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भारतीय मानक यरो (उपभो�ा मामल, खाय एव सावजिनक िवतरण मरालय, भारत सरकार) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India)

मानक भवन, 9 बहादरशाह जफर माग, नई िदली – 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi -110002 दरभाष Phones : 2323 0131 / 2323 3375 / 2323 9402 वबसाईट Website : www.bis.org.in

तकनीक� सिमित एम एच डी 12 पान वालो क नाम • अपताल क उपकरण और सिजकल िडपोजबल उपाद िवषय सिमित एमएचडी 12 क सभी सदयो को | • िचिकसा उपकरण एवम अपताल आयोजना िवभाग प�रषद | • अय सभी �िच रखन वाल | िरय महोदय/महोदया, कपया सलन अनबध म सचीबध दतावज सलन ह : कया इन मानक मसौद का अवलोकन कर और अपनी समितया यह बतात ह�ए भज िक अततः यिद य मानक रारीय मानक क �प म रकािशत हो जाय तो इन पर अमल करन म आपक यवसाए अथवा कारोबार म या किठनाइयॉ आ सकती ह | समितया यिद कोई हो तो कया अगल प� पर िदय गय पर म अधोहता�री को उप�रिलिखत पत पर भज द | समितया भजन िक अितम ितिथ : 16-01-2016

यिद कोई समित रा� नही होती ह अथवा समित म कवल भाषा सबिध रिट ह�ई तो उपरो� रलख को यथावत अितम �प द िदया जायगा | यिद कोई समित तकनीक� रकित क� ह�ई तो िवषय सिमित क अय� क परामश स अथवा उनक� इछा पर आग क� कायवाही क िलय िवषय सिमित को भज जान क बाद रलख को अितम �प द िदया जायगा | धयवाद

भवदीय

(डी क अरवाल) व�ािनक एफ एव रमख (एम एच डी)

सलनक : उपरो� ई – मल : [email protected]; [email protected]: [email protected] फोन : 011-23230910

सदभ िदनाक

एम एच डी 12/ टी – 126, 127,

128, 129, 130, 131, 132, 133, 134, 135, 136 & 137

17-11-2015

यापक प�रचलन म मसौदा

http://www.bis.org.in/

mailto:[email protected]





सलनक 1. रलख स.: एम एच डी 12 (0489) [आइ एस/आइ एस ओ 11135: 2014] [ICS 11.080.01]

शीषक: वाय दखभाल उपाद का िवसरमण — एिथलीन ऑसाइड — िचिकसा उपकरण क िलए एक िवसरमण रिरया क िवकास, सयापन और िदनचया पर िनयरण क िलए आवयकताए

2. रलख स.: एम एच डी 12 (0490)/आइ एस ओ 11140-1: 2014 [ICS 11.080.01]

शीषक : वाय दखभाल उपाद का िवसरमण — रासायिनक सकतक — भाग 1 सामाय अप�ाए 3. रलख स.: एम एच डी 12 (0491)/आइ एस ओ 11140-3: 2007] [ICS 11.080.01]

शीषक : वाय दखभाल उपाद का िवसरमण — रासायिनक सकतक — भाग 3 बॉवी और िडक रकार भाप पिनरशन परी�ण म उपयोग क िलए 19रणी19 2 सचक रणाली

4. रलख स.: एम एच डी 12 (0492)/आइ एस ओ 11140-4: 2007] [ICS 11.080.01]

शीषक : वाय दखभाल उपाद का िवसरमण — रासायिनक सकतक — भाग 4 बॉवी और िडक रकार क भाप पिनरशन परी�ण म उपयोग क िलए एक िवकप क �प म रणी 2 सकतक

5. रलख स.: एम एच डी 12 (0493)/आइ एस ओ 11140-5:2007 [ICS 11.080.01] शीषक : वाय दखभाल उपाद का िवसरमण — रासायिनक सकतक — भाग 5 बॉवी और िडक रकार क हवा अपनयन परी�ण क िलए रणी 2 सकतक

6. रलख स.: एम एच डी 12 (0494)/ आइ एस ओ 11137-1:2006 [ICS 11.080.01]

शीषक वाय दखभाल उपाद का िवसरमण — िविकरण — भाग - 1 िचिकसा उपकरण क िलए एक िवसरमण रिरया क िवकास, सयापन और िदनचया पर िनयरण क िलए आवयकताए

7. रलख स.: एम एच डी 12(0495)/आइ एस ओ 11137-2:2013 [ICS 11.080.01]

शीषक : वाय दखभाल उपाद का िवसरमण — िविकरण — भाग 2 िवसरमण क� 0 मारा (डोज) थािपत करना

8. रलख स.: एम एच डी 12 (0496) /आइ एस ओ 11137-3:2006 [ICS 11.080.01]

