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ISO 11737-1

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

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Organization: ISO
Publication Date: 1 April 2006
Status: inactive
Page Count: 42
ICS Code (Medical microbiology): 07.100.10
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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.

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

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

NOTE 2 Furthermore, the requirements specified in this part of ISO 11737 are not intended to address the removal and detection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

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

Document History

May 1, 2021
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products AMENDMENT 1
A description is not available for this item.
January 1, 2018
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
This document 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...
May 15, 2007
Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products TECHNICAL CORRIGENDUM 1
A description is not available for this item.
ISO 11737-1
April 1, 2006
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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,...
February 1, 1995
Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of Population of Microorganisms on Products
This part of ISO 11737 specifies general criteria to be applied in the estimation of the population of viable microorganisms on a medical device or component, raw material or package thereof. This...

References

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