GB 12259-1990
Abolished
YY/T 1853-2022
Active
Industry standards-Medicine
YY/T 1853-2022 Cutting tools for osseous tissue ultrasonic surgical equipment
YY/T 1853-2022 Cutting tools for osseous tissue ultrasonic surgical equipment
Basic Information
Standard Code:
YY/T 1853-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical ultrasound, laser, and high-frequency instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2022-08-17
Implement Date:
2024-09-01
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超声设备分技术委员会(SAC/TC 10/SC 2)
Pages:
6 pages
Scope
本文件规定了超声骨组织手术设备刀具(以下简称刀具)的术语和定义、要求和试验方法。
本文件适用于超声骨组织手术设备刀具。
本文件不适用于超声软组织切割止血手术设备刀具。
Development Information
Drafting Units:
湖北省医疗器械质量监督检验研究院、北京水木天蓬医疗技术有限公司
Drafting Persons:
蒋时霖、曹群、王志俭、吴成志、战松涛
Referenced Standards
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
YY/T 1601-2018 Ultrasonic surgical equipment for osseous tissue
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
Related Standards
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Abolished
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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