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ISO 11737-1

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

active, Most Current
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Organization: ISO
Publication Date: 1 January 2018
Status: active
Page Count: 58
ICS Code (Medical microbiology): 07.100.10
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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 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.

This document 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.

This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Document History

July 2, 2020
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.
ISO 11737-1
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.
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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