IS (Part 1/Sec 2) : 2012 Medical electrical equipment - Part 1: General for the safety : Section 2 Collateral standard - Electromagnetic compatibility - Requirements and tests IS (Part 1/Sec 3) : 2014 Medical Electrical Equipment - Part 1: General requirement for safety :Section 3 Collateral Standard: General requirement for radiation protection in diagnostic X-ray Equipment IS/IEC : 1999 Automatic electrical controls for household and similar use : part 1 General Requirements IS/IEC : 2000 Switches for appliances : Part 1 General IS/IEC : 2003 Mechanical Safety Of Cathode Ray Tubes IS/ISO : 2001 Mechanical Vibration - Measurement and Evaluation of Human Exposure to Hand Transmitted Vibration - Part 1 : General Requirements IEC : 2001 IEC : 2007 IEC : 2008 IS/IEC : 1999 Identical do do 1) Since revised in ) Since revised in ) Since revised in 2013.

9 International Standards Corresponding Indian Standards Degree of Equivalence ISO (all parts), Biological evaluation of medical devices IS 12572(Part 1) : 1994 Biological 1: Guidance on selection of tests (first revision) IS 12572(Part 2) : 1994 Biological 2: Animal welfare IS 12572(Part 13) : 1994 Biological 13: Tests for genotoxicity, carcinogenicity and reproductive toxicity IS 12572(Part 14) : 1994 Biological 14: Selection of tests for interactions with blood IS/ISO : 2009 Biological 5: Tests for invitro cytotoxicity [To be published] ISO : 2007 Biological evaluation of medical devices-part 6: Tests for local effects after implantation [To be published] ISO : 2008 Biological evaluation of medical devices-part 7: Ethylene oxide Sterilization residuals [To be published] ISO : 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization [To be published] IS/ISO : 2006 Biological evaluation of medical devices- Part 11 Tests for systemic toxicity [To be published] IS/ISO : 2012 Biological 12: Sample preparation [To be published] ISO (Part 1) : 1992 ISO (Part 2) : 1992 ISO (Part 3) : 1992 ISO : 1992 ISO : 2009 ISO : 2007 ISO : 2008 ISO : 2010 ISO : 2006 ISO : 2012

10 International Standards Corresponding Indian Standards Degree of Equivalence ISO : 2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General ISO : 2009, Quantities and units Part 1: General IS/ISO : 2005 Biological 18: Chemical characterization of materials [To be published] IS/ISO : 2006 Biological 20: Principles and methods for immunotoxicology testing of medical devices [To be published] IS/ ISO : 2012 Medical Devices Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements (First Revision ) IS/ISO : 2009 Quantities and Units part 1 General ISO : 2005 ISO : 2006 Identical do The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard Title IEC : 2001 IEC : 2007 IEC IEC IEC IEC IEC : 2007 IEC :2003 Audio, video and similar electronic apparatus Safety Environmental testing Part 2-2: Tests Test B: Dry heat Plugs and socket-outlets for domestic and similar general use standardized in member countries of IEC Electrical insulation Thermal classification Primary batteries Part 4: Safety of lithium batteries Method for the determination of the proof and the comparative tracking indices of solid insulating materials Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V Part 1: General Rubber insulated cables Rated voltages up to and including 450/750 V Part 1: General

11 International Standard Title IEC AC motor capacitors Part 1: General Performance, testing and rating Safety Guide for installation and operation IEC : 2010 Household and similar electrical appliances Safety Part 1: IEC General Electrical installations of buildings Part 4-41: Protection for safety Protection against electric shock IEC : 2005 Fixed capacitors for use in electronic equipment Part 14: Sectional Specification: Fixed capacitors for electromagnetic interference suppression and connection to the supply mains IEC IEC IEC IEC IEC Graphical symbols for use on equipment. Basic and safety principles for man-machine interface, marking and identification Identification of equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system Basic and safety principles for man-machine interface, marking and identification Actuating principles Medical electrical equipment Part 1-6: General for safety Collateral standard: Usability Medical electrical equipment Part 1-8: General for safety - Collateral standard: General, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC : 2007 Insulation coordination for equipment within low-voltage systems Part 1: Principles, and tests IEC Fire hazard testing Part 11-10: Test flames 50 W horizontal and vertical flame test methods IEC : 2007 Safety of laser products Part 1: Equipment classification and IEC : 2009 Winding wires Test methods Part 3: Mechanical properties IEC : 2008 Winding wires Test methods Part 5: Electrical properties IEC : 1996 Winding wires Test methods Part 6: Thermal properties IEC Plugs and socket-outlets for household and similar purposes - Part 1: General Requirements IEC : 2001 Information technology equipment Safety Part 1: General IEC :2000 Switches for appliances Part 1: General

