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  • NBN EN ISO 11607-2 : 2006 AMD 1 2014

    Current The latest, up-to-date edition.

    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006/AMD 1:2014)

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    Language(s): 

    Published date:  12-01-2013

    Publisher:  Belgian Standards

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
      4.1 Quality systems
      4.2 Sampling
      4.3 Test methods
      4.4 Documentation
    5 Validation of packaging processes
      5.1 General
      5.2 Installation qualification (IQ)
      5.3 Operational qualification (OQ)
      5.4 Performance qualification (PQ)
      5.5 Formal approval of the process validation
      5.6 Process control and monitoring
      5.7 Process changes and revalidation
    6 Packaging system assembly
    7 Use of reusable sterile barrier systems
    8 Sterile fluid-path packaging
    Annex A (informative) - Process development
    Annex ZA (informative) - Relationship between this International
                             Standard and the Essential Requirements
                             of EU Directive 93/42/EEC on medical
                             devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized, it includes forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

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    Document Type Standard
    Publisher Belgian Standards
    Status Current
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