I.S. EN ISO 11737-2:2020
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 (ISO 11737-2:2019)
Hardcopy , PDF
English
01-06-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Selection of product
6 Methods for performing tests of sterility
7 Assessment of the method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process
Annex B (informative) Typical assignment of responsibilities
Bibliography
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.
| Committee |
TC 198
|
| DocumentType |
Standard
|
| Pages |
44
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11737-2:2020 | Identical |
| ISO 11737-2:2019 | Identical |
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