SSH EN ISO 11737-2:2009

Sterilizimi i pajisjeve mjekësore - Metodat mikrobiologjike - Pjesa 2: Testet e sterilitetit të kryera në përkufizimin, vlefshmërinë dhe mirëmbajtjen e procesit të sterilizimit (ISO 11737-2:2009)

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)

Scope

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.

Related directives

Directives related to this standards.