EN ISO 7405:2008

Name: EN ISO 7405:2008
Brand: CEN
SKU: EN ISO 7405:2008
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Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008) EN ISO 7405:2008

Publication date: Aug 20, 2010

General information

Current stage: 99.60 Withdrawal effective Nov 28, 2018

Originator: CEN

Owner: CEN/TC 55 Dentistry

Type: European Norm

ICS: 11.060.10 Dental materials | 11.100 Laboratory medicine

Buying

Status: Withdrawn

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

PREVIOUSLY

WITHDRAWN
EN ISO 7405:1997

NOW

WITHDRAWN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

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 7405:2008/A1:2013

REVISED BY

PUBLISHED
EN ISO 7405:2018