BS EN ISO 22794:2009
Current
The latest, up-to-date edition.
Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file
Hardcopy , PDF
English
06-30-2015
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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.
| Committee |
CH/106
|
| 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 |
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.
| 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/IEC 15504-4:2004 | 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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