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About This Item

 

Full Description

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.

NOTE 2 See Annex A for guidance on Clauses 1 to 9.

ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442?3, ICH Q5A(R1) and ISO 13022.

ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
 

Document History

  1. ISO 11737-1:2018

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    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

    • Most Recent
  2. ISO 11737-1:2006


    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

    • Historical Version
  3. ISO 11737-3:2004


    Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data

    • Historical Version
  4. ISO 11737-1:1995


    Sterilization of medical devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 11737-1:2018/Amd1:2021


    - Amendment 1