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09/30180393 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
Available format(s)

Hardcopy , PDF

Superseded date

07-31-2010

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
   4.1 General
   4.2 Intended use
   4.3 Design characteristics
   4.4 Properties of the constituent materials
   4.5 Properties of the final product
   4.6 Reference to previous generation(s) or similar
        devices
   4.7 Risk assessment
   4.8 Control of infection and microbial contamination
   4.9 Biological evaluation
   4.10 Clinical evaluation
   4.11 Manufacturing process
   4.12 Quality control of the implant manufacturing process
   4.13 Packaging
        4.13.1 Primary container
        4.13.2 Protection from damage in storage and transport
   4.14 Label
   4.15 Instructions for use
Bibliography

BS EN ISO 10451

Committee
CH/106/8
DocumentType
Draft
Pages
16
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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 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 406:1987 Technical drawings Tolerancing of linear and angular dimensions
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 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
ISO 9001:2015 Quality management systems — Requirements
ISO 14801:2016 Dentistry Implants Dynamic loading test for endosseous dental implants
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
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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