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EN ISO 22803:2005

Current
Current

The latest, up-to-date edition.

Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
Published date

02-11-2005

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General description
5 Contents of a technical file
Bibliography

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 useda) 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.

Committee
CEN/TC 55
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

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
08/30184615 DC : DRAFT SEP 2008 BS EN 1642 - 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

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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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