Specifies general production, labeling and performance requirements for the manufacture of biological indicators and suspensions intended for use in the validation and monitoring of sterilization cycles.
ANSI/AAMI/ISO 11138-1:2006 history
1970ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products—Biological indicators—Part 1: General requirements
2006ANSI/AAMI/ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements