Name: UNI EN ISO 10451 : 2010
Brand: UNI

DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS

Published date

05-08-2010

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Bibliography

Describes 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	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN ISO 10451 : 2002

Standards	Relationship
UNE-EN ISO 10451:2010	Identical
NEN EN ISO 10451 : 2010	Identical
NS EN ISO 10451 : 2010	Identical
BS EN ISO 10451:2010	Identical
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
SN EN ISO 10451 : 2010	Identical

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