ISO 7405:2018
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 43
- Дата публикации:
- 15 октября 2018 г.
- Издание:
- ISO IS 7405 edition 3 version 1
- ICS:
- 11.060.10
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.
Abstract
Overview
ISO 7405:2018 - Dentistry: Evaluation of biocompatibility of medical devices used in dentistry specifies test methods and a biological evaluation framework for dental medical devices that come into direct or indirect contact with patients. It covers device categorization, material characterization as a first step, selection of biological tests, and specific dental test methods (including tests for integrated pharmacological agents). Devices that do not contact the patient are excluded.
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