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  • CEI EN 50103 : 1996

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  01-07-2020

    Language(s):  English - Italian

    Published date:  01-01-1996

    Publisher:  Comitato Elettrotecnico Italiano

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

    INTRODUCTION
    1 SCOPE
    2 NORMATIVE REFERENCES
    3 TERMINOLOGY AND DEFINITIONS
    4 GUIDANCE ON QUALITY SYSTEM REQUIREMENTS
    ANNEX A informative - TERMINOLOGY - INDEX OF TERMS
    ANNEX B informative - BIBLIOGRAPHY

    Abstract - (Show below) - (Hide below)

    Defines concepts and objectives which should be considered by a SUPPLIER of ACTIVE MEDICAL DEVICES while developing and maintaining his QUALITY SYSTEM.

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

    Committee CT 62
    Development Note Classificazione CEI 62-72 (09/2001)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Withdrawn

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

    EN 29002 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    ISO 9004-2:1991 Quality management and quality system elements Part 2: Guidelines for services
    ISO 9000-2:1997 Quality management and quality assurance standards — Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 9001:2015 Quality management systems — Requirements
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    EN 29004-2:1993/AC:1997 QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - GUIDELINES FOR SERVICES
    EN 29000-3 : 1993 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - GUIDELINES FOR THE APPLICATION OF ISO 9001 TO THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE
    ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
    UNI EN 29001 : 1988
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    EN 29001 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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