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A new version of EN ISO 11737-2 on tests of sterility was published as BS EN ISO 11737-2:2020 in May. Some changes parallel those incorporated in EN ISO 11737-1. Others include adding requirements that:

  • the interval between manufacturing the device and sterilizing it reflects routine processing timelines; and
  • product remains immersed in the culture media

In addition, guidance has been added on:

  • controlling the environment for performing tests of sterility;
  • identifying the microorganism when microbial growth is detected in a test of sterility; and
  • demonstrating ongoing method suitability periodically to ensure that an accumulation of minor changes has not occurred over time

New work has started to prepare EN ISO 11737-3 on bacterial endotoxin testing. This will specify general criteria for determination of bacterial endotoxins on or in raw materials, components or health care products. It applies to use of bacterial endotoxin test methods with amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. It is not applicable to the evaluation of pyrogens other than bacterial endotoxin and does not include other endotoxin detection methodologies such as monocyte activation and recombinant Factor C.

Click on the link below to access: Sterilization – Regulatory requirements and supporting standards Authored by – Eamonn Hoxey, technical author, trainer and consultant

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