YY/T 1867-2023 Active Industry standards-Medicine

YY/T 1867-2023 Implants for sports medicine—Suture anchor

YY/T 1867-2023 Implants for sports medicine—Suture anchor

Publish Date: 2023-01-13 Implement Date: 2024-01-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1867-2023
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: 2023-01-13
Implement Date: 2024-01-15
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: 16 pages

Scope

本文件规定了运动医学植入器械带线锚钉(以下简称“带线锚钉”)的性能要求,给出了相应的试验方法,规定了制造、灭菌、生物学安全性评价、包装和制造商提供的信息等方面的内容。注: 附录A给出了本文件的基本原理。本文件适用于供运动医学手术中软组织和骨连接固定用的带线锚钉的测试评价。本文件也适用于非预置缝线的锚钉和全缝线锚钉的测试评价。

Development Information

Drafting Units:

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、北京市医疗器械审评检查中心、史赛克(北京)医疗器械有限公司、强生(上海)医疗器材有限公司、北京纳通科技集团有限公司、北京德益达美医疗科技有限公司、北京市富乐科技开发有限公司

Drafting Persons:

李文娇、董双鹏、张述、马春宝、袁博、郭晓磊、甄珍、郭旭、高春宇、陈睿恺、赵文文、孔庆俊、李洪艳

Word Count: 24 Thousand words Pages: 16 pages

Referenced Standards

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