UNE-EN ISO 11138-5:2017
Current
The latest, up-to-date edition.
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
Hardcopy , PDF
Spanish, Castilian, English
11-10-2017
This part of ISO 11138 provides specific 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.NOTE 1Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.NOTE 2Requirements for work place safety may be provided by national or regional regulations.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 866-5. (05/2007)
|
| DocumentType |
Standard
|
| Pages |
15
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 11138-5:2017 | Identical |
| I.S. EN ISO 11138-5:2017 | Identical |
| NEN EN ISO 11138-5 : 2017 | Identical |
| NS 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 |
| BS 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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