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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded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