• There are no items in your cart

ISO 11737-2:2019

Current
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
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

12-02-2019

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.

DocumentType
Standard
Pages
16
PublisherName
International Organization for Standardization
Status
Current
Supersedes

View more information
US$111.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.