ISO 22794:2007
Current
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
Available format(s)
Hardcopy , PDF
Language(s)
English, French
Published date
02-07-2007
€63.00
Excluding VAT
ISO 22794:2007 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 (greater than 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.
| Committee |
ISO/TC 106/SC 8
|
| DevelopmentNote |
Supersedes ISO/DIS 22794. (07/2007)
|
| DocumentType |
Standard
|
| Pages |
10
|
| ProductNote |
THIS STANDARD IS ALSO HAVE CORRECTED VERSION OF (en) : 2009-01
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NBN EN ISO 22794 : 2009 | Identical |
| NEN EN ISO 22794 : 2009 | Identical |
| NS EN ISO 22794 : 2009 | Identical |
| I.S. EN ISO 22794:2009 | Identical |
| PN EN ISO 22794 : 2010 | Identical |
| BS EN ISO 22794:2009 | Identical |
| EN ISO 22794:2009 | Identical |
| DIN EN ISO 22794:2009-11 | Identical |
| NF EN ISO 22794 : DEC 2009 | Identical |
| IS 17697 : 2021 | Identical |
| UNE-EN ISO 22794:2007 | Identical |
| UNE-EN ISO 22794:2010 | Identical |
| BS EN ISO 22794:2007 | Identical |
| DIN EN 1642:2012-06 | 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 |
| BS EN 1642:2011 | Dentistry. Medical devices for dentistry. Dental implants |
| UNE-EN 1642:2012 | Dentistry - Medical devices for dentistry - Dental implants |
| 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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