EN ISO 22794:2009
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
- Standard No.
- EN ISO 22794:2009
- Release Date
- 2009
- Published By
- European Committee for Standardization (CEN)
- Latest
- EN ISO 22794:2009
- Replace
- BS EN ISO 22794:2007
- Scope
- 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 byThis International Standard.
EN ISO 22794:2009 Referenced Document
- EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
- ISO 11134 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
- ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
- ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
- ISO 11607:2003 Packaging for terminally sterilized medical devices
- ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
- ISO 14155:1996 Clinical investigation of medical devices
- ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
- ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
- ISO 1942 Dentistry — Vocabulary — Amendment 1
EN ISO 22794:2009 history
- 2009 EN ISO 22794:2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
- 2007 EN ISO 22794:2007 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
EN ISO 22794:2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file has been changed from BS EN ISO 22794:2007 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file.
