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About This Item

 

Full Description

BS EN ISO 11737-1:2018 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.


Cross References:
ISO 10012
ISO 13485
ISO 15189
ISO/IEC 17025
ISO 9001
ISO/IEC 90003
ISO 11737-2
ISO 14160
ISO 22442-3
ASTM D4855-97
ICH Q5A(R1)
ISO 17665 (all parts)
ISO 11138-2
ISO 11137 (all parts)
ISO 7870-4
ISO 13022
ISO 11139
ISO 11135
AAMI TIR37
ISO 7870-2
ISO 20857
ISO 14937
ISO 9000:2015


All current amendments available at time of purchase are included with the purchase of this document.
 

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

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

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


    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