12 International Standard Title IEC Safety transformers, power supply units and similar Part 2: Particular for separating transformers for general use IEC Electroacoustics Sound level meters Part 1: Specifications IEC Electroacoustics Sound level meters Part 2: Pattern evaluation tests IEC IEC Mechanical safety of cathode ray tubes Secondary cells and batteries containing alkaline or other nonacid electrolytes Safety for portable sealed secondary cells, and for batteries made from them, for use in portable applications IEC : 2006 Medical device software Software lifecycle processes ISO 780 Packaging Pictorial marking for handling of goods ISO 1853 Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity ISO 2878 Rubber, vulcanized Antistatic and conductive products Determination of electrical resistance ISO ) ISO 3746 Rubber, vulcanized Antistatic and conductive products for hospital use Electrical resistance limits Acoustics Determination of sound power levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane ISO : 2002 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs in workplaces and public areas Graphical symbols for use on equipment Collection of symbols ISO 7010 : 2011 Graphical symbols Safety colours and safety signs ISO 7000-DB : ) ISO ISO : 2009 Registered safety signs Acoustics Determination of sound power levels of noise sources using sound intensity Measurement at discrete points Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products ISO : 2010 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices 1) ISO 2882 was withdrawn on I February 2005 and no replacement has been identified. 2) DB refers to the joint ISO-IEC on-line data base.

13 International Standard Title ISO : 2001 Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics ISO : 2000 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys ISO : 2010 Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables ISO : 2012 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances ISO : 2006 Biological evaluation of medical devices -- Part 19: Physicochemical, morphological and topographical characterization of materials ISO/TR : 2015 Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO ISO : 2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO : 2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO : 2008 ISO : 2007 Safety of machinery Safety distances to prevent hazard zones being reached by the upper and lower limbs Medical devices Application of risk management to medical devices ISO : 2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO Rubber General procedures for preparing and conditioning test pieces for physical test methods The standard also makes a reference to the BIS Certification Marking of the product. Details of which is given in National Annex A. For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2 : 1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

14 A-1 BIS CERTIFICATION MARKING NATIONAL ANNEX A (National Foreword) The 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 for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards. Note: The technical content of the draft is not available on website. For details please contact: Head (MHD) Bureau of Indian Standards Manak Bhawan 9 Bahadur Shah Zafar Marg New Delhi hmhd@bis.org.in, mhd@bis.org.in

15 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 15 (0415)[ )[IS (Part 2/Sec 50) : ----/IEC : 2009] TITLE : Medical electrical equipment - Part 2 Particular for the basic safety and essential performance: Section 50 Infant phototherapy equipment. LAST DATE OF COMMENTS: 24/09/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

16 Draft for Comments only Doc No.: MHD 15 (0416) IS (Part 2/Sec 63) : /IEC : 2012 भ रत य म नक मस द च क स य व य त उप कर भ ग 2 ब नय द स र क लए वश ष आव यकत ऐ और आव यक क य न प दन अन भ ग 63 द त ए र ओरल ए स-र उपकरण DRAFT Indian Standard MEDICAL ELECTRICAL EQUIPMENT PART 2 : PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE Section 63 Dental extra-oral X-ray equipment ICS BIS 2015 B U R E A U O F I N D I A N S T A N D A R D S MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI June 2015 Price Group

17 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft for Comments only Doc No: MHD 15(0416) IS (Part 2/Sec 63) : /IEC : 2012 DRAFT Indian Standard MEDICAL ELECTRICAL EQUIPMENT PART 2 PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE Section 63 Dental extra-oral X-ray equipment Last date of receipt of comments is 24/09/2015 Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee, MHD 15 NATIONAL FOREWORD This draft Indian Standard (Part 2/Sec 63) is identical with IEC : 2009 Medical electrical equipment 2-63 : Particular for the basic safety and essential performance of dental extra-oral X-ray equipment issued by the International Electrotechnical Commission (IEC) to be adopted by the Bureau of Indian Standards on the recommendation of the Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The minimum safety specified in this particular standard are considered to provide for a practical degree of safety in the operation of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.. The minimum safety for DENTAL INTRA-ORAL X-RAY EQUIPMENT are specified in a separate particular standard IS (Pat 2)/Sec 65)/IEC to simplify and improve the readability This particular standard amends and supplements IS (Part 1) : 2008/IEC : 2005 Medical electrical equipment Part 1: General for basic safety and essential performance, hereinafter referred to as the general standard. Requirements particular to DENTAL X-RAY-EQUIPMENT and all addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard.

