EN ISO 10451:2010
Current
Current
The latest, up-to-date edition.
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
Published date
15-06-2010
Publisher
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Bibliography
ISO 10451:2010 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.
| Committee |
CEN/TC 55
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| NEN EN ISO 10451 : 2010 | Identical |
| NS EN ISO 10451 : 2010 | Identical |
| BS 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 |
| PN EN ISO 10451 : 2010 | Identical |
| DS EN ISO 10451 : 2010 | Identical |
| UNE-EN ISO 10451:2010 | Identical |
| 02/563845 DC : DRAFT SEP 2002 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| DIN EN 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
| I.S. EN 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| 08/30184615 DC : DRAFT SEP 2008 | BS EN 1642 - 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 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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