How do we define the "general purpose"?

作者：Tan Jin; Duan Xiaolian; Zhong Daidi^*; Kirwan Michael J

来源：Computer Standards & Interfaces, 2014, 36(6): 963-965.

DOI：10.1016/j.csi.2014.02.003

• Medical device regulation
• Device interoperability
• Personal health device
• Protocol stack

The intended purpose of a device is a key reference when regulators decide whether or not to regulate it as a medical device. However, when coming into consumer health domain, it is sometimes difficult to decide whether a device (or system) has a general purpose or not. The authors discussed the regulatory policy around health device connectivity, operating system and software market, and proposed to regulate them with enough granularity.

• 出版日期2014-11
• 单位重庆大学