Abstract Preview

1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization.

NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2.

1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.


General information

  • Status :  Published
    Publication date : 2021-03
  • Edition : 1
    Number of pages : 13
  • :
    ISO/TC 198
    Sterilization of health care products
  • 07.100.10
    Medical microbiology
    11.080.01
    Sterilization and disinfection in general

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