BS EN ISO 10451:2010
Current
The latest, up-to-date edition.
Dentistry. Contents of technical file for dental implant systems
Hardcopy , PDF
English
07-31-2010
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Bibliography
Defines requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof which remains in the mouth after surgery.
| Committee |
CH/106
|
| DevelopmentNote |
Supersedes 00/563926 DC. (05/2002) Supersedes 09/30180393 DC. (08/2010)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.
This International Standard is not applicable to instruments and other parts specifically made for the dental implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.
| Standards | Relationship |
| ISO 14229-3:2012 | Identical |
| UNE-EN ISO 10451:2010 | Identical |
| NEN EN ISO 10451 : 2010 | Identical |
| NS EN ISO 10451 : 2010 | Identical |
| EN ISO 10451:2010 | Identical |
| NF EN ISO 10451 : 2010 | Identical |
| I.S. EN ISO 10451:2010 | Identical |
| ISO 10451:2010 | Identical |
| NBN EN ISO 10451 : 2010 | Identical |
| DIN EN ISO 10451:2010-11 | Identical |
| SN EN ISO 10451 : 2010 | Identical |
| UNI EN ISO 10451 : 2010 | Identical |
| ISO 6507-1:2005 | Metallic materials Vickers hardness test Part 1: Test method |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 6892-1:2016 | Metallic materials Tensile testing Part 1: Method of test at room temperature |
| ISO 5832-3:2016 | Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 13356:2015 | Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 6474-1:2010 | Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 1942:2009 | Dentistry Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 5832-2:1999 | Implants for surgery Metallic materials Part 2: Unalloyed titanium |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 129-1:2004 | Technical drawings Indication of dimensions and tolerances Part 1: General principles |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 14801:2016 | Dentistry Implants Dynamic loading test for endosseous dental implants |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 178:2010 | Plastics Determination of flexural properties |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 22911:2016 | Dentistry Preclinical evaluation of dental implant systems Animal test methods |
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