EN ISO 10451:2010
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
Published date
15-06-2010
Publisher
Withdrawn date
31-12-2010
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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 |
Withdrawn
|
| 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 |
Summarise
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