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.
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Informaciones generales
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Estado: PublicadoFecha de publicación: 2021-03Etapa: Norma Internacional en proceso de revisión sistemática [90.20]
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Edición: 1Número de páginas: 13
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Comité Técnico :ISO/TC 198
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