GB 12264-1990
Replaced
YY/T 0492-2026
Pending
Industry standards-Medicine
YY/T 0492-2026 Implantable lead
YY/T 0492-2026 Implantable lead
Basic Information
Standard Code:
YY/T 0492-2026
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2026-03-09
Implement Date:
2027-03-01
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有源植入物分技术委员会
Pages:
20 pages
Scope
本文件规定了植入式心脏起搏电极导线、植入式神经刺激器电极导线和延伸导线、植入式心脏除颤电极导线的要求。
本文件适用于植入式心脏起搏电极导线、植入式神经刺激器电极导线和延伸导线、植入式心脏除颤电极导线。
注1:本文件对不同的电极导线、延伸导线与脉冲发生器所组成的起搏器系统、神经刺激器系统或除颤器系统的功能相容性或可靠性方面没有做要求。
注2:植入式心脏起搏电极导线的连接器特性由YY/T 0491(IS-1)和YY/T 0972(IS4)规定。植入式心脏除颤电极导线的连接器特性由YY/T 0946(DF-1)和YY/T 0972(DF4)规定。
注3:本文件中规定的试验是型式试验,是通过对样品进行的试验来评估器械,不预期用来作为出厂检验的项目。
Development Information
Drafting Units:
清华大学、上海市医疗器械检验研究院、北京品驰医疗设备股份有限公司、苏州无双医疗设备有限公司、美敦力(上海)管理有限公司、乐普医学电子仪器股份有限公司、景昱医疗科技(苏州)股份有限公司、杭州佳量医疗科技有限公司
Drafting Persons:
王伟明、李永华、姜长青、陈雅、许扶、平利川、葛冬冬、张博天、张合、李朋、金华、邓伟、朱为然、曹鹏、文雄伟
Replace the following standards
Referenced Standards
GB/T 601-2002 Chemical reagent Preparations of standard volumetric solutions
GB/T 601-2016 Chemical reagent—Preparations of reference titration solutions
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 16174.1-2024 Implants for surgery—Active implantable medical devices—Part 1:General requirements for safety,marking and for information to be provided by the manufacturer
GB 16174.2-2024 Implants for surgery—Active implantable medical devices—Part 2:Cardiac pacemakers
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process
YY/T 0491-2004 Cardiac pacemakers—Low-profile connectors(IS-1) for implantable pacemakers
YY/T 0946-2014 Cardiac defibrillators—Connector assembly DF-1 for implantable defibrillators—Dimensions and test requirements
YY/T 0972-2016 Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements
YY 0989.3-2023 Implants for surgery—Active implantable medical devices—Part 3:Implantable neurostimulators
YY 0989.6-2025 Implants for surgery—Active implantable medical devices—Part 6:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced