GB 11243-2000
Replaced
YY/T 1719-2023
Active
Industry standards-Medicine
YY/T 1719-2023 General requirements of positron emission tomographs and magnetic resonance equipment
YY/T 1719-2023 General requirements of positron emission tomographs and magnetic resonance equipment
Basic Information
Standard Code:
YY/T 1719-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
Diagnostic equipment
Publish Date:
2023-01-13
Implement Date:
2026-01-15
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医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages:
16 pages
Scope
本文件规定了正电子发射断层成像及磁共振成像设备（包含正电子发射断层成像及磁共振成像系统，以下简称PET/MR)的术语和定义、要求与试验方法。
本文件适用于可顺序扫描或同步扫描的分体式PET/MR或一体式PET/MR。
Development Information
Drafting Units:
上海联影医疗科技股份有限公司、上海市医疗器械检验研究院、上海市医疗器械化妆品审评核查中心
Drafting Persons:
庞和喜、胡晟、刘歆、胡凌志、沈振华、杨煜、杨义强
Referenced Standards
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 18988.1-2013 Radionuclide imaging device—Characteristics and test conditions—Part 1:Positron emission tomograph
YY/T 1840-2023 General specifications for medical magnetic resonance equipment
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 17857-1999 Medical radiology—Terminology(Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
YY/T 0482-2004 Technical requirements and test methods for magnetic resonance equipment for medical diagnosis
YY/T 0482-2010 Magnetic resonance equipment for medical imaging—Part 1:Determination of essential image quality parameters
YY/T 0482-2022 Magnetic resonance equipment for medical imaging—Determination of essential image quality parameters
YY 9706.233-2021 Medical electrical equipment—Part 2-33:Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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