ISO 14155:2011涵盖了在人类受试者进行的临床调查的设计，执行，记录和报告方面的良好临床实践，以评估用于监管目的的医疗设备的安全性或性能。 ISO 14155:2011中规定的原则也适用于所有其他临床调查，并应尽可能遵循临床调查的性质和国家规定的要求。 ISO 14155:2011规定了旨在保护人类受试者的权利，安全和福祉的一般要求，确保科学进行临床调查和结果的可信度，确定担保人和主要调查员的责任，并协助赞助人，调查人员，伦理委员会，监管机构等参与医疗器械合格评定的机构。 ISO 14155:2011不适用于体外诊断医疗器械

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations. ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. ISO 14155:2011 does not apply to in vitro diagnostic medical devices.