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ANSI/AAMI/ISO 13408-2:2018

Current

Current

The latest, up-to-date edition.

Aseptic processing of health care products—Part 2: Sterilizing filtration

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-02-2018

€127.50
Excluding VAT

This document specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1.

Committee
TC 198
DocumentType
Guide
ISBN
978-1-57020-696-2
Pages
45
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 13408-2:2018 Identical

ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ISO 13408-3:2006 Aseptic processing of health care products — Part 3: Lyophilization
ISO 10993-12:2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO/IEC 90003:2014 Software engineering — Guidelines for the application of ISO 9001:2008 to computer software
ISO 13408-6:2005 Aseptic processing of health care products — Part 6: Isolator systems
ISO 11737-1:2018 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

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€127.50
Excluding VAT