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SNV - SN EN 1642

Dentistry - Medical devices for dentistry - Dental implants

active, Most Current
Organization: SNV
Publication Date: 1 January 2012
Status: active
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:
ISO 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
This document references:
EEC/2007/47 - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Published by EEC on September 5, 2007
A description is not available for this item.
This document references:
93/42/EEC - Council Directive Concerning Medical Devices
Published by EU on June 14, 1993
Definitions, scope 1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
Published by ISO on October 1, 2018
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the...
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