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  • PD CEN/TR 12401:2009

    Current The latest, up-to-date edition.

    Dentistry. Guidance on the classification of dental devices and accessories

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-06-2009

    Publisher:  British Standards Institution

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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
      and accessories
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance on the application of the classification rules in Council Directive 93/42/EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.

    Scope - (Show below) - (Hide below)

    This CEN Technical Report provides guidance on the application of the classification rules in Council Directive 93/42 EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.

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

    Committee CH/106
    Development Note Supersedes BS PD CR 12401. (06/2009)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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
    EN 21942-4 : 1993 DENTAL VOCABULARY - DENTAL EQUIPMENT
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    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
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    ISO 1942-5:1989 Dental vocabulary Part 5: Terms associated with testing
    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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