GB/T 16886.11-1997
Replaced
YY/T 1928-2023
Active
Industry standards-Medicine
YY/T 1928-2023 Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment
YY/T 1928-2023 Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment
Basic Information
Standard Code:
YY/T 1928-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2023-11-22
Implement Date:
2024-12-01
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:
32 pages
Scope
本文件界定了预期用于磁共振环境的医用电气设备的术语，规定了预期用于磁共振环境的医用电气设备的分类。
本文件适用于在磁共振环境中使用的医用电气设备。
Development Information
Drafting Units:
国家药品监督管理局医疗器械技术审评中心、上海市医疗器械检验研究院、复旦大学、北京市医疗器械审评检查中心、深圳迈瑞生物医疗电子股份有限公司、兰州大学
Drafting Persons:
王晶、洪伟、杨鹏飞、邬小玫、陈然、李永华、陶华、姚爱萍
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