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  • CR 12401 : 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES

    Available format(s): 

    Superseded date:  01-07-2003

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Classification of dental devices and accessories
    3 Proposals for classification of dental devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidelines on the application of classification rules in Council Directive 93/42 EEC of 14 June 1993 relevant to medical devices as they apply to dental devices and accessories.

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

    Committee TC 55
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    02/563808 DC : DRAFT SEP 2002 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    02/563845 DC : DRAFT SEP 2002 BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
    05/30099256 DC : DRAFT MAY 2005 ISO 16059 - DENTISTRY - REQUIRED ELEMENTS FOR CODIFICATION USED IN DATA EXCHANGE
    02/563832 DC : DRAFT SEP 2002 BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
    ISO/TR 15300:2001 Dentistry Application of OSI clinical codification to the classification and coding of dental products
    02/563818 DC : DRAFT SEP 2002 BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT

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

    EN 21942-1 : 1991 DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
    EN 21942-2 : 1992 DENTAL VOCABULARY - DENTAL MATERIALS
    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    EN ISO 13488 : 2000 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    EN 21942-4 : 1993 DENTAL VOCABULARY - DENTAL EQUIPMENT
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
    EN ISO 7405:2008/A1:2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
    EN 21942-3 : 1993 DENTAL VOCABULARY - DENTAL INSTRUMENTS
    EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
    EN 1642:2011 Dentistry - Medical devices for dentistry - Dental implants
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
    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
    ISO 1942-5:1989 Dental vocabulary Part 5: Terms associated with testing
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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