ISO 7405:2018 牙科 牙科用医疗器械的生物相容性评估

标准编号：ISO 7405:2018

中文名称：牙科 牙科用医疗器械的生物相容性评估

英文名称：Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

发布日期：2018-10

标准范围

本文件规定了牙科医疗器械生物效应评估的试验方法。它包括药理学试剂的测试，这些试剂是受试设备的组成部分。本文件不包括与患者身体不直接或间接接触的材料和设备的测试。

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.

标准预览图