GB 9706.8-1995
Replaced
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
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
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
GB 11235-1997
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GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced