GB 11243-2000
Replaced
YY 0781-2025
Pending
Industry standards-Medicine
YY 0781-2025 Blood pressure transducers
YY 0781-2025 Blood pressure transducers
Basic Information
Standard Code:
YY 0781-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical electronic instruments and equipment
ICS Name:
Diagnostic equipment
Publish Date:
2025-09-15
Implement Date:
2028-10-01
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医用电子仪器分技术委员会(SAC/TC 10/SC 5)
Pages:
28 pages
Scope
本文件规定了设计用来测量血压的经留置导管或直接穿刺的传感器、电缆的安全和性能的要求。
注1:本文件同时也给用户自己决定传感器和血压监护设备之间的兼容性提供参考。
注2:本文件未规定针对传感器或监护设备的操作程序。因此,参阅适合的使用说明书对于正确安装、平衡和校准血压测量系统是完全必要的。
本文件适用于经导管或直接的血管穿刺来测量血压的压力传感器,包括电缆。
本文件不适用于被设计用于测量其他生理参数的传感器。
注3:附录A给出了本文件部分条款的解释说明。
Development Information
Replace the following standards
Referenced Standards
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY 9706.234-2021 Medical electrical equipment—Part 2-34:Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
ISO 80369-7:2021
Related Standards
GB 1588-2001
Replaced
GB 1588-2001 Clinical thermometer
YY 0109-2003
Replaced
YY 0109-2003 Medical ultrasonic nebulizer
YY 0455-2003
Replaced
YY 0455-2003 Medical electrical equipment—Part 2:Particular requirments for the safety of infant radiant warmers
YY/T 1036-2004
Active
YY/T 1036-2004 Impression tonometers
GB/T 19665-2005
Replaced