18 This particular standard establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE for ME EQUIPMENT for EXTRA-ORAL DENTAL RADIOGRAPHY. The text of 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 appear 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 places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence IEC Electrical apparatus for explosive gas atmospheres Part 0: General IEC Electrical apparatus for explosive gas atmospheres Part 2: Pressurized enclosures p IEC Electrical apparatus for explosive gas atmospheres Part 5: Powder filling q IEC Electrical apparatus for explosive gas atmospheres Part 6: Oilimmersion o IEC , Miniature fuses Part 1: Definitions for miniature fuses and general for miniature fuse-links IS/IEC : 2007 Electrical apparatus for explosive gas atmospheres : Part 0 General Requirements IS/IEC : 2007 Explosive protection by pressurized enclosure "p" IS/IEC : 2007 Explosive atmospheres: Part 5 Equipment protection by powder filling "q" IS/IEC : 2007 Explosive Atmospheres: Part 6 Equipment Protection by Oil Immersion "0 IS/IEC : 2006 Miniature fuses : Part 1 Definitions for miniature fuses an general for miniature fuse-links IEC : 2007 IEC : 2007 IEC : 2007 IEC : 2007 IEC : 2006

19 International Standards Corresponding Indian Standards Degree of Equivalence IEC Appliance couplers for household and similar general purposes Part 1: General IEC 60336, Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots IEC : ) Degrees of protection provided by enclosures (IP Code) IEC : ) Medical electrical equipment Part 1-2: General for safety Collateral standard: Electromagnetic compatibility Requirements and tests IEC : 2008 Medical electrical equipment Part 1-3: General for basic safety and essential performance. Collateral standard: Radiation protection in diagnostic X-ray equipment IEC : 2008, Medical electrical equipment Part 2-29: Particular for the basic safety and essential performance of radiotherapy simulators IS/IEC : 2001 Appliance couplers for household and similar general purposes: Part 1 General Medical electrical equipment - X-Ray tube assemblies for Medical diagnostic - Characteristic of focal spots IS/IEC : 2001 Degrees of protection provided by enclosures (IP CODE) IS (Part 1/Sec 2) : 2012 Medical electrical equipment - Part 1: General for the safety : Section 2 Collateral standard - Electromagnetic compatibility - Requirements and tests IS (Part 1/Sec 3) : 2014 Medical Electrical Equipment - Part 1: General requirement for safety :Section 3 Collateral Standard: General requirement for radiation protection in diagnostic X-ray Equipment IS (Part 2/Sec 29) : -- Medical Electrical Equipment - Part 2 Particular for the basic safety and essential performance: Section 29 Radiotherapy simulators (First Revision) [MHD 15(0364)] IEC : 2001 IEC : 2005 IEC : 2001 IEC : 2007 Identical do 1) Since revised in ) Since revised in 2014.

20 International Standards Corresponding Indian Standards Degree of Equivalence IEC : 2009, Medical electrical equipment Part 2-54: Particular for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC : ) Automatic electrical controls for household and similar use Part 1: General IEC/TR 60788:2004, Medical electrical equipment Glossary of defined terms IEC : 2000 Switches for appliances Part 1: General IEC Mechanical safety of cathode ray tubes ISO Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General ISO (all parts), Biological evaluation of medical devices 1) Since revised in IS (Part 2/Sec 54) : Medical Electrical Equipment - Part 2-54: Particular requirement for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Under publication) IS/IEC : 1999 Automatic electrical controls for household and similar use : part 1 General Requirements IS/ IEC/TR 60788:2004 Medical electrical equipment Glossary of defined terms IS/IEC : 2000 Switches for appliances : Part 1 General IS/IEC : 2003 Mechanical Safety Of Cathode Ray Tubes IS/ISO : 2001 Mechanical Vibration - Measurement and Evaluation of Human Exposure to Hand Transmitted Vibration - Part 1 : General Requirements IS 12572(Part 1) : 1994 Biological 1: Guidance on selection of tests (first revision) IS 12572(Part 2) : 1994 Biological 2: Animal welfare IS 12572(Part 13) : 1994 Biological 13: Tests for genotoxicity, carcinogenicity and reproductive toxicity Identical IS/IEC : 1999 Identical Identical do do ISO (Part 1) : 1992 ISO (Part 2) : 1992 ISO (Part 3) : 1992

