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Full Description

This part of ISO 11138 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.
 

Document History

  1. CAN/CSA-ISO 11138-1:17 (R2022)


    Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements (Adopted ISO 11138-1:2017, third edition, 2017-03)

    • Most Recent
  2. CAN/CSA Z11138-1-07 (R2016)

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    Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements (Adopted ISO 11138-1:2006, second edition, 2006-07-01)

    • Historical Version