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  • BS EN ISO 10451:2010

    Current The latest, up-to-date edition.

    Dentistry. Contents of technical file for dental implant systems

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-07-2010

    Publisher:  British Standards Institution

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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

    Abstract - (Show below) - (Hide below)

    Defines requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof which remains in the mouth after surgery.

    Scope - (Show below) - (Hide below)

    This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.

    This International Standard is not applicable to instruments and other parts specifically made for the dental implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.

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

    Committee CH/106/8
    Development Note Supersedes 00/563926 DC. (05/2002) Supersedes 09/30180393 DC. (08/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 6507-1:2005 Metallic materials Vickers hardness test Part 1: Test method
    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
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 6892-1:2016 Metallic materials Tensile testing Part 1: Method of test at room temperature
    ISO 5832-3:2016 Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 13356:2015 Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
    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 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 1942:2009 Dentistry Vocabulary
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    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 9001:2015 Quality management systems — Requirements
    ISO 129-1:2004 Technical drawings Indication of dimensions and tolerances Part 1: General principles
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 14801:2016 Dentistry Implants Dynamic loading test for endosseous dental implants
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    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 178:2010 Plastics Determination of flexural properties
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO/TS 22911:2016 Dentistry Preclinical evaluation of dental implant systems Animal test methods
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