21 International Standards Corresponding Indian Standards Degree of Equivalence ISO (all parts), Biological evaluation of medical devices IS 12572(Part 14) : 1994 Biological 14: Selection of tests for interactions with blood IS/ISO : 2009 Biological 5: Tests for invitro cytotoxicity [To be published] ISO : 2007 Biological evaluation of medical devices-part 6: Tests for local effects after implantation [To be published] ISO : 2008 Biological evaluation of medical devices-part 7: Ethylene oxide Sterilization residuals [To be published] ISO : 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization [To be published] IS/ISO : 2006 Biological evaluation of medical devices- Part 11 Tests for systemic toxicity [To be published] IS/ISO : 2012 Biological 12: Sample preparation [To be published] IS/ISO : 2005 Biological 18: Chemical characterization of materials [To be published] ISO : 1992 ISO : 2009 ISO : 2007 ISO : 2008 ISO : 2010 ISO : 2006 ISO : 2012 ISO : 2005

22 International Standards Corresponding Indian Standards Degree of Equivalence ISO : 2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General ISO : 2009, Quantities and units Part 1: General IS/ISO : 2006 Biological 20: Principles and methods for immunotoxicology testing of medical devices [To be published] IS/ ISO : 2012 Medical Devices Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements (First Revision ) IS/ISO : 2009 Quantities and Units part 1 General ISO : 2006 Identical do The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard Title IEC : 2001 IEC : 2007 IEC IEC IEC IEC IEC : 2007 IEC :2003 IEC Audio, video and similar electronic apparatus Safety Environmental testing Part 2-2: Tests Test B: Dry heat Plugs and socket-outlets for domestic and similar general use standardized in member countries of IEC Electrical insulation Thermal classification Primary batteries Part 4: Safety of lithium batteries Method for the determination of the proof and the comparative tracking indices of solid insulating materials Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V Part 1: General Rubber insulated cables Rated voltages up to and including 450/750 V Part 1: General AC motor capacitors Part 1: General Performance, testing and rating Safety Guide for installation and operation IEC : 2010 Household and similar electrical appliances Safety Part 1: General

23 International Standard Title IEC Electrical installations of buildings Part 4-41: Protection for safety Protection against electric shock IEC : 2005 Fixed capacitors for use in electronic equipment Part 14: Sectional Specification: Fixed capacitors for electromagnetic interference suppression and connection to the supply mains IEC IEC IEC IEC IEC Graphical symbols for use on equipment. Basic and safety principles for man-machine interface, marking and identification Identification of equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system Basic and safety principles for man-machine interface, marking and identification Actuating principles Medical electrical equipment Part 1-6: General for safety Collateral standard: Usability Medical electrical equipment Part 1-8: General for safety - Collateral standard: General, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC : 2007 Insulation coordination for equipment within low-voltage systems Part 1: Principles, and tests IEC Fire hazard testing Part 11-10: Test flames 50 W horizontal and vertical flame test methods IEC : 2007 Safety of laser products Part 1: Equipment classification and IEC : 2009 Winding wires Test methods Part 3: Mechanical properties IEC : 2008 Winding wires Test methods Part 5: Electrical properties IEC : 1996 Winding wires Test methods Part 6: Thermal properties IEC Plugs and socket-outlets for household and similar purposes - Part 1: General Requirements IEC : 2001 Information technology equipment Safety Part 1: General IEC :2000 Switches for appliances Part 1: General IEC Safety transformers, power supply units and similar Part 2: Particular for separating transformers for general use IEC Electroacoustics Sound level meters Part 1: Specifications IEC Electroacoustics Sound level meters Part 2: Pattern evaluation tests IEC/PAS : 2007 Medical electrical equipment Radiation dose documentation IEC Part 1: Equipment for radiography and radioscopy Mechanical safety of cathode ray tubes

24 International Standard Title IEC Secondary cells and batteries containing alkaline or other nonacid electrolytes Safety for portable sealed secondary cells, and for batteries made from them, for use in portable applications IEC : 2006 Medical device software Software lifecycle processes ISO 780 Packaging Pictorial marking for handling of goods ISO 1853 Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity ISO 2878 Rubber, vulcanized Antistatic and conductive products Determination of electrical resistance ISO ) Rubber, vulcanized Antistatic and conductive products for ISO 3746 hospital use Electrical resistance limits Acoustics Determination of sound power levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane ISO : 2002 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs in workplaces and public areas Graphical symbols for use on equipment Collection of symbols ISO 7010 : 2011 Graphical symbols Safety colours and safety signs ISO 7000-DB : ) ISO ISO : 2009 Registered safety signs Acoustics Determination of sound power levels of noise sources using sound intensity Measurement at discrete points Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products ISO : 2010 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices ISO : 2001 Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics ISO : 2000 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys ISO : 2010 Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables 1) ISO 2882 was withdrawn on 1 February 2005 and no replacement has been identified. 2) DB refers to the joint ISO-IEC on-line data base.

