International Standard
ISO/TS 22456:2021
Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Reference number
ISO/TS 22456:2021
Edición 1
2021-03
International Standard
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ISO/TS 22456:2021
73256
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Publicado (Edición 1, 2021)

ISO/TS 22456:2021

ISO/TS 22456:2021
73256
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CHF 96
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2021-03
    : Norma Internacional en proceso de revisión sistemática [90.20]
  •  : 1
     : 13
  • ISO/TC 198
  • RSS actualizaciones

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