Riordan J J
Med Instrum. 1975 Jul-Aug;9(4):197-201.
Current practices for preparing standards in general--and standards for medical devices, instruments, and products in particular--are too slow, too expensive, and too cumbersome. There is a need, therefore, for establishing administrative mechanisms to expedite standards preparation. This paper addresses some administrative, conceptual, and methodological aspects of standards preparation and suggests actions that might contribute to improvements in the effectiveness of standards and in the methods of their preparation.
一般而言,当前制定标准的做法——尤其是医疗设备、器械和产品的标准——过于缓慢、成本过高且过于繁琐。因此,有必要建立行政机制来加快标准制定。本文探讨了标准制定在行政、概念和方法等方面的问题,并提出了一些可能有助于提高标准有效性及其制定方法的行动建议。