我国医疗器械行业标准分类问题浅析

目的为医疗器械行业标准体系建设提供参考意见。方法介绍国家标准分类情况,对医疗器械行业标准体系建设中出现的标准分类问题进行举例分析。结果与结论应明确医疗器械行业标准类别的定义,制定标准命名原则和类别判定依据,以保证医疗器械行业标准体系建设以及数据库数据的准确性和统一性。

Brief Introduction and Discussion on the Sector Standards Classification of Medical Devices

Objective To provide comments and suggestions for building up standard system of medical devices. on some and Cone Methods It was introduced to the classification of national standards. questions arising from classification of standards in sector standards The analysis was carried out of medical devic lusion It should be clearly defined the term of classification of the sector standards. es. Results Developing nomenclature principles and classification justification of the standard, is to ensure the accuracy and unity of data for building up standard system of medical device.