BS EN ISO 11138-5:2017
Current
The latest, up-to-date edition.
Sterilization of health care products. Biological indicators Biological indicators for low-temperature steam and formaldehyde sterilization processes
Hardcopy , PDF
English
04-30-2017
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 866-5 and 04/30078111 DC (08/2006) Supersedes 15/30321514 DC. (04/2017)
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| DocumentType |
Standard
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| Pages |
18
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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 low-temperature steam and formaldehyde as the sterilizing agent.
NOTE1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO14937 .
NOTE2 Requirements for work place safety can be provided by national or regional regulations.
| Standards | Relationship |
| EN ISO 11138-5:2017 | Identical |
| I.S. EN ISO 11138-5:2017 | Identical |
| NEN EN ISO 11138-5 : 2017 | Identical |
| UNI EN ISO 11138-5 : 2006 | Identical |
| NS EN ISO 11138-5 : 2017 | Identical |
| SN EN ISO 11138-5 : 2017 | Identical |
| DIN EN ISO 11138-5:2015-10 (Draft) | Identical |
| NBN EN ISO 11138-5 : 2006 | Identical |
| ISO 11138-5:2017 | Identical |
| UNE-EN ISO 11138-5:2017 | Identical |
| NF EN ISO 11138-5 : 2017 | Identical |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| 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 |
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