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
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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.
| 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 |
| SN EN ISO 11138-3 : 2017 | Identical |
| UNI EN ISO 11138-3 : 2009 | Identical |
| NS EN ISO 11138-3 : 2017 | Identical |
| BS EN ISO 11138-3:2017 | Identical |
| UNE-EN ISO 11138-3:2017 | Identical |
| EN ISO 11138-3:2017 | Identical |
| ISO 11138-3:2017 | Identical |
| NF EN ISO 11138-3 : 2017 | Identical |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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