首页|医用电气设备新版GB9706系列标准实施难点及对医疗器械行业的影响

医用电气设备新版GB9706系列标准实施难点及对医疗器械行业的影响

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新版GB9706系列标准作为医用电气设备的基础标准,其发布与实施对我国医用电气设备行业具有重要的影响.文章主要综述GB9706系列标准历史发展脉络,新版标准实施的难点和创新点以及对生产企业、检验机构、审评监管部门带来的机遇和挑战.
Overview of the New GB9706 Series of Standards
The new GB9706 series of standards as a basic standard for medical electrical equipment,the release and implementation of the series of standards for China's medical electrical equipment industry has an important impact.This paper is an overview of the historical development of the GB9706 series of standards,the implementation of the new version of the standard difficulties and innovations,as well as on the production enterprises,inspection organisations,the review of the regulatory authorities to bring the opportunity and challenge.

the new version of GB9706 series of standardsmedical electrical equipmentoverview of standards

马凤莲、于文欣、王丽、黄忠亮

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广西壮族自治区医疗器械检测中心(广西 南宁 530031)

广西-东盟食品检验检测中心(广西 南宁 530021)

新版GB9706系列标准 医用电气设备 标准综述

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(19)