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EN ISO 7405:2018

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12) EN ISO 7405:2018

Publication date:   Feb 14, 2019

General information

60.60 Standard published   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

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 device under test.
This document 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WITHDRAWN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

WITHDRAWN
EN ISO 7405:2008/A1:2013

NOW

PUBLISHED
EN ISO 7405:2018
60.60 Standard published
Nov 28, 2018

REVISED BY

IN_DEVELOPMENT
prEN ISO 7405