YY/T 1925-2024 Active Industry standards-Medicine

YY/T 1925-2024 Cardiovascular implants endovascular devices—Neurovascular stent retriever

YY/T 1925-2024 Cardiovascular implants endovascular devices—Neurovascular stent retriever

Publish Date: 2024-02-07 Implement Date: 2025-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1925-2024
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2024-02-07
Implement Date: 2025-03-01
Publisher: 国家药品监督管理局
Technical Committee: 全国外科植入物和矫形器械标准化技术委员会心血管植入物分技术委员会(SAC/TC 110/SC 2)
Pages: 28 pages

Scope

本文件规定了神经血管取栓支架(简称“取栓支架”)的通用要求、预期性能、设计属性、材料、实验室设计评估、上市后监督、制造、灭菌、包装的要求。本文件适用于预期用于移除缺血性脑卒中患者神经血管中的血栓,从而恢复血管血流畅通的取栓支架。本文件不适用于取栓术中其他可能用到的器械和/或辅件,如球囊导管、微导丝、微导管等。注: YY/T 1747规定了颅内动脉支架性能的通用要求,如果制造商预期取栓支架可能在颅内解脱,作为植入物留在患者体内,则参考颅内动脉支架的相关要求。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、国家药品监督管理局医疗器械技术审评中心、国家药品监督管理局医疗器械技术审评检查大湾区分中心、艾柯医疗器械(北京)股份有限公司、江苏暖阳医疗器械有限公司

Drafting Persons:

张争辉、马金竹、焦永哲、乔嘉琪、朱丽丽、程茂波、穆兰兰、连小奇、陈易北、吕怡然、高洪亮、孙冰

Word Count: 48 Thousand words Pages: 28 pages

Referenced Standards

YY 0450.1-2020 Accessory devices for sterile single-use intravascular catheters—Part 1:Introducers 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 GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices GB/T 42062-2022 Medical devices—Application of risk management to medical devices YY/T 0640-2008 Non-active surgical implants—General requirements YY/T 0640-2016 Non-active surgical implants—General requirements GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices

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