DZ/T 0101.12-1994
Active
YY/T 1901-2023
Active
Industry standards-Medicine
YY/T 1901-2023 Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology
YY/T 1901-2023 Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology
Basic Information
Standard Code:
YY/T 1901-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
-
Publish Date:
2023-09-05
Implement Date:
2024-09-15
Publisher:
国家药品监督管理局
Technical Committee:
医用机器人标准化技术归口单位
Pages:
25 pages
Scope
本文件规定了采用机器人技术的骨科手术导航设备(以下简称“骨科手术导航设备”)的技术要求,描述了相应的试验方法。
本文件适用于骨科手术(如关节置换外科、脊柱外科、创伤骨科等)导航设备。
Development Information
Drafting Units:
中国食品药品检定研究院、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、北京积水潭医院、中国人民解放军总医院、辽宁省医疗器械检验检测院、北京天智航医疗科技股份有限公司、美敦力(上海)管理有限公司、骨圣元化机器人(深圳)有限公司、华科精准(北京)医疗科技有限公司
Drafting Persons:
孟祥峰、彭亮、张立海、王晶、洪伟、田伟、张龙达、王浩、张超、郝烨、韩晓光、金路凯、徐进、李露、延廷芳、刘文博、王晨希、李澍、李佳戈、李静莉
Referenced Standards
YY/T 1712-2021 Assisted surgical medical equipment and assisted surgical medical system employing robotictechnology
中华人民共和国药典
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
YY/T 0752-2009 Electric surgical equipment for osseous tissue
YY/T 0752-2016 Electrical surgical equipment for osseous tissue
YY/T 1601-2018 Ultrasonic surgical equipment for osseous tissue
YY/T 0149-1993 Test method for corrosion resistance of stainless steel medical instruments
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