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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

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

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
UNI EN 1642 : 2012 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
08/30184615 DC : DRAFT SEP 2008 BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
UNE-EN 1642:2012 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

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 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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