• UNE-EN 1642:2012

    Current The latest, up-to-date edition.

    Dentistry - Medical devices for dentistry - Dental implants

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  22-02-2012

    Publisher:  Asociacion Espanola de Normalizacion

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    Committee CTN 106
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    EN ISO 14801:2016 DENTISTRY - IMPLANTS - DYNAMIC LOADING TEST FOR ENDOSSEOUS DENTAL IMPLANTS (ISO 14801:2016)
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    EN 21942-1 : 1991 DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN 21942-2 : 1992 DENTAL VOCABULARY - DENTAL MATERIALS
    EN ISO 22803:2005 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 1942-1:1989 Dental vocabulary Part 1: General and clinical terms
    EN ISO 22794:2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 1942-2:1989 Dental vocabulary Part 2: Dental materials
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 10451:2010 Dentistry — Contents of technical file for dental implant systems
    EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    EN ISO 7405:2008/A1:2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
    CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 3950:2016 Dentistry — Designation system for teeth and areas of the oral cavity
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
    ISO 22794:2007 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 1942-5:1989 Dental vocabulary Part 5: Terms associated with testing
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14801:2016 Dentistry Implants Dynamic loading test for endosseous dental implants
    EN ISO 3950:2016 Dentistry - Designation system for teeth and areas of the oral cavity (ISO 3950:2016)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 22803:2004 Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file
    EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
    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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