ISO 10451:2010
Dentistry - Contents of technical file for dental implant systems

Standard No.

ISO 10451:2010

Release Date

2010

Published By

International Organization for Standardization (ISO)

Latest

ISO 10451:2010

Scope

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.

ISO 10451:2010 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
• ISO 129-1 Technical product documentation (TPD) — Presentation of dimensions and tolerances — Part 1: General principles — Amendment 1*， 2020-03-09 Update
• ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
• ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
• ISO 14405-2 Geometrical product specifications (GPS) — Dimensional tolerancing — Part 3: Angular sizes*， 2018-12-14 Update
• ISO 14801 Dentistry - Implants - Dynamic loading test for endosseous dental implants*， 2016-11-01 Update
• ISO 14937 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 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
• ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*， 2017-09-30 Update
• ISO 17665-1 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 1942 Dentistry — Vocabulary — Amendment 1
• ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry*， 2018-10-01 Update
• ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
• ISO/TS 11135-2 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1; Technical Corrigendum 1

ISO 10451:2010 history

• 2010 ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems
• 2002 ISO 10451:2002 Dental implant system - Contents of technical file