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  • EN ISO 14727:1998/AC:1998

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE

    Available format(s): 

    Withdrawn date:  07-06-2005

    Language(s): 

    Published date:  11-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    Bibliography
    Annex ZA (normative) Normative references to international
                         publications with their relevant European
                         publications

    Abstract - (Show below) - (Hide below)

    Defines the requirements for the contents of a technical file for prefabricated parts connecting a dental suprastructure to a transgingival dental implant. Applicable to all parts providing functional load transfer from a suprastructure to a dental implant, excluding custom-made devices for the same purpose.

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

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    Status Withdrawn

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

    02/563845 DC : DRAFT SEP 2002 BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS

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

    ISO 6507-1:2005 Metallic materials Vickers hardness test Part 1: Test method
    EN 21942-1 : 1991 DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
    ISO 6892:1998 Metallic materials Tensile testing at ambient temperature
    ISO 1942-1:1989 Dental vocabulary Part 1: General and clinical terms
    EN 540 : 1993 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 406:1987 Technical drawings Tolerancing of linear and angular dimensions
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 5832-2:1999 Implants for surgery Metallic materials Part 2: Unalloyed titanium
    ISO 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
    ISO 9001:2015 Quality management systems — Requirements
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    ISO 178:2010 Plastics Determination of flexural properties
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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