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SNV - SN EN 1642

Dentistry - Medical devices for dentistry - Dental implants

inactive
Organization: SNV
Publication Date: 1 March 2010
Status: inactive
Page Count: 13
ICS Code (Dental implants): 11.060.15
scope:

This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.

This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

Document History

SN EN 1642
January 1, 2012
Dentistry - Medical devices for dentistry - Dental implants
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and...
SN EN 1642
March 1, 2010
Dentistry - Medical devices for dentistry - Dental implants
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and...
SN EN 1642
August 1, 2004
Dentistry - Medical devices for dentistry - Dental implants
A description is not available for this item.

References

This document references:
EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Published by CEN on January 1, 2020
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of...
This document references:
ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Published by ISO on February 1, 2019
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
This document references:
EN ISO 14155-2 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
Published by CEN on July 1, 2009
A description is not available for this item.
This document references:
EN 1041 - Information supplied by the manufacturer of medical devices
Published by CEN on August 1, 2008
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
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