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Norm
ÖNORM EN ISO 10451
Issue date: 2010 09 01
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
This International Standard specifies requirements for the contents of a technical file to demonstrate the
fulfilment of regulatory requirements for a dental implant and...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 10451
2010 09 01
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
Norm
↖
ÖNORM EN ISO 10451
2002 07 01
Dental implant systems - Contents of technical file (ISO 10451:2002)
Norm
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2006 04 19
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2006 04 19
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2006 04 07
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ISO 11607-2:2006
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2006 04 07
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ISO 14155-1:2003
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2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
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ISO 14155-2:2003
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2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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ISO 14801:2007
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2007 11 06
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ISO 14937:2009
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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
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2005 09 19
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ISO 129-1:2018
Issue date :
2018 02 23
Technical product documentation (TPD) — Presentation of dimensions and tolerances — Part 1: General principles
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ISO 7405:2018
Issue date :
2018 10 15
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry (Corrected version 2018-11)
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ISO 10993-7:2008
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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ISO 10993-9:2019
Issue date :
2019 11 26
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
Norm
ISO 11135-1:2007
Issue date :
2007 04 27
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Corrected version 2007-10)
Technische Regel
ISO/TS 11135-2:2008
Issue date :
2008 07 17
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1
Norm
ISO 11137-1:2006
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11137-2:2013
Issue date :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 11137-3:2017
Issue date :
2017 06 26
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
Norm
ISO 11607-1:2019
Issue date :
2019 01 31
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Norm
ISO 11607-2:2019
Issue date :
2019 01 31
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Norm
ISO 14155-1:2003
Issue date :
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Norm
ISO 14155-2:2003
Issue date :
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Norm
ISO 14405-2:2018
Issue date :
2018 12 14
Geometrical product specifications (GPS) — Dimensional tolerancing — Part 2: Dimensions other than linear or angular sizes
Norm
ISO 14801:2016
Issue date :
2016 10 24
Dentistry — Implants — Dynamic loading test for endosseous dental implants
Norm
ISO 14937:2009
Issue date :
2009 10 14
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
Norm
ISO 14971:2019
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
ISO 17664:2017
Issue date :
2017 10 25
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
Norm
ISO 17665-1:2006
Issue date :
2006 08 17
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Technische Regel
ISO/TS 22911:2016
Issue date :
2016 07 11
Dentistry — Preclinical evaluation of dental implant systems — Animal test methods
Norm
ISO 10451:2010
Issue date :
2010 06 07
Dentistry — Contents of technical file for dental implant systems