UNE-EN ISO 11737-2:2020
Current
The latest, up-to-date edition.
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Hardcopy , PDF
English, Spanish, Castilian
16-12-2020
1.1 This document 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.1.2 This document is not applicable to:a) sterility testing for routine release of product that has been subjected to a sterilization process,b) performing a test for sterility (see 3.12), andNOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.c) culturing of biological indicators or inoculated products.NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7[5].
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 11737-2:2020 | Identical |
| ISO 11737-2:2019 | Identical |
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