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About This Item

 

Full Description

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. Does not contain requirements for product directly inoculated with test organisms, or recovery procedures for such inoculated product.
 

Document History

  1. ISO 11138-1:2017


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

    • Most Recent
  2. ISO 11138-1:2006


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

    • Historical Version
  3. ISO 11138-1:1994

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

    • Historical Version