I.S. EN ISO 11737-1:2018/A1:2021
Current
The latest, up-to-date edition.
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737- 1:2018/Amd 1:2021)
Hardcopy , PDF
English
04-07-2021
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of products
6 Methods of determination and microbial characterization of bioburden
7 Validation of the method for determining bioburden
8 Routine determination of bioburden and interpretation of data
9 Maintenance of the method for determining bioburden
Annex A (informative) Guidance on the determination of a population of microorganisms
on products
Annex B (informative) Guidance on methods to determine bioburden
Annex C (informative) Validation of bioburden recovery efficiency
Annex D (informative) Typical assignment of responsibilities
Bibliography
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
94
|
| 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 |
| ISO 11737-1:2018/Amd 1:2021 | Identical |
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