Abstract

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.

Begin

2021-09-16

WI

00055516

Planned document number

DIN EN ISO 7405

Project number

01402341

Responsible national committee

NA 014-00-20 AA - Biological and clinical material testing  

Responsible european committee

CEN/TC 55 - Dentistry  

Responsible international committee

ISO/TC 106/WG 10 - Biological evaluation  

draft standard

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024); German and English version prEN ISO 7405:2024
2024-04
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previous edition(s)

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018
2019-03

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