UNE-EN ISO 11138-4:2017
Current
The latest, up-to-date edition.
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.NOTE 1Requirements for validation and control of dry heat 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 866-6. (05/2007)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| BS EN ISO 11138-4:2017 | Identical |
| NBN EN ISO 11138-4 : 2006 | Identical |
| NS EN ISO 11138-4 : 2017 | Identical |
| NEN EN ISO 11138-4 : 2017 | Identical |
| I.S. EN ISO 11138-4:2017 | Identical |
| DIN EN ISO 11138-4:2015-10 (Draft) | Identical |
| EN ISO 11138-4:2017 | Identical |
| ISO 11138-4:2017 | Identical |
| NF EN ISO 11138-4 : 2017 | Identical |
| ISO 18472:2006 | Sterilization of health care products — Biological and chemical indicators — Test equipment |
| ISO 20857:2010 | Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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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