GB 12264-1990
Replaced
YY/T 1823-2022
Active
Industry standards-Medicine
YY/T 1823-2022 Cardiovascular implants—Standard test method for nickel ion release of nickel-titanium alloy
YY/T 1823-2022 Cardiovascular implants—Standard test method for nickel ion release of nickel-titanium alloy
Basic Information
Standard Code:
YY/T 1823-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2022-05-18
Implement Date:
2023-06-01
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:
20 pages
Scope
本文件规定了镍钛合金心血管植入物镍离子体外释放的试验方法，给出了植入物体外镍离子释放最大允许限量的推算示例。
本文件适用于镍钛合金心血管植入物，包括血管支架、心脏封堵器、腔静脉滤器、心脏瓣膜等。
Development Information
Drafting Units:
先健科技(深圳)有限公司、深圳市领先医疗服务有限公司、深圳市医疗器械检测中心、江阴法尔胜佩尔新材料科技有限公司、国标(北京)检验认证有限公司、天津市医疗器械质量监督检验中心
Drafting Persons:
刘艳文、穆盈、李安宁、杨涵、彭俊、王玲玲、陈庆福、张文梅、樊志罡、马金竹、段青姣
Referenced Standards
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances
中国药典 (2020年版 四部)
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
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