GB/T 16886.11-1997
Replaced
YY/T 1830-2022
Active
Industry standards-Medicine
YY/T 1830-2022 Electrical pneumatic touriquet equipment
YY/T 1830-2022 Electrical pneumatic touriquet equipment
Basic Information
Standard Code:
YY/T 1830-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2022-05-18
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医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages:
20 pages
Scope
本文件规定了电动气压止血仪的要求和试验方法。
本文件适用于四肢手术中，电动气压压迫阻断止血类设备。
本文件不适用于专用于股动脉止血的止血类设备，也不适用于无源手动充气止血设备，上述产品可参考本文件的适用内容。
Development Information
Drafting Units:
上海市医疗器械检测所、浙江省医疗器械审评中心、杭州正大医疗器械有限公司、上海昌宁医疗科技有限公司
Drafting Persons:
赵扬、朱文武、严红成、胡凯、郑飞翔
Referenced Standards
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 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
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 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced