ISO 11737-2:2019
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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
02-12-2019
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11737-2:2020-07 | Identical |
| ANSI/AAMI/ISO 11737-2:2019 | Identical |
| SS-EN ISO 11737-2:2020 | Identical |
| EN ISO 11737-2:2020 | Identical |
| BS EN ISO 11737-2:2020 | Identical |
| NEN-EN-ISO 11737-2:2020 | Identical |
| I.S. EN ISO 11737-2:2020 | Identical |
| ÖNORM EN ISO 11737-2:2020 06 15 | Identical |
| NS-EN ISO 11737-2:2020 | Identical |
| UNI EN ISO 11737-2:2021 | Identical |
| SN EN ISO 11737-2:2020 | Identical |
| CSA ISO 11737-2:21 | Identical |
| PN-EN ISO 11737-2:2020-11 | Identical |
| NF EN ISO 11737-2:2020 | Identical |
| UNE-EN ISO 11737-2:2020 | Identical |
| ABNT NBR ISO 11737-2:2024 | Identical |
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.