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  • BS 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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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    Withdrawn date:  05-08-2008

    Language(s):  English

    Published date:  15-03-1996

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1. Scope
    2. Normative references
    3. Terminology and definitions
    3.1 Terminology
    3.2 Definitions
    4. Guidance on QUALITY SYSTEM requirements
    4.1 Management responsibility
    4.2 QUALITY SYSTEM
    4.3 Contract review
    4.4 Design control
    4.5 Document control
    4.6 Purchasing
    4.7 PURCHASER supplied PRODUCT
    4.8 PRODUCT identification and traceability
    4.9 Process control
    4.10 INSPECTION AND TESTING
    4.11 INSPECTION, measuring and test equipment
    4.12 INSPECTION and test status
    4.13 Control of non-conforming PRODUCT
    4.14 CORRECTIVE ACTION
    4.15 Handling, storage, packaging and delivery
    4.16 Quality records
    4.17 Internal QUALITY AUDITS
    4.18 Training
    4.19 Servicing
    4.20 Statistical techniques
    Annexes
    A. (informative) Terminology - Index of terms
    B. (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Contains guidelines for suppliers of active medical devices (including active implantable medical devices) who wish to ensure that they comply with EN 46001.

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

    Committee CH/210/1
    Development Note Supersedes 92/52897 DC. (09/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Supersedes

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

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    BS EN ISO 9001:2015 Quality management systems. Requirements
    EN 540 : 1993 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
    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
    BS EN 46002:1997 Specification for application of EN ISO 9002 to the manufacture of medical devices
    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    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
    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
    BS EN ISO 9002:1994 Quality systems. Model for quality assurance in production, installation and servicing
    BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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