本指南适用于根据ISO 10993-1的要求对医疗器械进行生物评估。它不会增加或改变ISO 10993-1的要求。本指南不包括用作监管检查或认证评估活动基础的要求。本指南适用于所有类型医疗器械的所有生物学评估，包括主动、非主动、植入式和非植入式医疗器械。

This guidance is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This guidance does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and nonimplantable medical devices.