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ISO 11737-1

Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of Population of Microorganisms on Products

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Organization: ISO
Publication Date: 1 February 1995
Status: inactive
Page Count: 25
ICS Code (Medical microbiology): 07.100.10
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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 estimation consists of both enumeration and characterization of the population.

NOTES

1 Prior to routine use, a technique for estimating the population of microorganisms on product is validated. The level to which identification is necessary during characterization depends on the use to be made of the data generated.

2 Annexes to this part of ISO 11737 provide guidance on selection of a technique and outline method(s) which may be used to validate the technique selected.

This part of ISO 11737 is not applicable to the enumeration or identification of viral contamination. This part of ISO 11737 is not applicable to the micro-biological monitoring of the environment in which medical devices are manufactured.

NOTE 3 Attention is drawn to the International Standards for quality systems (see ISO 9001 and ISO 9002) which control all stages of manufacture including the sterilization process. It is not a requirement of this part of ISO 11737 to have a complete quality system during manufacture, but certain elements of such a system are required and these are normatively referenced at appropriate places in the text.

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.
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,...
ISO 11737-1
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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