UNE-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
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 moist heat as the sterilizing agent.Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.NOTE 1Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665.NOTE 2National or regional regulations may provide requirements for work place safety.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 866-3 & UNE EN 866-7. (04/2007)
|
| DocumentType |
Standard
|
| Pages |
19
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| 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 |
| NS EN ISO 11138-3 : 2017 | Identical |
| BS 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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