शीषक : वाय दखभाल उपाद का िवसरमण — िविकरण — भाग 3 डोिसमिरक पहलओ पर िदशािनद�श




9. रलख स.: एम एच डी 12 (0497) /आइ एस ओ 11737-1:2006 [ICS 11.080.01; 07.100.10]

शीषक: िचिकसा उपकरण का िवसरमण — स�मजीविव�ानी िविधया — भाग 1: उपाद पर स�मजीव क� जनसया िनधारण करना

10. रलख स.: एम एच डी 12 (0498) /आइ एस ओ 11737-2:2009 [ICS 11.080.01; 07.100.10] शीषक : िचिकसा उपकरण का िवसरमण — स�मजीविव�ानी िविधया — भाग 2: िवसरमण रिरया क�

प�रभाषा, सयापन और रखरखाव म जीवाणरिहणता टट का िनपादन 11. रलख स.: एम एच डी 12 (0499) /आइ एस ओ 11607-1:2006 [ICS 11.080.30]

शीषक : टिमनली िवसरिमत िचिकसा उपकरण क िलए पकिजग — भाग 1: सामरी, िवसरमण बाधा रणाली और पकिजग िसटम क िलए आवयकताए

12. रलख स.: एम एच डी 12 (0500) /आइ एस ओ 11607-2:2006 [ICS 11.080.30] शीषक : टिमनली िवसरिमत िचिकसा उपकरण क िलए पकिजग — भाग 2: गठन (फोिम�ग), सीिलग तथा

असबली रिरयाओ क िलए सयापन अप�ाए




DRAFTS IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHD 12 ADDRESSED TO: 1. All members of Hospital Equipment and Surgical Disposable Products Sectional Committee, MHD 12 2. All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Madam/Sir(s), Please find enclosed the documents listed in attached Annex: 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: 16/01/2016 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,

(D K Agrawal) Scientist ‘F’ & Head (MHD)

Encl: As above email: 1) [email protected] 2) [email protected]: [email protected] Telefax: 011-23230910

DOCUMENT DESPATCH ADVICE

Ref Date

MHD 12/ T- 126, 127,

128, 129, 130, 131, 132, 133, 134, 135, 136 & 137

17/11/2015







ANNEX

1. Doc No.: MHD 12(0489)/ISO 11135 : 2014 [ICS 11.080.01] TITLE: Sterilization of health care products — Ethylene oxide — Requirements for the

development, validation and routine control of a sterilization process for medical devices

2. Doc No.: MHD 12(0490)/ISO 11140-1 : 2014 [ICS 11.080.01] TITLE: Sterilization of health care products — Chemical indicators — Part 1: General

requirements

3. Doc No.: MHD 12(0491)/ISO 11140-3 : 2007 [ICS 11.080.01] TITLE: Sterilization of health care products — Chemical indicators — Part 3: Class 2

indicator systems for use in the Bowie and Dick-type steam penetration test


indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration


indicators for Bowie and Dick-type air removal tests

6. Doc No.: MHD 12(0494)/ISO 11137-1 : 2006 [ICS 11.080.01] TITLE: Sterilization of health care products — Radiation — Part 1: Requirements for

development, validation and routine control of a sterilization process for medical devices

7. Doc No.: MHD 12(0495)/ISO 11137-2 : 2013 [ICS 11.080.01] TITLE: Sterilization of health care products — Radiation — Part 2: Establishing the

sterilization dose 8. Doc No.: MHD 12(0496)/ISO 11137-3 : 2006 [ICS 11.080.01]

TITLE: Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects




9. Doc No.: MHD 12(0497)/ISO 11737-1 : 2006 [ICS 11.080.01; 07.100.10] TITLE: ‘Sterilization of medical devices -- Microbiological methods -- Part 1:

Determination of a population of microorganisms on products 10. Doc No.: MHD 12(0498)/ISO 11737-2 : 2009 [ICS 11.080.01; 07.100.10]

TITLE: Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

11. Doc No.: MHD 12(0499)/ISO 11607-1 : 2006 [ ICS 11.080.30] TITLE: Packaging for terminally sterilized medical devices

Part 1: Requirements for materials, sterile barrier systems and packaging systems

12. Doc No.: MHD 12(0500)/ISO 11607-2 : 2006 [ ICS 11.080.30] TITLE: Packaging for terminally sterilized medical devices Part 2: Validation

requirements for forming, sealing and assembly processes


Doc: MHD 12 (0489) IS/ISO 11135 : 2014

Draft for Comments only

(Not to be reproduced without permission of BIS or used as standard) Last date of receipt of comments is 16-01-2016

मसौदा भारतीय मानक वाय दखभाल उपाद� का �वसरमण — ए�थल�न ऑसाइड —

�च�कसा उपकरण� क �लए एक �वसरमण र�रया क �वकास, सयापन और �दनचया पर �नयरण क �लए आवयकताए

Draft Indian Standard STERILIZATION OF HEALTH CARE PRODUCTS — ETHYLENE OXIDE — REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE

CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

-

ICS 11.080.01

© 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 BHAWAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

November 2015 Price Group

Doc: MHD 12 (0489) IS/ISO 11135 : 2014



Hospital Equipment and Surgical Disposable Products, Sectional Committee, MHD 12

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11135 : 2014 ‘Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

A sterile medical device is one that is free of viable microorganisms. Medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see for example ISO 13485) might, prior to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.

