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About This Item

 

Full Description

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.
 

Document History

  1. AAMI/ISO 11138-1:2017/(R)2024


    Sterilization of health care products - Biological indicators - Part 1: General requirements

    • Most Recent
  2. AAMI/ISO 11138-1:2006/(R)2015


    Sterilization of health care products - Biological indicators - Part 1: General requirements

    • Historical Version
  3. AAMI ST59-99

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    Sterilization of Health Care Products - Biological Indicators - Part 1: General

    • Historical Version