25 International Standard Title ISO : 2012 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances ISO : 2006 Biological evaluation of medical devices -- Part 19: Physicochemical, morphological and topographical characterization of materials ISO/TR : 2015 Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO ISO : 2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO : 2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO : 2008 Safety of machinery Safety distances to prevent hazard ISO : 2007 zones being reached by the upper and lower limbs Medical devices Application of risk management to medical devices ISO : 2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO Rubber General procedures for preparing and conditioning test pieces for physical test methods The standard also makes a reference to the BIS Certification Marking of the product. Details of which is given in National Annex A. For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2 : 1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

26 A-1 BIS CERTIFICATION MARKING NATIONAL ANNEX A (National Foreword) The 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 for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards. Note: The technical content of the draft is not available on website. For details please contact: Head (MHD) Bureau of Indian Standards Manak Bhawan 9 Bahadur Shah Zafar Marg New Delhi hmhd@bis.org.in, mhd@bis.org.in

27 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 15 (0416)[IS (Part 2/Sec 63) : ----/IEC : 2012] TITLE : Medical electrical equipment - Part 2 Particular for the basic safety and essential performance: Section 63 Dental extra-oral X-ray equipment. LAST DATE OF COMMENTS: 24/09/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

28 Draft for Comments only Doc No.: MHD 15 (0417) IS (Part 2/Sec 65) : /IEC : 2012 भ रत य म नक मस द च क स य व य त उप कर भ ग 2 ब नय द स र क लए वश ष आव यकत ऐ और आव यक क य न प दन अन भ ग 65 द त इ र ओरल ए स-र उपकरण DRAFT Indian Standard MEDICAL ELECTRICAL EQUIPMENT PART 2 : PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE Section 65 Dental intra-oral X-ray equipment ICS BIS 2015 B U R E A U O F I N D I A N S T A N D A R D S MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI June 2015 Price Group

29 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft for Comments only Doc No: MHD 15(0417) IS (Part 2/Sec 65) : /IEC : 2012 DRAFT Indian Standard MEDICAL ELECTRICAL EQUIPMENT PART 2 PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE Section 65 Dental intra-oral X-ray equipment Last date of receipt of comments is 24/09/2015 Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee, MHD 15 NATIONAL FOREWORD This draft Indian Standard (Part 2/Sec 65) is identical with IEC : 2012 Medical electrical equipment 2-65 : Particular for the basic safety and essential performance of dental intra-oral X-ray equipment issued by the International Electrotechnical Commission (IEC) to be adopted by the Bureau of Indian Standards on the recommendation of the Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The minimum safety specified in this particular standard are considered to provide for a practical degree of safety in the operation of DENTAL INTRA-ORAL X-RAY EQUIPMENT.. The minimum safety for DENTAL EXTRA-ORAL X-RAY EQUIPMENT are specified in a separate particular standard IS (Pat 2)/Sec 63)/IEC to simplify and improve the readability This particular standard amends and supplements IS (Part 1) : 2008/IEC : 2005 Medical electrical equipment Part 1: General for basic safety and essential performance, hereinafter referred to as the general standard. Requirements particular to DENTAL X-RAY-EQUIPMENT and all addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard.

30 This particular standard establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE for ME EQUIPMENT for EXTRA-ORAL DENTAL RADIOGRAPHY. The text of 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 appear 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 places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence IEC Electrical apparatus for explosive gas atmospheres Part 0: General IEC Electrical apparatus for explosive gas atmospheres Part 2: Pressurized enclosures p IEC Electrical apparatus for explosive gas atmospheres Part 5: Powder filling q IEC Electrical apparatus for explosive gas atmospheres Part 6: Oilimmersion o IEC , Miniature fuses Part 1: Definitions for miniature fuses and general for miniature fuse-links IS/IEC : 2007 Electrical apparatus for explosive gas atmospheres : Part 0 General Requirements IS/IEC : 2007 Explosive protection by pressurized enclosure "p" IS/IEC : 2007 Explosive atmospheres: Part 5 Equipment protection by powder filling "q" IS/IEC : 2007 Explosive Atmospheres: Part 6 Equipment Protection by Oil Immersion "0 IS/IEC : 2006 Miniature fuses : Part 1 Definitions for miniature fuses an general for miniature fuse-links IEC : 2007 IEC : 2007 IEC : 2007 IEC : 2007 IEC : 2006