The text of ISO 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.

Doc: MHD 12 (0489) IS/ISO 11135 : 2014

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

ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment

IS/ISO 10012 : 2003 Measurement management systems — Requirements for measurement processes and measuring equipment

Identical with

ISO 10012 :

2003

ISO 10993-7 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

IS/ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals [MHD 19 (0369) under processes]

Identical with

ISO 10993-7 :

2008

ISO 11138-1 : 2006 Sterilization of health care products — Biological indicators — Part 1: General requirements

IS/ISO 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General requirements [MHD 12 (0333) under processes]

Identical

ISO 11138-2 : 2009 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

IS/ISO 11138-2:2009, Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes [MHD 12 (0334) under processes]

Identical

ISO 11140-1 Sterilization of health care products — Chemical indicators — Part 1: General requirements

IS/ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements [MHD 12 (0490) under processes]

Identical with 11140-1:2014

ISO 11737-1 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products

IS/ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products [MHD 12 (0497) under processes]

Identical with

ISO 11737-1 :

2006

https://www.iso.org/obp/ui/%23iso:std:iso:10012:en


https://www.iso.org/obp/ui/%23iso:std:iso:10993:-7:en


https://www.iso.org/obp/ui/%23iso:std:iso:11138:-1:ed-2:en




Doc: MHD 12 (0489) IS/ISO 11135 : 2014

International Standard Corresponding Indian Standard Degree of

Equivalence

ISO 11737-2 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

IS/ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process [MHD 12 (0498) under processes]

Identical with ISO 11737-2 : 2009

ISO 13485:2003/Cor 1:2009 Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1

IS/ISO 13485:2003/Cor 1:2009 Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1

Identical

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 110002 Email: [email protected], [email protected] ; [email protected];



https://www.iso.org/obp/ui/%23iso:std:iso:13485:ed-1:en





Doc: MHD 12 (0489) IS/ISO 11135 : 2014

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 12(0489)/ISO 11135 : 2014 TITLE: Sterilization of health care products — Ethylene oxide — Requirements for

the development, validation and routine control of a sterilization process for

medical devices'

LAST DATE OF COMMENTS: 16-01-2016

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

Doc: MHD 12(0490) IS/ISO 11140-1:2014



मसौदा भारतीय मानक

वाय दखभाल उपाद� का �वसरमण — रासाय�नक सकतक भाग 1 सामाय अप�ाए

Draft Indian Standard STERILIZATION OF HEALTH CARE PRODUCTS — CHEMICAL INDICATORS

PART 1: GENERAL REQUIREMENTS

ICS 11.080.01

© BIS 2015



NEW DELHI 110002


Doc: MHD 12(0490) IS/ISO 11140-1:2014




NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with ISO 11140-1 : 2014 ‘Sterilization of

health care products — Chemical indicators — Part 1: General requirements' issued by

the International Organization for Standardization (ISO) was adopted by the Bureau of

Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and

Hospital Planning Division Council.

This part standard specifies performance requirements and/or test methods for chemical indicators intended for use with sterilization processes employing steam, dry heat, ethylene oxide, γ or β radiation, low temperature steam and formaldehyde or vaporized hydrogen peroxide.

This standard consist the following parts under the general title ‘Sterilization of health care products — Chemical indicators’:

Part 1 General requirements

Part 3 Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

Part 4 Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

Part 5 Class 2 indicators for Bowie and Dick-type air removal tests

The text of ISO 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:





Doc: MHD 12(0490) IS/ISO 11140-1:2014




editions indicated:


Equivalence

ISO 11135 : 2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

IS/ISO 11135 : 2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices [Doc. MHD 12 (0489) under process]

Identical

ISO 11137-1 : 2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-1 : 2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Doc. MHD 12 (0494) under process]

do

ISO 11137-2 : 2013 Sterilization

of health care products —

Radiation — Part 2:

Establishing the sterilization

dose

ISO 11137-2 : 2013 Sterilization of

health care products — Radiation —

Part 2: Establishing the sterilization

dose [Doc. MHD 12 (0495) under

process]

do

ISO 11137-3 : 2006 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

ISO 11137-3 : 2006 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects [Doc. MHD 12 (0496) under process]

ISO 11138-1 : 2006 Sterilization of health care products — Biological indicators — Part 1: General requirements

ISO 11138-1 : 2006 Sterilization of health care products — Biological indicators — Part 1: General requirements [Doc. MHD 12 (0333) under process]

