YY/T 9706.106-2021 Active Industry standards-Medicine

YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability

YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability

Publish Date: 2021-03-09 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 9706.106-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Medical equipment
Publish Date: 2021-03-09
Implement Date: 2023-05-01
Publisher: 国家药品监督管理局
Technical Committee: 全国医用电器标准化技术委员会(SAC/TC 10)
Pages: 15 pages

Scope

本部分规定了制造商用于分析、定义、设计、验证和确认与医用电气设备(以下简称ME设备)基本安全和基本性能相关的可用性的过程。
可用性工程过程评估并降低了正常使用时由于正确使用或使用错误等可用性问题所引起的风险。其可用于鉴别与非正常使用相关的风险,但不用于评估或降低这类风险。
除非有客观证据显示不可接受(见YY/T 1474 —2016的4.1.2),如果可用性工程过程符合本部分的要求且可用性确认计划中规定的接受准则得到满足(见YY/T 1474-2016的5.9),则可以认为ME设备中与可用性相关的在YY/T 0316中定义的剩余风险是可接受的。
注: 星号(*)作为标题的第一个字符或段落或表格标题的开头,表示在附录A中有与之相关的指南或原理说明。

Development Information

Drafting Units:

上海市医疗器械检测所、深圳迈瑞生物医疗电子股份有限公司

Drafting Persons:

何骏、邵凌云、胡晟

Word Count: 28 Thousand words Pages: 15 pages

Same series standard

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Referenced Standards

Adopt standards

IEC 60601-1-6:2013

Related Standards

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