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  • EN 724 : 1994

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

    Available format(s): 

    Withdrawn date:  07-06-2005

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Committees responsible
    National foreword
    Foreword
    Introduction
    1. Scope
    2. Normative references
    3. 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 nonconforming 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
    Annex A (informative) Guidance on elements of quality
         systems relevant to sterile product manufacture
    Annex B (informative) Features of job descriptions
         of key individuals
    Annex C (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Gives advice on the establishment and maintenance of the quality systems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. Coverage includes: management responsibility, contract review, design control, purchasing, process control, quality records, internal quality audits, corrective action, and control of nonconforming product. Also gives detailed definitions and annexes.

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

    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Withdrawn

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

    BS EN 13795-1 : 2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
    EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    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 1174-1:1996 Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements
    BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
    I.S. CEN ISO TR 14969:2005 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
    AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
    UNI EN 13795-1 : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
    I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    CEI EN 50103 : 1996 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
    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
    BS EN 50103:1996 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
    CSA ISO TR 14969 : 2005 : R2015 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
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
    BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
    BS EN 928:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
    BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
    I.S. EN 13795-1:2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
    DIN EN 13795-1 E : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
    PD CEN ISO/TR 14969:2005 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
    PD CR 12401:2003 Dentistry. Guidance on the classification of dental devices and accessories
    DIN EN 13795-1:2009-10 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS

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

    EN 29002 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    EN 29004 : 1987 QUALITY MANAGEMENT & QUALITY SYSTEM ELEMENTS - GUIDELINES
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    EN 29001 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING
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