GB 12264-1990
Replaced
YY/T 1845-2022
Active
Industry standards-Medicine
YY/T 1845-2022 General requirements of guides for orthopaedic surgery
YY/T 1845-2022 General requirements of guides for orthopaedic surgery
Basic Information
Standard Code:
YY/T 1845-2022
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:
2022-07-01
Implement Date:
2023-07-01
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:
12 pages
Scope
本文件规定了矫形外科用手术导板的通用要求,包括要求、设计、制造、灭菌、制造商提供的信息。
本文件适用于矫形外科用手术导板,该类导板主要由高分子材料及金属材料通过3D打印制造,其他加工方式制造的导板可参考本文件相关条款。
注: 本文件涉及的检验方法参见附录A。
Development Information
Drafting Units:
北京爱康宜诚医疗器材有限公司、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、云南省第一人民医院、北京大学第三医院
Drafting Persons:
董双鹏、张晨、安俊波、王彩梅、李新宇、刘英慧、孙嘉怿、陆声、罗浩天、田华、蔡宏
Referenced Standards
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
YY/T 0726-2020 Instrumentation for use in association with non-active surgical implants—Gerneral requirements
中华人民共和国药典
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
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test 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 0297-1997 Clinical investigation of medical devices
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY/T 0640-2008 Non-active surgical implants—General requirements
YY/T 0640-2016 Non-active surgical implants—General requirements
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
YY/T 0297-2026 General requirements for clinical investigation of medical devices
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