ISO 11138-2 : 2006 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

ISO 11138-2 : 2006 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes [Doc. MHD 12 (0334) under process]













Doc: MHD 12(0490) IS/ISO 11140-1:2014


ISO 11138-3 : 2006 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes

ISO 11138-3 : 2006 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes [Doc. MHD 12 (0335) under process]

Identical

ISO 11138-4 : 2006 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes

ISO 11138-4 : 2006 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes [Doc. MHD 12 (0336) under process]

do

ISO 11138-5 : 2006 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

ISO 11138-5 : 2006 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes [Doc. MHD 12 (0337) under process]

do

ISO 11140-3 : 2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

ISO 11140-3 : 2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test [Doc. MHD 12 (0491) under process]

do

ISO 11140-4 : 2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO 11140-4 : 2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration [Doc. MHD 12 (0492) under process]

do

ISO 11140-5 : 2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

ISO 11140-5 : 2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests [Doc. MHD 12 (0493) under process]

do













Doc: MHD 12(0490) IS/ISO 11140-1:2014

The technical committee has reviewed the provisions of the following International

Standard referred in this adopted standard and has decided that it is acceptable for use

in conjunction with this standard:

International Standard Title

ISO 8601 : 2004 Data elements and interchange formats — Information

interchange — Representation of dates and times

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 110002 Email: [email protected], [email protected] ; [email protected];





Doc: MHD 12(0490) IS/ISO 11140-1:2014



Doc No.: MHD 12(0490)/ISO 11140-1:2014

TITLE: Sterilization of health care products — Chemical indicators — Part 1:

General requirements LAST DATE OF COMMENTS: 16-01-2016


_____________________________________________________________________

Sl.

No.


Commentator/

Organization/

Abbreviation

Type of

Comments

(General/Editorial/

Technical)


change

Doc: MHD 12 (0491) IS/ISO 11140-3 : 2007




वाय दखभाल उपाद� का �वसरमण — रासाय�नक सकतक भाग 3 बॉवी और �डक रकार भाप प�नरशन पर��ण म� उपयोग क �लए

18रणी18 2 सचक रणाल�


PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST

ICS 11.080.01

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0491) IS/ISO 11140-3 : 2007




NATIONAL FOREWORD

This Indian Standard (Part 3) which is identical with ISO 11140-3 : 2007 ‘Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The Bowie and Dick test is a performance test for steam sterilizers for wrapped goods and porous loads. As such it is performed during the demonstration of conformance of steam sterilizers to EN 285 and as a routine test of performance in ISO 17665-1. The test method is described in EN 285. This standard consist the following parts under the general title ‘Sterilization of health care products — Chemical indicators’:






Standard without deviations. Certain conventions are, however, not identical to those

used in Indian Standards. Attention is particularly drawn to the following:





Doc: MHD 12 (0491) IS/ISO 11140-3 : 2007




editions indicated:


ISO 5636-3 Paper and Board – Determination of Air Permeance (Medium range), Part 3 Bendtsen Method

IS/ISO 5636 : 1992 Paper and Board – Determination of Air Permeance (Medium range), Part 3 Bendtsen Method

Identical with

ISO 5636 :

1992

ISO 11140-1: 20051) Sterilization of health care products — Chemical indicators — Part 1: General requirements

IS/ISO 11140-1 : 2014 Sterilization of health care products — Chemical indicators — Part 1: General requirements [Doc. MHD 12 (0490) under process]

Identical with

ISO 11140-1 : 2014

The technical committee has reviewed the provisions of the following International Standard referred in this adopted standard and has decided that it is acceptable for use in conjunction with this standard:


ISO 5-1 Photography — Density measurements — Part 1: Terms, symbols and notations

ISO 5-3 Photography — Density measurements — Part 3: Spectral conditions

ISO 5-4:1995 Photography — Density measurements — Part 4: Geometric conditions for reflection density

ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples

ISO 2248 Packaging — Complete, filled transport packages — Vertical impact test by dropping

ISO 5457 Technical product documentation — Sizes and layout of drawing

sheets

ISO/CIE 10526:199 CIE standard illuminants for colorimetry EN 285:2006 Sterilization — Steam sterilizers — Large sterilizers

1) Since revised in 2014.





