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  • PD CR 12401:2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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):  Hardcopy, PDF

    Superseded date:  30-06-2009

    Language(s):  English

    Published date:  14-08-2003

    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
    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 CH/106
    Development Note Supersedes BS PD6618(1997). (02/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    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
    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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