BS EN ISO 11138-3:2017
Current
The latest, up-to-date edition.
Sterilization of health care products. Biological indicators Biological indicators for moist heat sterilization processes
Hardcopy , PDF
English
30-04-2017
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/198
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| DevelopmentNote |
Supersedes BS EN 866-3, BS EN 866-7 and 04/30078103 DC (08/2006) Supersedes 15/30321508 DC. (04/2017)
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| DocumentType |
Standard
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| Pages |
20
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
This document specifies 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.
NOTE1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO17665 series.
NOTE2 National or regional regulations can provide requirements for work place safety.
| Standards | Relationship |
| ISO 11138-3:2017 | Identical |
| NF EN ISO 11138-3 : 2017 | Identical |
| 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 |
| UNE-EN ISO 11138-3:2017 | Identical |
| EN ISO 11138-3:2017 | Identical |
| I.S. 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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