Doc: MHD 12 (0491) IS/ISO 11140-3 : 2007






Doc: MHD 12 (0491) IS/ISO 11140-3 : 2007



Doc No.: MHD 12(0491)/ISO 11140-3:2007 TITLE: Sterilization of health care products — Chemical indicators — Part 3: Class

2 indicator systems for use in the Bowie and Dick-type steam penetration

test' LAST DATE OF COMMENTS: 16-01-2016


_____________________________________________________________________

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Doc: MHD 12 (0492) IS/ISO 11140-4 : 2007




वाय दखभाल उपाद� का �वसरमण — रासाय�नक सकतक

भाग 4 बॉवी और �डक रकार क भाप प�नरशन पर��ण म� उपयोग क �लए एक

�वकप क प म� 18रणी18 2 सकतक


PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION

ICS 11.080.01

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0492) IS/ISO 11140-4 : 2007




NATIONAL FOREWORD

This Indian Standard (Part 4) which is identical with ISO 11140-4 : 2007 ‘Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The Bowie and Dick test is a performance test for steam sterilizers for wrapped goods and porous loads. As such it is performed during the demonstration of conformance of steam sterilizers to EN 285 and as a routine test of performance in ISO 17665-1. The test method is described in EN 285. This standard consist the following parts under the general title ‘Sterilization of health care products — Chemical indicators’:











Doc: MHD 12 (0492) IS/ISO 11140-4 : 2007




editions indicated:


Equivalence



Identical with

ISO 5636 :

1992

I S 10012-11) Quality

Assurance for Measuring

Equipment - Part 1

Metrological Confirmat ion

System for Measuring

Equipment

I S/ I SO 10012 : 2003 Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment

Identical with

ISO 10012 :

2003



Identical with

ISO 11140-1 : 2014

The technical committee has reviewed the provisions of the following International

Standard referred in this adopted standard and has decided that it is acceptable for use in conjunction with this standard:


ISO 5-1 Photography — Density measurements — Part 1: Terms, symbols and notations

ISO 5-3 Photography — Density measurements — Part 3: Spectral conditions

ISO 5-4:1995 Photography — Density measurements — Part 4: Geometric conditions for reflection density

ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples

ISO 2248 Packaging — Complete, filled transport packages — Vertical impact test by dropping

1) Since revised as ISO 10012 : 2003 ‘Requirem ents for Measurem ent Processes and Measuring

Equipm ent ’.






Doc: MHD 12 (0492) IS/ISO 11140-4 : 2007


ISO 5457 Technical product documentation — Sizes and layout of drawing sheets

ISO/CIE 10526:199 CIE standard illuminants for colorimetry IEC 60584-2:1982 Thermocouples. Part 2: Tolerances IEC 60584-2/am1:1989 Amendment 1 — Thermocouples. Part 2: Tolerances IEC 60751:1983 Industrial platinum resistance thermometer sensors IEC 60751/am1:1986 Amendment 1 — Industrial platinum resistance thermometer

sensors EN 285:2006 Sterilization — Steam sterilizers — Large sterilizers






Doc: MHD 12 (0492) IS/ISO 11140-4 : 2007




2 indicators as an alternative to the Bowie and Dick-type test for detection

of steam penetration' LAST DATE OF COMMENTS: 16-01-2016


_____________________________________________________________________

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Doc: MHD 12 (0493) IS/ISO 11140-5 : 2007




वाय दखभाल उपाद� का �वसरमण — रासाय�नक सकतक

भाग 5 बॉवी और �डक रकार क हवा अपनयन पर��ण क �लए 18रणी18 2

सकतक


PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS

ICS 11.080.01

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0493) IS/ISO 11140-5 : 2007




NATIONAL FOREWORD

This Indian Standard (Part 5) which is identical with ISO 11140-5 : 2007 ‘Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The air removal test is used to evaluate the efficacy of air removal during the pre-vacuum phase of a prevacuum sterilization cycle or during the pulsing stage of positive pulsing cycles if non-condensable gases were present in the steam. Retention of air due to an inefficient air removal stage or the presence of an air leak or non-condensable gases during the air removal stage are circumstances which can lead to failure of the test. This part of standard describes the requirements for Class 2 indicators for Bowie and Dick-type air removal test sheets and packs. This standard consist the following parts under the general title ‘Sterilization of health care products — Chemical indicators’:











Doc: MHD 12 (0493) IS/ISO 11140-5 : 2007




editions indicated:




Identical with

ISO 5636 :

1992



Identical with ISO 11140-1 : 2014

The technical committee has reviewed the provisions of the following International Standard referred in this adopted standard and has decided that it is acceptable for use in conjunction with this standard:


ISO 5-4 : 1995 Photography — Density measurements — Part 4: Geometric conditions for reflection density

IEC 60584-2 : 1982 Thermocouples. Part 2: Tolerances IEC 60751 : 1983 Industrial platinum resistance thermometer sensors






Doc: MHD 12 (0493) IS/ISO 11140-5 : 2007






Doc: MHD 12 (0493) IS/ISO 11140-5 : 2007




2 indicators for Bowie and Dick-type air removal tests' LAST DATE OF COMMENTS: 16-01-2016


_____________________________________________________________________

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Doc: MHD 12 (0494) IS/ISO 11137-1 : 2006



