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EVS-EN ISO 7405:2009

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

General information
Withdrawn from 19.12.2018
Base Documents
ISO 7405:2008; EN ISO 7405:2008
Directives or regulations
None
Standard history
Status
Date
Type
Name
19.12.2018
Main
09.09.2013
Amendment
05.02.2009
Main
Main
EVS-EN ISO 7405:1999
This International Standard 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 device under test. This International Standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
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Amendment

EVS-EN ISO 7405:2009/A1:2013

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)
Withdrawn from 19.12.2018
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EVS-EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Withdrawn from 02.01.2020
Main

EVS-EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Newest version Valid from 03.02.2011
Main

EVS-EN 1641:2009

Dentistry - Medical devices for dentistry - Materials
Newest version Valid from 06.01.2010