RO
SR EN ISO 11138-1:2007
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
ISO 11138-1:2006 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.ISO 11138-1:2006 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.
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Status :
Withdrawn
Approval date : 1/30/2007
Publish date : 2/1/2007
Withdrawal date : 8/31/2017
Number of pages : 44
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN 866-1:2004
- Normative reference SR EN ISO 11607-1:2006
- Normative reference SR EN ISO 13485:2004
- Normative reference SR ISO 15223:2002
- Normative reference SR EN ISO 11737-1:2006
- Normative reference SR EN ISO 11607-2:2006
- Normative reference SR EN ISO 18472:2006
- Normative reference SR EN 550:1997
- Normative reference SR EN ISO 11137-3:2006
- Normative reference SR EN ISO 11137-1:2006
- Replaced by SR EN ISO 11138-1:2017