मसौदा भारतीय मानक वाय दखभाल उपाद� का �वसरमण — �व�करण

भाग 1 �च�कसा उपकरण� क �लए एक �वसरमण र�रया क �वकास, सयापन और �दनचया पर �नयरण क �लए आवयकताए

Draft Indian Standard STERILIZATION OF HEALTH CARE PRODUCTS — RADIATION

PART 1 REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

-

ICS 11.080.01

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0494) IS/ISO 11137-1 : 2006




NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11137-1 : 2006 ‘Sterilization of health-care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard consists of the following parts, under the general title Sterilization of health care products — Radiation:

— Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

— Part 2: Establishing the sterilization dose — Part 3: Guidance on dosimetric aspects

This part of standard describes the requirements for ensuring that the activities associated with the process of radiation sterilization are performed properly. These activities are described in documented work programmes designed to demonstrate that the radiation process will consistently yield sterile products on treatment with doses falling within the predetermined limits.




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.




editions indicated:

Doc: MHD 12 (0494) IS/ISO 11137-1 : 2006

International Standard Corresponding Indian

Standard Degree of

Equivalence

ISO 10012-11) Measurement management systems — Requirements for measurement processes and measuring equipment Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system for measuring equipment


Identical with

ISO 10012 :

2003

ISO 11137-2 : 20062) Sterilization of health care products — Radiation — Part 1: General requirements

IS/ISO 11137-2 : 2013 Sterilization of health care products — Biological indicators — Part 1: General requirements [MHD 12 (0495) under processes]

Identical with

ISO 11737-2 : 2013


IS/ISO 11737-1 : 2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products [MHD 12 (0497) under processes]

Identical with

ISO 11737-1 : 2006


IS/ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process [MHD 12 (0498) under processes]

Identical with

ISO 11737-2 : 2009

ISO 13485 : 2003 Medical devices — Quality management systems — Requirements for regulatory purposes

IS/ISO 13485 : 2003 Medical devices — Quality management systems — Requirements for regulatory purposes

Identical

1) Since revised as ISO 10012 : 2003 ‘Measurement management systems — Requirements for

measurement processes and measuring equipment













Doc: MHD 12 (0494) IS/ISO 11137-1 : 2006






Doc: MHD 12 (0494) IS/ISO 11137-1 : 2006



Doc No.: MHD 12(0494)/ISO 11137-1 : 2006 TITLE: Sterilization of health care products — Radiation — Part 1: Requirements

for development, validation and routine control of a sterilization process for

medical devices'



_____________________________________________________________________

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Doc: MHD 12 (0495) IS/ISO 11137-2 : 2013



मसौदा भारतीय मानक वाय दखभाल उपाद� का �वसरमण — �व�करण भाग 2 �वसरमण क� 0 मारा20 (डोज) था�पत करना


PART 2 ESTABLISHING THE STERILIZATION DOSE

ICS 11.080.01

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0495) IS/ISO 11137-2 : 2013




NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11137-2 : 2013 ‘Sterilization of health-care products — Radiation — Part 2: Establishing the sterilization dose’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.




This part of standard describes methods that can be used to establish the sterilization dose in accordance with one of the two approaches specified in 8.2 of IS/ISO 11137-1 : 2006. The methods used in these approaches are:

— dose setting to obtain a product-specific dose; — dose substantiation to verify a preselected dose of 25 kGy or 15 kGy.

This part of standard also describes methods that can be used to carry out sterilization dose audits in accordance with IS/SO 11137-1 : 2006, Clause 12. Following establishment of the sterilization dose, sterilization dose audits are performed routinely to confirm that the sterilization dose continues to achieve the desired SAL.





https://www.iso.org/obp/ui/%23iso:std:iso:11137:-1:ed-1:en:clause:8.2

https://www.iso.org/obp/ui/%23iso:std:iso:11137:-1:ed-1:en:clause:8.2


Doc: MHD 12 (0495) IS/ISO 11137-2 : 2013




editions indicated:


Equivalence

ISO 11137- 1 : 2006 Sterilization of health care products — Radiation — Part 1: General requirements


Identical


IS/ISO 11737-1 : 2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products [MHD 12 (0497) under processes]

Identical with

ISO 11737-1 : 2006


IS/ISO 11737-2 : 2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process [MHD 12 (0498) under processes]

Identical with

ISO 11737-2 : 2009













Doc: MHD 12 (0495) IS/ISO 11137-2 : 2013



Doc No.: MHD 12(0495)/ISO 11137-2 : 2013 TITLE: Sterilization of health care products — Radiation — Part 2: Establishing the

sterilization dose’



_____________________________________________________________________

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Doc: MHD 12 (0496) IS/ISO 11137-3 : 2006



मसौदा भारतीय मानक वाय दखभाल उपाद� का �वसरमण — �व�करण

भाग 3 डो�सम�रक पहलओ पर �दशा�नद�श


PART 3 GUIDANCE ON DOSIMETRIC ASPECTS

ICS 11.080.01

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0496) IS/ISO 11137-3 : 2006




NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11137-3 : 2006 ‘Sterilization of health-care products — Radiation — Part 3: Guidance on dosimetric aspects’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.




