Standard Swedish standard · SS-EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

Status: Withdrawn

· Replaced by: SS-EN ISO 11737-1:2018 Corrected by: SS-EN ISO 11737-1:2006/AC:2009
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Standard Swedish standard · SS-EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
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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.

Subjects

Medical microbiology (07.100.10) Sterilization and disinfection in general (11.080.01)


Buy this standard

Standard Swedish standard · SS-EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
Subscribe on standards - Read more Dölj
Price: 1 320 SEK
standard ikon pdf

PDF

Price: 1 320 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-45076

Edition: 1

Approved: 4/12/2006

No of pages: 42

Replaces: SS-EN 1174-1 , SS-EN 1174-2 , SS-EN 1174-3

Replaced by: SS-EN ISO 11737-1:2018