07/30157769 DC : DRAFT DEC 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS
31-03-2010
23-11-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement
5 Selection of product
5.1 General
5.2 Sample item portion (SIP)
5.3 Packaging of product and Sample Item Portions
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 of a sterilization process
A.1 Scope
A.2 Normative references
A.3 Definitions
A.4 Quality management system elements
A.4.1 Documentation
A.4.2 Management responsibility
A.4.3 Product realization
A.4.4 Measurement, analysis and improvement
A.5 Selection of product
A.5.1 General
A.5.2 Sample Item Portion (SIP)
A.5.3 Packaging of product and Sample Item Portions
A.6 Methods for performing tests of sterility
A.7 Assessment of method for performing tests of sterility
A.8 Maintenance of the method for performing tests of
sterility
Bibliography
BS EN ISO 11737-2
| Committee |
CH/198
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 10012-1:1992 | Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment |
| 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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