Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-06-2015

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Implantable materials
5 Technical file
  5.1 Contents
  5.2 Chemical composition
  5.3 Physical properties
  5.4 Intended applications, precautions, warnings and
       instructions
  5.5 Preclinical and clinical evaluation
  5.6 Manufacture
  5.7 Materials of animal origin
  5.8 Sterilization
  5.9 Packaging
  5.10 Additional information supplied by the manufacturer
Bibliography

Pertains to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery.

This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (> 90 %) hydroxyapatite are not covered by this International Standard.

Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.

Materials such as autografts, allografts and membranes, and products for which the primary intended use is to deliver a medicinal product, are not covered by this International Standard.

Committee	CH/106/8
DevelopmentNote	Supersedes 05/30060678 DC. (08/2007) Reviewed and confirmed by BSI, June 2017. (05/2017)
DocumentType	Standard
Pages	20
PublisherName	British Standards Institution
Status	Current
Supersedes	05/30060678 DC : DRAFT SEP 2005 BS EN ISO 22794:2007

Standards	Relationship
NS EN ISO 22794 : 2009	Identical
ISO 22794:2007	Identical
EN ISO 22794:2009	Identical
NF EN ISO 22794 : DEC 2009	Identical
NBN EN ISO 22794 : 2009	Identical
SN EN ISO 22794:2010	Identical
I.S. EN ISO 22794:2009	Identical
DIN EN ISO 22794:2009-11	Identical
NEN EN ISO 22794 : 2009	Identical
UNE-EN ISO 22794:2010	Identical

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 13779-1:2008	Implants for surgery Hydroxyapatite Part 1: Ceramic hydroxyapatite
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 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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 10993-10:2010	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 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 22442-2:2015	Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 22442-3:2007	Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
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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BS EN ISO 22794:2009

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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