31 International Standards Corresponding Indian Standards Degree of Equivalence IEC Appliance couplers for household and similar general purposes Part 1: General IEC 60336, Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots IEC : ) Degrees of protection provided by enclosures (IP Code) IEC : ) Medical electrical equipment Part 1-2: General for safety Collateral standard: Electromagnetic compatibility Requirements and tests IEC : 2008 Medical electrical equipment Part 1-3: General for basic safety and essential performance. Collateral standard: Radiation protection in diagnostic X-ray equipment IEC : ) Automatic electrical controls for household and similar use Part 1: General IEC/TR 60788:2004, Medical electrical equipment Glossary of defined terms IS/IEC : 2001 Appliance couplers for household and similar general purposes: Part 1 General Medical electrical equipment - X-Ray tube assemblies for Medical diagnostic - Characteristic of focal spots IS/IEC : 2001 Degrees of protection provided by enclosures (IP CODE) IS (Part 1/Sec 2) : 2012 Medical electrical equipment - Part 1: General for the safety : Section 2 Collateral standard - Electromagnetic compatibility - Requirements and tests IS (Part 1/Sec 3) : 2014 Medical Electrical Equipment - Part 1: General requirement for safety :Section 3 Collateral Standard: General requirement for radiation protection in diagnostic X-ray Equipment IS/IEC : 1999 Automatic electrical controls for household and similar use : part 1 General Requirements IS/ IEC/TR 60788:2004 Medical electrical equipment Glossary of defined terms IEC : 2001 IEC : 2005 IEC : 2001 IEC : 2007 Identical IS/IEC : 1999 Identical 1) Since revised in ) Since revised in ) Since revised in 2013.

32 International Standards Corresponding Indian Standards Degree of Equivalence IEC : 2000 Switches for appliances Part 1: General IEC Mechanical safety of cathode ray tubes IEC : 2003 ISO Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General ISO (all parts), Biological evaluation of medical devices IS/IEC : 2000 Switches for appliances : Part 1 General IS/IEC : 2003 Mechanical Safety Of Cathode Ray Tubes IS/ISO : 2003 Medical electrical equipment-characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency [Un]der print] IS/ISO : 2001 Mechanical Vibration - Measurement and Evaluation of Human Exposure to Hand Transmitted Vibration - Part 1 : General Requirements IS 12572(Part 1) : 1994 Biological 1: Guidance on selection of tests (first revision) IS 12572(Part 2) : 1994 Biological 2: Animal welfare IS 12572(Part 13) : 1994 Biological 13: Tests for genotoxicity, carcinogenicity and reproductive toxicity IS 12572(Part 14) : 1994 Biological 14: Selection of tests for interactions with blood IS/ISO : 2009 Biological 5: Tests for invitro cytotoxicity [To be published] ISO : 2007 Biological evaluation of medical devices-part 6: Tests for local effects after implantation [To be published] do Identical do do ISO (Part 1) : 1992 ISO (Part 2) : 1992 ISO (Part 3) : 1992 ISO : 1992 ISO : 2009 ISO : 2007

33 International Standards Corresponding Indian Standards Degree of Equivalence ISO (all parts), Biological evaluation of medical devices ISO : 2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General ISO : 2009, Quantities and units Part 1: General ISO : 2008 Biological evaluation of medical devices-part 7: Ethylene oxide Sterilization residuals [To be published] ISO : 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization [To be published] IS/ISO : 2006 Biological evaluation of medical devices- Part 11 Tests for systemic toxicity [To be published] IS/ISO : 2012 Biological 12: Sample preparation [To be published] IS/ISO : 2005 Biological 18: Chemical characterization of materials [To be published] IS/ISO : 2006 Biological 20: Principles and methods for immunotoxicology testing of medical devices [To be published] IS/ ISO : 2012 Medical Devices Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements (First Revision ) IS/ISO : 2009 Quantities and Units part 1 General ISO : 2008 ISO : 2010 ISO : 2006 ISO : 2012 ISO : 2005 ISO : 2006 Identical do