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

Publish Date: 2022-07-01 Implement Date: 2023-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 20 Thousand words Pages: 12 pages

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

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