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About This Item

 

Full Description

This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package.

This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoan contaminants.

This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment in which medical devices are manufactured.

 

Document History

  1. ISO 11737-1:2018


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

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  2. ISO 11737-1:2006

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

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  3. 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/Cor1:2007

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