ISO 16142的这一部分包括安全和性能的基本原则，确定了可用于评估医疗器械是否符合公认基本原则的重要标准和指南，这些基本原则一旦满足，就表明医疗器械是安全的，并按预期运行。本标准确定并描述了适用于所有医疗设备（包括IVD医疗设备（体外诊断））的六项安全和性能基本原则。

This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This standard identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).