ISO 11138-1
Sterilization of Health Care Products - Biological Indicators - Part 1: General First Edition
inactive
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| Organization: | ISO |
| Publication Date: | 1 January 1994 |
| Status: | inactive |
| Page Count: | 20 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
This part of ISO 11138 specifies general production, labelling and performance requirements for the manufacture of biological indicators and suspensions intended for use in the validation and monitoring of sterilization cycles.
NOTE 1 Subsequent parts of ISO 11138 specify the particular requirements for biological indicators for defined sterilization processes.
This part of ISO 11138 does not contain requirements for product directly inoculated with test organisms, or recovery procedures for such inoculated product. Nor does it specify requirements for biological indicators that use more than one strain or species of microorganism on a carrier.
Document History
March 1, 2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their...
July 1, 2006
Sterilization of health care products Biological indicators Part 1: General requirements
General
This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and...
ISO 11138-1
January 1, 1994
Sterilization of Health Care Products - Biological Indicators - Part 1: General First Edition
This part of ISO 11138 specifies general production, labelling and performance requirements for the manufacture of biological indicators and suspensions intended for use in the validation and...