GB 12259-1990
Abolished
YY/T 0324-2019
Active
Industry standards-Medicine
YY/T 0324-2019 Infrared screening equipment for mammary gland
YY/T 0324-2019 Infrared screening equipment for mammary gland
Basic Information
Standard Code:
YY/T 0324-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Physiotherapy and traditional Chinese medicine instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2019-05-31
Implement Date:
2020-06-01
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物理治疗设备分技术委员会(SAC/TC 10/SC 4)
Pages:
8 pages
Scope
本标准规定了红外乳腺检查仪的术语和定义、组成及分类、要求和试验方法。
本标准适用于通过红外光探头对乳腺组织进行照射透视，经摄像系统把摄取的图像显示在屏幕上，对乳腺疾病进行检查的仪器（以下简称检查仪）。
Development Information
Drafting Units:
天津市医疗器械质量监督检验中心、北京市医疗器械技术审评中心
Drafting Persons:
陈成、王颖、杨建刚
Replace the following standards
Referenced Standards
GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.15-2008 Medical electrical equipment—Part1:General requirements for safety—1.Collateral standard:Safety requirements for medical electrical systems
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 20145-2006 Photobiological safety of lamps and lamp systems
YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
Related Standards
GB 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced