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近年来,FDA加强了对医疗仪器和卫生保健装置中使用的软件的管理。随着技术的飞速发展,这种管理对工业、医疗仪器经营者以及标准化组织提出了新的挑战。工业生产必须按照不断更改的法规进行,管理人员必须对仪器的鉴定、购置负责并监护软件的安全、有效和可靠性。在这种情况下标准化组织不得不提出在设计和使用上应遵循的准
In recent years, the FDA has strengthened the management of software used in medical instruments and health care devices. With the rapid development of technology, this kind of management poses new challenges to industry, medical equipment operators and standardization organizations. Industrial production must be carried out in accordance with continuously changing regulations. Managers must be responsible for the identification and purchase of the instrument and monitor the safety, effectiveness, and reliability of the software. In this case, the standardization organization has to propose standards that should be followed in design and use.