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About This Item

 

Full Description

BS EN ISO 11737-1:2006 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.

BS EN ISO 11737-1:2006 does not specify requirements for the enumeration or identification of viral or protozoan contaminants.

NOTE 2 Furthermore, the requirements specified in BS EN ISO 11737-1:2006 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.

BS EN ISO 11737-1:2006 does not specify requirements for the microbiological monitoring of the environment in which medical devices are manufactured.



Cross References:
ISO 10012
ISO 13485:2003
ISO/IEC 17025:2005
ISO/TR 7871:1997
ISO 8258:1991
ISO 9000:2005
ISO 17665-1
ISO 11137-1
ISO 11137-2
ISO 11137-3
ISO 11138-2
ISO/TS 11139:2006
ISO 11737-2
ISO 14160:1998
ISO 14937:2000
ISO 90003:2004
ISO 9001:2000
ASTM D4855:1997
90/385/EEC
93/42/EEC
98/79/EC
 

Document History

  1. BS EN ISO 11737-1:2018+A1:2021


    Sterilization of health care products. Microbiological methods-Determination of a population of microorganisms on products

    • Most Recent
  2. BS EN ISO 11737-1:2018


    Sterilization of health care products. Microbiological methods-Determination of a population of microorganisms on products

    • Historical Version
  3. BS EN ISO 11737-1:2006

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    Sterilization of medical devices. Microbiological methods-Determination of a population of microorganisms on products

    • Historical Version
  4. BS EN 1174-3:1997


    Sterilization of medical devices. Estimation of the population of micro-organisms on product-Guide to the methods for validation of microbiological techniques

    • Historical Version
  5. BS EN 1174-2:1997


    Sterilization of medical devices. Estimation of the population of micro-organisms on product-Guidance

    • Historical Version
  6. BS EN 1174-1:1996


    Sterilization of medical devices. Estimation of the population of micro-organisms on product-Requirements

    • Historical Version