标准摘要
[中文适用范围]： 本文件规定了评估医疗器械材料引起全身不良反应的可能性时应遵循的要求并提供了指导。 [外文原描述]： ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
英文名称Biological evaluation of medical devices — Part 11: Tests for systemic toxicity