YY/T 0685-2025 Pending Industry standards-Medicine

YY/T 0685-2025 Neurosurgical implants—Self-closing intracranial aneurysm clips

Publish Date: 2025-09-15 Implement Date: 2026-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0685-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

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: 16 pages

Scope

本文件规定了用于永久植入颅内的自闭合动脉瘤夹的特性及其设计要求、供应条件和灭菌、包装、由制造商提供的信息。其中，本文件设计要求中描述了闭合力的测试方法。
本文件不适用于可塑性夹，或外科手术过程中使用且伤口闭合前移除的临时性夹。注：本文件中，如果没有其他规定，术语“植入物”是指自闭合颅内动脉瘤夹。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、贝朗医疗(上海)国际贸易有限公司、大博医疗科技股份有限公司、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)

Drafting Persons:

段青姣、朱丽丽、张争辉、尹子恒、孙惠丽、孙芸、姜洪霞、曾达、梁雄伟、孙璐、郝凤阳

Word Count: 16 Thousand words Pages: 16 pages

Replace the following standards

YY/T 0685-2008 Neurosurgical implants—Self-closing intracranial aneurysm clips

Referenced Standards

GB 4234.2-2024 Implants for surgery—Metallic materials—Part 2:Unalloyed titanium GB 4234.3-2024 Implants for surgery—Metallic materials—Part 3:Wrought titanium 6-aluminum 4-vanadium alloy GB 4234.7-2024 Implants for surgery—Metallic materials—Part 7:Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy 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 0605.5-2007 Implants for surgery—Metallic materials—Part 5:Wrought cobalt-chromium-tungsten-nickel alloy YY/T 0605.6-2007 Implants for surgery—Metallic materials—Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy YY/T 0640-2016 Non-active surgical implants—General requirements ISO 17664-1

Adopt standards

ISO 9713:2022

Related Standards

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