ISO 10451:2010
Dentistry — Contents of technical file for dental implant systems
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.
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Scope
Normative references
Terms and definitions
Requirements
General
Intended use
Design characteristics
Properties of the constituent materials
Properties of the final product
Reference to previous generation(s) or similar devices
Risk assessment
Control of infection and microbial contamination
Biological evaluation
Clinical evaluation
Manufacturing process
Quality control of the implant manufacturing process
Packaging
Primary container
Protection from damage in storage and transport
Label
Instructions for use
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Related Information
Similar Standards
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BS EN 1642:2011
Dentistry. Medical devices for dentistry. Dental implants
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BS EN ISO 10451:2010
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Scope
Normative references
Terms and definitions
Requirements
General
Intended use
Design characteristics
Properties of the constituent materials
Properties of the final product
Reference to previous generation(s) or similar devices
Risk assessment
Control of infection and microbial contamination
Biological evaluation
Clinical evaluation
Manufacturing process
Quality control of the implant manufacturing process
Packaging
Primary container
Protection from damage in storage and transport
Label
Instructions for use