YY/T 0841-2023 Active Industry standards-Medicine

YY/T 0841-2023 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment

YY/T 0841-2023 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment

Publish Date: 2023-09-05 Implement Date: 2025-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0841-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Medical equipment
Publish Date: 2023-09-05
Implement Date: 2025-09-15
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: 52 pages

Scope

本文件规定了符合GB 9706.1的医用电气设备和医用电气系统(以下简称为ME设备和ME系统)以及它们的部件在交付前、保养中、检查中、修理后以及其他服务中的测试,或周期性测试的要求。
本文件未规定修理、部件互换和ME设备或ME系统更改的要求。
本文件适用于符合GB 9706.1的ME设备和ME系统以及它们的部件。
本文件不适用于评估ME设备、ME系统或其他某种设备的设计是否符合它们的相关标准。
本文件不适用于ME系统的组装。关于ME系统的组装,见GB 9706.1—2020第16章。
注: 在本文件中,未标明版本的GB 9706.1是指GB 9706.1—1995、GB 9706.1—2007或GB 9706.1—2020。

Development Information

Drafting Units:

上海市医疗器械检验研究院、深圳迈瑞生物医疗电子股份有限公司、上海西门子医疗器械有限公司

Drafting Persons:

卓越、陶华、鲍华、冯小芸、冯广州、周家杰

Word Count: 95 Thousand words Pages: 52 pages

Replace the following standards

Referenced Standards

GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.5-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for hand-held probe assemblies for electrical measurement and test GB 4793.5-2008 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 5:Safety requirements for hand-held probe assemblies for electrical measurement and test GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 17045-1997 Protection against electric shock—Common aspects for installation and equipment GB/T 17045-2006 Protection against electric shock—Common aspects for installation and equipment GB/T 17045-2008 Protection against electric shock—Common aspects for installation and equipment GB/T 17045-2020 Protection against electric shock—Common aspects for installations and equipment GB/T 18216.1-2000 Electrical safety in low voltage distribution systems up to 1000V a.c. and 1500V d.c.—equipment for testing, measuring or monitoring of protective measuring Part 1:General requirements GB/T 18216.1-2012 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing,measuring or monitoring of protective measures—Part 1:General requirements GB/T 18216.1-2021 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c.—Equipment for testing,measuring or monitoring of protective measures—Part 1:General requirements GB/T 18216.2-2002 Electrical safety in low voltage distribution systems up to 1000V a.c. and 1500V d.c.—Equipment for testing, measuring or monitoring of protective measuring—Part 2:Insulation resistance GB/T 18216.2-2012 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing, measuring or monitoring of protective measures—Part 2:Insulation resistance GB/T 18216.2-2021 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing,measuring or monitoring of protective measures—Part 2:Insulation resistance GB/T 18216.4-2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c—Equipment for testing, measuring or monitoring of protective measures—Part 4:Resistance of earth connection and equipotential bonding GB/T 18216.4-2012 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing, measuring or monitoring of protective measures—Part 4:Resistance of earth connection and equipotential bonding GB/T 18216.4-2021 Electrical safety in low voltage distribution systems up to 1 000 V a.c and 1 500 V d.c—Equipment for testing,measuring or monitoring of protective measures—Part 4:Resistance of earth connection and equipotential bonding

Adopt standards

IEC 62353:2014

Related Standards

Contact Us