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  • ANSI/AAMI/ISO 13408-3:2006(R2015)

    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:  13-07-2015

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Committee WG 09
    Document Type Standard
    Product Note Reconfirmed 2015
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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