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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Withdrawn from 19.12.2018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
ICS Groups
11.060.10 Dental materials 11.100 Laboratory medicine
Directives or regulations
None

Standard history

Status
Date
Type
Name
19.12.2018
Main
EVS-EN ISO 7405:2018
09.09.2013
Amendment
EVS-EN ISO 7405:2009/A1:2013
05.02.2009
Main
EVS-EN ISO 7405:2009
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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Standard monitoring
English (PDF 243 KB)

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Main

EVS-EN ISO 7405:2018

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Newest version Valid from 19.12.2018
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Withdrawn from 19.12.2018
Main

EVS-EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices
Newest version Valid from 01.09.2002
Main

EVS-EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
Newest version Valid from 01.05.2003

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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Withdrawn from 19.12.2018
Main

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Withdrawn from 02.01.2020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)
Withdrawn from 31.12.2020
Main

EVS-EN 1641:2009

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

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English