GB 12264-1990
Replaced
YY/T 0965-2025
Pending
Industry standards-Medicine
YY/T 0965-2025 Implants for sports medicine—Particular requirements of artificial ligaments
YY/T 0965-2025 Implants for sports medicine—Particular requirements of artificial ligaments
Basic Information
Standard Code:
YY/T 0965-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2025-09-15
Implement Date:
2026-10-01
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(SAC/TC 110)
Pages:
28 pages
Scope
本文件规定了供临床使用的运动医学植入器械人工韧带的预期性能、设计属性、材料、设计评价、临床前评价、上市后跟踪、制造、灭菌和包装的要求，描述了相应的试验方法。
本文件适用于纺织型人工韧带，其他类型的人工韧带参考使用本文件。
Development Information
Drafting Units:
中国食品药品检定研究院、上海利格泰生物科技股份有限公司、河北省药品医疗器械检验研究院、复旦大学附属华山医院、上海交通大学医学院附属第六人民医院、东华大学、华南理工大学、拉思医疗技术(上海)有限公司、天津市医疗器械质量监督检验中心、北京运康恒业生物技术有限公司
Drafting Persons:
付步芳、李崇崇、王远强、邵文亮、陈世益、赵金忠、王璐、杜昶、肖翔、张述、黄元礼、刘丽、郭雯欣、郭采妮、陈丹丹、刘若锦、陈俊、位晓娟、林婧、郝丽静、刘清油、张皓成、仇万裕
Replace the following standards
Referenced Standards
GB/T 3923.1-2013 Textiles—Tensile properties of fabrics—Part 1:Determination of maximum force and elongation at maximum force using the strip method
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
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
YY/T 0640-2016 Non-active surgical implants—General requirements
中华人民共和国药典 2020年版 四部
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