YY 0018-2026 Pending Industry standards-Medicine

YY 0018-2026 Implants for osteosynthesis—Metallic bone screws

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

Price: $ 74

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

Pages: 28 pages

Scope

This document specifies the requirements, manufacturing, sterilization, packaging, and information provided by manufacturers for metal bone implant screws (hereinafter referred to as "bone screws"), and describes the corresponding test methods.
This document applies to bone screws used for internal fixation of fractures in orthopedic surgery.
This document does not apply to spinal screws, craniomaxillofacial screws, and resorbable metal bone screws.
Note: Resorbable metal bone screws can also refer to this document, and Appendix A provides relevant information.

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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