SS-EN-ISO-11737-2 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)

SS-EN-ISO-11737-2 - 2020 EDITION - CURRENT
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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 which has been 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), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

To find similar documents by classification:

07.100.10 (Medical microbiology Laboratory medicine, see 11.100)

11.080 (Sterilization and disinfection)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)


Active implantable medical devices. Medical devices. In vitro diagnostic medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

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Designation Name

SS-EN ISO 11737-2:2020

Revision Level

2020 EDITION

Status

Current

Publication Date

May 18, 2020

Language(s)

English

Page Count

40

International Equivalent

EN ISO 11737-2:2020(IDT); ISO 11737-2:2019(IDT)