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  • 09/30180393 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-07-2010

    Language(s):  English

    Published date: 

    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
       4.1 General
       4.2 Intended use
       4.3 Design characteristics
       4.4 Properties of the constituent materials
       4.5 Properties of the final product
       4.6 Reference to previous generation(s) or similar
            devices
       4.7 Risk assessment
       4.8 Control of infection and microbial contamination
       4.9 Biological evaluation
       4.10 Clinical evaluation
       4.11 Manufacturing process
       4.12 Quality control of the implant manufacturing process
       4.13 Packaging
            4.13.1 Primary container
            4.13.2 Protection from damage in storage and transport
       4.14 Label
       4.15 Instructions for use
    Bibliography

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

    Comment Closes On
    Committee CH/106/8
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    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 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 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 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 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 14801:2016 Dentistry Implants Dynamic loading test for endosseous dental implants
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    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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