Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
Abstract
ISO 11737-2:2009 specifies 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. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
DIN EN ISO 11737-2:2010-04 (E)
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
(ISO 11737-2:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Quality management system elements …………………………………………………………………………….7
5 Selection of product ………………………………………………………………………………………………………..8
6 Methods for performing tests of sterility ………………………………………………………………………….9
7 Assessment of method for performing tests of sterility ………………………………………………….10
8 Maintenance of the method for performing tests of sterility ……………………………………………10
Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a
sterilization process ………………………………………………………………………………………………………11
Bibliography …………………………………………………………………………………………………………………………………19
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices ………….21
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices …………………………………………22
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices ………………23