UNE-EN ISO 11138-1:2017
Current
The latest, up-to-date edition.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
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Spanish, Castilian, English
08-11-2017
1.1General1.1.1This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.1.1.2This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.NOTENational or regional regulations may apply.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 866-1. (05/2007)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| NS EN ISO 11138-1 : 2017 | Identical |
| ISO 11138-1:2017 | Identical |
| BS EN ISO 11138-1:2017 | Identical |
| NF EN ISO 11138-1 : 2017 | Identical |
| NBN EN ISO 11138-1 : 2006 | Identical |
| EN ISO 11138-1:2017 | Identical |
| I.S. EN ISO 11138-1:2017 | Identical |
| NEN EN ISO 11138-1 : 2017 | Identical |
| DIN EN ISO 11138-1:2015-10 (Draft) | Identical |
| DIN EN ISO 11138-1:2017-07 | Equivalent |