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  • EN ISO 22803 : 2005

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    DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE (ISO 22803:2004)

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    Language(s): 

    Published date:  02-11-2005

    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 General description
    5 Contents of a technical file
    Bibliography

    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.

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

    Committee CEN/TC 55
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

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

    08/30184615 DC : DRAFT SEP 2008 BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
    DIN EN 1642:2012-06 Dentistry - Medical devices for dentistry - Dental implants
    BS EN 1642 : 2011 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
    UNE-EN 1642:2012 Dentistry - Medical devices for dentistry - Dental implants
    I.S. EN 1642:2011 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
    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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