This standard describes requirements that, if met, will provide a radiation sterilization process, intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the requirements helps ensure that this activity is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on product after sterilization.






Doc: MHD 12 (0496) IS/ISO 11137-3 : 2006




editions indicated:


Equivalence

ISO 11137- 1 Sterilization of health care products — Radiation — Part 1: General requirements


Identical

ISO 11137- 2 : 20061) Sterilization of health care products — Radiation — Part 1: General requirements


Identical with

ISO 11137-2 : 2013












Doc: MHD 12 (0496) IS/ISO 11137-3 : 2006



Doc No.: MHD 12(0496)/ISO 11137-3 : 2006 TITLE: Sterilization of health care products — Radiation — Part 3: Guidance on

dosimetric aspects’



_____________________________________________________________________

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Doc: MHD 12 (0497) IS/ISO 11737-1 : 2006



मसौदा भारतीय मानक �च�कसा उपकरण� का �वसरमण — स�मजीव�व�ानी �व�धया भाग 1: उपाद� पर स�मजीव� क� जनसया �नधारण करना

Draft Indian Standard STERILIZATION OF MEDICAL DEVICES -- MICROBIOLOGICAL METHODS PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON

PRODUCTS

ICS 11.080.01; 07.100.10

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0497) IS/ISO 11737-1 : 2006




NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11737-1 : 2006 ‘Sterilization of medical

devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products’ issued by the International Organization for Standardization

(ISO) was adopted by the Bureau of Indian Standards on the recommendation of the

Hospital Equipment and Surgical Disposable Products, Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.


— Part 1: Determination of a population of microorganisms on products — Part 2: Tests of sterility performed in the validation of a sterilization process

This part of standard specifies the requirements to be met in the determination of bioburden. The requirements are the normative parts of this part of standard with which compliance is claimed. The guidance given in the informative annexes is not normative and is not provided as a checklist for auditors. The guidance provides explanations and methods that are regarded as being a suitable means for complying with the requirements. Methods other than those given in the guidance may be used, if they are effective in achieving compliance with the requirements of this part of standard.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those




Doc: MHD 12 (0497) IS/ISO 11737-1 : 2006




editions indicated:


ISO 10012 Measurement management systems — Requirements for measurement processes and measuring equipment


Identical with

ISO 10012 :

2003



Identical

ISO/IEC 17025 : 2005 General requirements for the competence of testing and calibration laboratories

IS/ISO/IEC 17025 : 2005 General requirements for the competence of testing and calibration laboratories

do







https://www.iso.org/obp/ui/%23iso:std:iso-iec:17025:ed-2:en





Doc: MHD 12 (0497) IS/ISO 11737-1 : 2006



Doc No.: MHD 12(0497)/ISO 11737-1 : 2006 TITLE: ‘Sterilization of medical devices -- Microbiological methods -- Part 1:

Determination of a population of microorganisms on products



_____________________________________________________________________

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Doc: MHD 12 (0498) IS/ISO 11737-2 : 2009



मसौदा भारतीय मानक �च�कसा उपकरण� का �वसरमण — स�मजीव�व�ानी �व�धया

भाग 2: �वसरमण र�रया क� प�रभाषा, सयापन और रखरखाव म� जीवाणर�हणता टट का �नपादन

Draft Indian Standard STERILIZATION OF MEDICAL DEVICES -- MICROBIOLOGICAL METHODS

PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION

AND MAINTENANCE OF A STERILIZATION PROCESS

ICS 11.080.01; 07.100.10

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0498) IS/ISO 11737-2 : 2009




NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11737-2 : 2009 ‘Sterilization of medical

devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition,

validation and maintenance of a sterilization process’ issued by the International

Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards

on the recommendation of the Hospital Equipment and Surgical Disposable Products,

Sectional Committee and approval of the Medical Equipment and Hospital Planning

Division Council.


— Part 1: Determination of a population of microorganisms on products — Part 2: Tests of sterility performed in the definition, validation and maintenance

of a sterilization process

A sterile medical device is one that is free of viable microorganisms. International standards that specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see, for example, IS/ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones.







