YY 0018-2026 Pending Industry standards-Medicine

YY 0018-2026 Implants for osteosynthesis—Metallic bone screws

Publish Date: 2026-03-09 Implement Date: 2028-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0018-2026

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: 2026-03-09

Implement Date: 2028-03-01

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骨科植入物分技术委员会(SAC/TC 110/SC 1)

Pages: 28 pages

Scope

本文件规定了骨接合植入器械金属接骨螺钉（以下简称“接骨螺钉”）的要求、制造、灭菌、包装、制造商提供的信息，描述了相应的试验方法。
本文件适用于骨科手术中骨折内固定用的接骨螺钉。
本文件不适用于脊柱螺钉、颅颌面螺钉和可吸收金属接骨螺钉。
注：可吸收金属接骨螺钉也能参考本文件，附录A给出了相关信息。

Development Information

Word Count: 38 Thousand words Pages: 28 pages

Replace the following standards

YY 0018-2016 Implants for osteosynthesis—Metallic bone screws

Referenced Standards

GB 4234.1-2017 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel GB 4234.1-2026 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 14233.3-2024 Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological test methods GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals YY 0341.1-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 1:Particular requirements for osteosynthesis implants YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants YY/T 0640-2016 Non-active surgical implants—General requirements YY/T 0662-2008 Implants for surgery—Metal bone screws with asymmetrical thread and spherical under-surface—Mechanical requirements and test methods YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products YY/T 1504-2016 Implants for surgery—Test method for determining the axial pullout strength of metallic bone screws YY/T 1505-2016 Implant for surgery—Test method for determining the self-tapping performance of metallic bone screws YY/T 1506-2016 Implants for surgery—Test method for driving torque of metallic bone screws YY/T 1615-2018 Surgical implants—Anodizing oxide layers on titanium and titanium alloys—General requirements

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