ISO 7405:2025
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 60
- Дата публикации:
- 20 июня 2025 г.
- Издание:
- ISO IS 7405 edition 4 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 7405:2025 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry is the ISO international standard that specifies test methods and evaluation processes for assessing the of dental medical devices. The fourth edition (2025) replaces and consolidates guidance on sample preparation, test selection, categorization by contact type and duration, and specific in vitro and in vivo tests. The standard covers devices and pharmacological agents that come into direct or indirect contact with the patient; it does apply to materials/devices that never contact the patient.
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