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API STD 521: Guide for Pressure-relieving and Depressuring Systems – Edition 6

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ISO 22456:2021

ISO 22456:2021 Sterilization of healthcare products – Microbiological methods- Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

CDN $186.00

SKU: 33aeb37d974f Categories: ,

Description

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.

Edition

1

Published Date

2021-03-19

Status

PUBLISHED

Pages

13

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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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