Sterilizace zařízení

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 204 (Sterilization of medical devices)
Původce: CEN
K připomínkám do: 29.07.2018
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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), and

NOTE 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].