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

Standard No.

EN ISO 7405:2018

Release Date

2018

Published By

European Committee for Standardization (CEN)

Status

Withdraw 2019-05

Latest

EN ISO 7405:2018

Replace By

prEN ISO 7405 rev

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.

EN ISO 7405:2018 history

• 2018 EN ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
• 2013 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)
• 2008 EN ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
• 1997 EN ISO 7405:1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials ISO 7405: 1997