I.S. EN ISO 11138-3:2017
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017)
Hardcopy , PDF
English
01-01-2017
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.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination of
resistance to moist heat sterilization
Annex B (normative) - Calculation of z value and
coefficient of determination, r[2]
Bibliography
Defines requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes I.S. EN 866-3 and I.S. EN 866-7. (09/2006)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11138-3:2015-10 (Draft) | Identical |
| NBN EN ISO 11138-3 : 2009 | Identical |
| NS EN ISO 11138-3 : 2017 | Identical |
| BS EN ISO 11138-3:2017 | Identical |
| EN ISO 11138-3:2017 | Identical |
| ISO 11138-3:2017 | Identical |
| NF EN ISO 11138-3 : 2017 | Identical |
| UNE-EN ISO 11138-3:2017 | Identical |
| DIN EN ISO 11138-3:2017-07 | Equivalent |
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