Skip to content
Please enter a keyword to search

  • EN 50103 : 1995

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

    Withdrawn date:  31-01-2008

    Language(s): 

    Published date:  12-01-2013

    Publisher:  European Committee for Standards - Electrical

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    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 TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Withdrawn

    Standards Referenced By This Book - (Show below) - (Hide below)

    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    CR 12401 : 1996 DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES
    CEI UNI EN 46003 : 2001 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003
    BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
    AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    BS EN 46003:1999 Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003
    CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
    PD CR 12401:2003 Dentistry. Guidance on the classification of dental devices and accessories

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

    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    ISO 9001:2015 Quality management systems — Requirements
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective