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ANSI/AAMI/ISO 13408-4:2005(R2014)

Current
Current

The latest, up-to-date edition.

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

13-10-2014

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption
of ISO 13408-4:2005
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Process and equipment characterization
6 Cleaning agent characterization
7 CIP process
8 Validation
9 Routine monitoring and control
10 Personnel training
Annex A (informative) - Description of
        sampling methods
Annex B (informative) - Calculation examples
        for acceptance criteria
Bibliography

Describes the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.

Committee
WG 09
DocumentType
Standard
ISBN
1-57020-329-6
Pages
31
ProductNote
Reconfirmed 2014
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 13408-4:2005 Identical

ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software

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