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07/30157769 DC : DRAFT DEC 2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS
Superseded date

03-31-2010

Published date

11-23-2012

Publisher

British Standards Institution

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Superseded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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