Dentistry - Contents of a technical file for dental implant systems
This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:
This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
This document does not apply to the following devices:
NOTE 1Â Â Â Â Â Â Â ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2Â Â Â Â Â Â Â ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3Â Â Â Â Â Â Â Custom-made devices are defined in IMDRF/PMD WG/N49 [5].
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO 10451 |
| Publication Date | Not Available |
| Language | en - English |
| Page Count | 20 |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 106/SC 8 |
Failed to load document history.
| Publish Date | Document Id | Type | View |
|---|