BS EN ISO 11737-2:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterilization of medical devices. Microbiological methods Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Hardcopy , PDF
19-05-2020
English
31-03-2010
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Selection of product
6 Methods for performing tests of sterility
7 Assessment of method for performing tests of sterility
8 Maintenance of the method for performing tests of
sterility
Annex A (informative) - Guidance on tests of sterility
performed in validation and maintenance of a
sterilization process
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable Medical
Devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZC (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 98/79/EC on in vitro diagnostic medical
devices
Describes the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 95/563133 DC (08/2004) Supersedes 07/30157769 DC. (03/2010)
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11737-2 : 2010 | Identical |
| SN EN ISO 11737-2 : 2010 | Identical |
| UNE-EN ISO 11737-2:2010 | Identical |
| EN ISO 11737-2:2009 | Identical |
| DIN EN ISO 11737-2:2010-04 | Identical |
| NBN EN ISO 11737-2 : 2010 | Identical |
| NS EN ISO 11737-2 : 2009 | Identical |
| UNI EN ISO 11737-2 : 2010 | Identical |
| ISO 11737-2:2009 | Identical |
| NEN EN ISO 11737-2 : 2009 | Identical |
| I.S. EN ISO 11737-2:2009 | Identical |
| ONORM EN ISO 11737-2 : 2010 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| 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 14160:2011 | Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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