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  • EN 46001 : 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9001

    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    Superseded date:  25-10-2000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)

    Foreword
    0 Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Quality system requirements
       4.1 Management responsibility
       4.2 Quality system
       4.3 Contract review
       4.4 Design control
       4.5 Document and data control
       4.6 Purchasing
       4.7 Control of customer-supplied product
       4.8 Product identification and traceability
       4.9 Process control
       4.10 Inspection and testing
       4.11 Control of inspection, measuring and test equipment
       4.12 Inspection and test status
       4.13 Control of nonconforming product
       4.14 Corrective and preventive action
       4.15 Handling, storage, packaging, preservation and delivery
       4.16 Control of quality records
       4.17 Internal quality audits
       4.18 Training
       4.19 Servicing
       4.20 Statistical techniques
    Annex A (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.

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

    Committee TC 205, TC 62 & ýTC 140
    Development Note To be read in conjunction with EN ISO 9001. (07/2003) Supersedes ENV 50076. (08/2005)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By
    Supersedes

    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
    DIN EN 737-3:1998-11 MEDICAL GAS PIPELINE SYSTEMS - PART 3: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
    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
    99/124125 DC : DRAFT NOV 1999 BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS
    CEI UNI EN 46003 : 2001 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003
    DIN EN 737-3:2000-01 MEDICAL GAS PIPELINE SYSTEMS - PART 3: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
    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
    I.S. EN 737-3:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
    03/317861 DC : DRAFT OCT 2003 EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
    CSA Z7396.2 : 2002 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
    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 13612:2002 Performance evaluation of in vitro diagnostic medical devices
    BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\'
    BS EN 737-3:2000 Medical gas pipeline systems Pipelines for compressed medical gases and vacuum
    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 737-2:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS
    EN 737-3:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
    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
    I.S. EN 737-2:1998 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS
    02/121895 DC : DRAFT APR 2002 BS EN 13060 - SMALL STEAM STERILIZERS
    S.R. CR 14060:2000 MEDICAL DEVICE TRACEABILITY
    PD CR 12401:2003 Dentistry. Guidance on the classification of dental devices and accessories
    AAMI QSR : 1996 QUALITY SYSTEM REGULATION (21 CFR PARTS 808, 812 AND 820) - OCTOBER 1996
    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
    EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS

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

    BS EN ISO 9001:2015 Quality management systems. Requirements
    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 ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    EN 50103 : 1995 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
    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 ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
    BS EN ISO 8402:1995 Quality management and quality assurance. Vocabulary
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