एम एच ड 15/ ट

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1 भ रत य म नक ब य र (उपभ म मल, ख द एव स वर ज नक वतरण म त लय, भ रत सरक र) (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म गर, नई दल ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : स दभर दन क पक प रचलन म मस द एम एच ड 15/ ट तकन क स म त एम एच ड 15 प न व ल क न म इल क म डकल, ड य स टक इम ज ग और र डय थ र प उपकरण वषय स म त एमएचड 15 क सभ सदस य क च कत स उपकरण एवम अस पत ल आय जन वभ ग प रषद अन य सभ च रखन व ल य मह दय/मह दय, न ल खत ल ख सल ह 1. ल ख सख य : एम एच ड 15 (11491) आएस/आईस -1-1 : 2015 [ ] श षर क : च कत स य व त उपस कर ड जटल एक स-र इम ज ग उपकरण क लक ण भ ग 1-1 डट क टव टम दक त क नध र रण र डय फक इम ज ग म य डट क टर क प य इन म नक मस द क अवल कन कर और अपन सम म तय यह बत त ए भ ज क अ तत य द य म नक र य म नक क प म क शत ह ज य त इन पर अमल करन म आपक वस ए अथव क र ब र म क य क ठन इय आ सकत ह सम म तय य द क ई ह त क प य अगल प पर दय गय प म अध हस त क र क उप र ल खत पत पर भ ज द सम म तय भ जन क अ तम त थ :

2 भ रत य म नक ब य र (उपभ म मल, ख द एव स वर ज नक वतरण म त लय, भ रत सरक र) (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म गर, नई दल ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : य द क ई सम म त नह ह त ह अथव सम म त म क वल भ ष स ब ध ट ई त उपर ल ख क यथ वत अ तम प द दय ज य ग य द क ई सम म त तकन क क त क ई त वषय स म त क अध यक क पर मशर स अथव उनक इच छ पर आग क क यर व ह क लय वषय स म त क भ ज ज न क ब द ल ख क अ तम प द दय ज य ग धन यव द भवद य स ल क : उपर ( क श बच न ) व ज नक ई एव मख (एम एच ड ) ई म ल 1) sempal@bis.org.in 2)mhd@bis.org.in फ न :

3 भ रत य म नक ब य र (उपभ म मल, ख द एव स वर ज नक वतरण म त लय, भ रत सरक र) (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म गर, नई दल ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : DRAFTS IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHD 15 DOCUMENT DESPATCH ADVICE Ref Date MHD 15/ T /05/2017 ADDRESSED TO: 1. All members of Electromedical, 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: 1. DOC NO: MHD 15(11491) IS/IEC : 2015 [ ] TITLE : Medical Electrical Equipment Characteristics of digital X-ray imaging devices Part 1-1 Determination of the detective quantum efficiency Detectors used in radiographic imaging 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: 31/05/2017 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, (Prakash Bachani) Scientist E & Head (MHD) Encl: As above 1) sempal@bis.org.in 2) mhd@bis.org.in

4 Draft for Comments only (Not to be reproduced without permission of BIS or used as standard) Last date of receipt of comments is [Doc No.: MHD 15 (11491)] IS/IEC : 2015 भ रत य म नक मस द च कत स य वद त उपस कर ड जटल एक स-र इम ज ग उपकरण क ल ण भ ग 1-1 डट क टव क व टम द त क नध र रण र डय ग फक इम ज ग म प य प डट क टर Draft Indian Standard Medical Electrical Equipment Characteristics of digital X-ray imaging devices Part 1-1 Determination of the detective quantum efficiency Detectors used in radiographic imaging ICS BIS 2017 MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI May 2017 Price Group

5 Draft for Comments only (Not to be reproduced without permission of BIS or used as standard) Last date of receipt of comments is [Doc No.: MHD 15 (00000)] IS/IEC : 2015 Draft Indian Standard Medical Electrical Equipment Characteristics of digital X-ray imaging devices Part 1-1 Determination of the detective quantum efficiency Detectors used in radiographic imaging Electromedical, Diagnostic Imaging and Radiotherapy Equipment Sectional Committee, MHD 15 NATIONAL FOREWORD This Indian Standard (Part 1-1) which is identical with IEC : 2015 Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging issued by the International Electrotechnical Commission (IEC) to be adopted by the Bureau of Indian Standards on the recommendation of Electromedical, Diagnostic Imaging and Radiotherapy Equipment Sectional Committee, and approval of the Medical Equipment and Hospital Planning Division Council. This standard published in various parts. Other parts of the standard are: Part 1-2 Part 1-3 Determination of the detective quantum efficiency Detectors used in mammography Determination of the detective quantum efficiency Detectors used in dynamic imaging Only the English language text of IEC Standard has been retained while adopting it in this standard and as such the page numbers given here are not the same as in the IEC 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 ; and b) Comma (,) has been used as the decimal marker while in Indian Standards, the current practice is to use a point (.) as a decimal marker.

6 In this adopted standard, reference appears to the following 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 Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots IEC TR : 2004 Medical electrical equipment Glossary of defined terms IS/IEC : 2005 Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots IS/IEC/TR : 2004 Medical electrical equipment Glossary of defined terms Identical with IEC : 2005 Identical The 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 Title IEC : 2005 Medical diagnostic X-ray equipment Radiation conditions for use in the determination of characteristics. In reporting the result of a test or analysis made in accordance to this standard, is to be rounded off, it shall be done in accordance with IS 2 : 1960 Rules for rounding off numerical values (revised). 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 sempal@bis.org.in, mhd@bis.org.in ; hmhd@bis.org.in;

7 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(11491) [IS/IEC : 2015] TITLE: Medical electrical equipment Characteristics of digital X-ray imaging devices : Part 1-1 Determination of the detective quantum efficiency Detectors used in radiographic imaging LAST DATE OF COMMENTS: NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Sub clause /Para/table/Fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

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