Doc: MHD 12 (0498) IS/ISO 11737-2 : 2009




editions indicated:


ISO 10012 Measurement management systems — Requirements for measurement processes and measuring equipment


Identical with

ISO 10012 :

2003

ISO 11737-1 : 2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products

IS/ISO 11737-1 : 2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products [MHD 12 (0497) under process]

Identical



do

ISO/IEC 17025 : 2005 General requirements for the competence of testing and calibration laboratories

IS/ISO/IEC 17025 : 2005 General requirements for the competence of testing and calibration laboratories

do





https://www.iso.org/obp/ui%23iso:std:iso:11737:-1:ed-2:en

https://www.iso.org/obp/ui%23iso:std:iso:11737:-1:ed-2:en








Doc: MHD 12 (0498) IS/ISO 11737-2 : 2009



Doc No.: MHD 12(0498)/ISO 11737-2 : 2009 TITLE: Sterilization of medical devices -- Microbiological methods -- Part 2: Tests

of sterility performed in the definition, validation and maintenance of a

sterilization process LAST DATE OF COMMENTS: 16-01-2016


_____________________________________________________________________

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Doc: MHD 12 (0499) IS/ISO 11607-1 : 2006



मसौदा भारतीय मानक ट�मनल� �वसर�मत �च�कसा उपकरण� क �लए पकिजग

भाग 1: सामरी, �वसरमण बाधा रणाल� और पकिजग �सटम क �लए आवयकताए

Draft Indian Standard PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND

PACKAGING SYSTEMS

ICS 11.080.30

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0499) IS/ISO 11607-1 : 2006




NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11607-1 : 2006 ‘Packaging for terminally

sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and

packaging systems’ issued by the International Organization for Standardization (ISO)

was adopted by the Bureau of Indian Standards on the recommendation of the Hospital

Equipment and Surgical Disposable Products, Sectional Committee and approval of the

Medical Equipment and Hospital Planning Division Council.

This standard consists of the following parts, under the general title Packaging for terminally sterilized medical devices:

— Part 1: Requirements for materials, sterile barrier systems and packaging systems

— Part 2: Validation requirements for forming, sealing and assembly processes

This part of ISO 11607 specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs, and sterilization methods. IS/ISO 11607-2 describes the validation requirements for forming, sealing and assembly processes. This part of standard is harmonized with EN 868-1 and specifies general requirements for all packaging materials whereas EN 868 Parts 2 to 10 specify particular requirements for a range of commonly used materials. Both parts of this standard were designed to meet the Essential Requirements of the European Medical Device Directives.







Doc: MHD 12 (0499) IS/ISO 11607-1 : 2006




editions indicated:


ISO 5636-5 : 2003 Paper and board — Determination of air permeance and air resistance (medium range) — Part 5: Gurley method

ISO 5636-5 : 2003 Paper and board — Determination of air permeance and air resistance (medium range) — Part 5: Gurley method

Identical with

ISO 10012 :

2003








Doc: MHD 12 (0499) IS/ISO 11607-1 : 2006



Doc No.: MHD 12(0499)/ISO 11607-1 : 2006 TITLE: Packaging for terminally sterilized medical devices

Part 1: Requirements for materials, sterile barrier systems and packaging

systems



_____________________________________________________________________

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Doc: MHD 12 (0500) IS/ISO 11607-2 : 2006



मसौदा भारतीय मानक ट�मनल� �वसर�मत �च�कसा उपकरण� क �लए पकिजग

भाग 2: गठन (फो�म�ग), सी�लग तथा अस�बल� र�रयाओ क �लए सयापन अप�ाए

Draft Indian Standard PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY

PROCESSES

ICS 11.080.30

© BIS 2015



NEW DELHI 110002


Doc: MHD 12 (0500) IS/ISO 11607-2 : 2006




NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11607-2 : 2006 ‘Packaging for terminally

sterilized medical devices Part 2: Validation requirements for forming, sealing and

assembly processes’ issued by the International Organization for Standardization (ISO)

was adopted by the Bureau of Indian Standards on the recommendation of the Hospital

Equipment and Surgical Disposable Products, Sectional Committee and approval of the

Medical Equipment and Hospital Planning Division Council.

Technical amendment 1 published in 2014 to the above International Standard has been given at the end of this publication.

This standard consists of the following parts, under the general title Packaging for terminally sterilized medical devices:

— Part 1: Requirements for materials, sterile barrier systems and packaging systems

— Part 2: Validation requirements for forming, sealing and assembly processes

Medical devices delivered in a sterile state should be designed, manufactured and packed to ensure that they are sterile when placed on the market and remain sterile, under documented storage and transport conditions, until the sterile barrier system is damaged or opened. Additionally, medical devices delivered in a sterile state should have been manufactured and sterilized by an appropriate, validated method.






Doc: MHD 12 (0500) IS/ISO 11607-2 : 2006




editions indicated:


ISO 11601-1 : 2006 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

IS/ISO 11601-1 : 2006 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

[Doc MHD 12 (0499) is under process]

Identical with

ISO 11601-1

: 2006






Doc: MHD 12 (0500) IS/ISO 11607-2 : 2006



Doc No.: MHD 12(0500)/ISO 11607-2 : 2006 TITLE: Packaging for terminally sterilized medical devices Part 2: Validation

requirements for forming, sealing and assembly processes



_____________________________________________________________________

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