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  • EN 46002 : 1996

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002

    Available format(s): 

    Superseded date:  25-10-2000

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Cooperating organizations
    National foreword
    Foreword
    0. Introduction
    1. Scope and field of application
    2. Normative references
    3. Definitions
    4. Quality system requirements
    4.1 Management responsibility
    4.2 Quality system
    4.3 Contract review
    4.4 Document control
    4.5 Purchasing
    4.6 Purchaser supplied product
    4.7 Product identification and traceability
    4.8 Process control
    4.9 Inspection and testing
    4.10 Inspection, measuring and test equipment
    4.11 Inspection and test status
    4.12 Control of nonconforming product
    4.13 Corrective action
    4.14 Handling, storage, packaging and delivery
    4.15 Quality records
    4.16 Internal quality audits
    4.17 Training
    4.18 Statistical techniques
    Annex A (informative) - Bibliography
    National annex NA (informative) Committees responsible
    National annex NB (informative) Cross-references

    Abstract - (Show below) - (Hide below)

    Specifies the quality requirements for the production and, where relevant, installation of medical devices. Coverage includes: quality system requirements; product identification and traceability; inspection, measuring and test equipment; control of nonconforming product; handling, storage, packaging and delivery; internal quality audits. Also gives detailed definitions.

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

    Committee CEN/CLC CWG/QS
    Development Note Renumbered to EN ISO 13488 (05/2001)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    I.S. EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS
    I.S. EN 12022:1999 BLOOD GAS EXCHANGERS
    CR 14060:2000 Medical device traceability
    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 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    EN 12022 : 1999 BLOOD GAS EXCHANGERS
    CR 12401 : 1996 DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES
    EN 1283 : 1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
    I.S. EN 12442-3:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    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
    I.S. EN 12442-2:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
    03/317861 DC : DRAFT OCT 2003 EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
    BS EN 12022:1999 Blood-gas exchangers
    BS EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling
    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
    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
    BS EN 46003:1999 Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003
    BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\'
    BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
    BS EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
    BS EN 12523:1999 External limb prostheses and external orthoses. Requirements and test methods
    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
    EN 928 : 1995 IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 12322:1999/A1:2001 IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY - PERFORMANCE CRITERIA FOR CULTURE MEDIA
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    S.R. CR 14060:2000 MEDICAL DEVICE TRACEABILITY
    PD CR 12401:2003 Dentistry. Guidance on the classification of dental devices and accessories
    BS EN 12322:1999 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
    BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods
    EN 12523 : 1999 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
    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 ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    EN ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
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