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EN ISO 7405:2008/A1:2013

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013) EN ISO 7405:2008/A1:2013

Publication date:   Aug 15, 2013

General information

99.60 Withdrawal effective   Nov 28, 2018

CEN

CEN/TC 55 Dentistry

European Norm

11.060.10   Dental materials | 11.100.99   Other standards related to laboratory medicine

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Scope

ISO 7405:2008 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. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 7405:2008

NOW

WITHDRAWN
EN ISO 7405:2008/A1:2013
99.60 Withdrawal effective
Nov 28, 2018

REVISED BY

PUBLISHED
EN ISO 7405:2018