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ANSI/AAMI/ISO 13408-3:2006(R2015)

Current
Current

The latest, up-to-date edition.

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-13-2015

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 13408-3:2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Product definition
6 Process definitions
7 User requirements
8 Validation
9 Routine monitoring and control
Bibliography

Describes requirements for, and offers guidance on, equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process.

Committee
WG 09
DocumentType
Standard
ISBN
1-57020-328-8
Pages
24
ProductNote
Reconfirmed 2015
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 13408-3:2006 Identical

ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place

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