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  • ISO 22803:2004

    Current The latest, up-to-date edition.

    Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file

    Available format(s):  PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  03-09-2004

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used

    a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,

    b) in contact with teeth and/or dental implants,

    c) for prevention of epithelial migration in periodontal surgery,

    d) for the augmentation of bone prior to the planned insertion of dental implants,

    e) and/or for augmentation of bone for stabilization of dental prostheses.

    This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.

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

    Committee ISO/TC 106/SC 8
    Development Note Supersedes ISO/DIS 22803 (09/2004)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

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

    DIN EN 1642:2012-06 Dentistry - Medical devices for dentistry - Dental implants
    I.S. EN 1642:2011 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
    UNI EN 1642 : 2012 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
    UNE-EN 1642:2012 Dentistry - Medical devices for dentistry - Dental implants
    EN 1642:2011 Dentistry - Medical devices for dentistry - Dental implants
    BS EN 1642:2011 Dentistry. Medical devices for dentistry. Dental implants

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

    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    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 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 1942-1:1989 Dental vocabulary Part 1: General and clinical terms
    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 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/TR 14283:2004 Implants for surgery Fundamental principles
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 1942:2009 Dentistry Vocabulary
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    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 11607:2003 Packaging for terminally sterilized medical devices
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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