Standard Svensk standard · SS-EN ISO 11737-2:2009

Sterilisering av medicintekniska produkter - Mikrobiologiska metoder - Del 2: Steriliseringstest för att definiera, validera och upprätthålla en steriliseringsprocess (ISO 11737-2:2009)

Status: Gällande

Omfattning
1.1 This part of ISO 11737 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 part of ISO 11737 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 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO 17665-1.
c) culturing of biological indicators or inoculated products.

NOTE 2 Guidance on culturing biological indicators is included in ISO 14161[8].

Ämnesområden

Medicinsk mikrobiologi (07.100.10) Sterilisering och desinficering allmänt (11.080.01)


Produktinformation

Språk: Engelska

Framtagen av: Rengöring, desinfektion och sterilisering, SIS/TK 349

Internationell titel: 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)

Artikelnummer: STD-71896

Utgåva: 2

Fastställd: 2009-11-30

Antal sidor: 32

Ersätter: SS-EN ISO 11737-2