YY 0018-2016 Active Industry standards-Medicine

YY 0018-2016 Implants for osteosynthesis—Metallic bone screws

YY 0018-2016 Implants for osteosynthesis—Metallic bone screws

Publish Date: 2016-07-29 Implement Date: 2018-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0018-2016
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: 2016-07-29
Implement Date: 2018-06-01
Pages: 22 pages

Scope

This standard specifies the terms and definitions, classification, requirements, test methods, manufacturing, sterilization, packaging, and information provided by manufacturers for bone implants - metal bone screws.
This standard applies to metal bone screws (hereinafter referred to as "bone screws"), which are used for internal fixation of fractures in orthopedic surgery. However, this standard does not include spinal and specially designed bone screws.

Development Information

Word Count: 42 Thousand words Pages: 22 pages

Replace the following standards

Referenced Standards

ISO 5835 ISO 9268 GB 4234-1994 Stainless steel for surgical implants GB 4234-2003 Stainless steel for surgical implants GB 4234.1-2017 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel GB 4234.4-2019 Implants for surgery—Metallic materials—Part 4:Cobalt-chromium-molybdenum casting alloy GB 4234.9-2023 Implants for surgery—Metallic materials—Part 9:Wrought high nitrogen 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 13810-1997 Wrought titanium and titanium alloy for surgical implants GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants GB/T 13810-2017 Wrought titanium and titanium alloy for surgical implants GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB 23102-2008 Implants for surgery—Metallic materials—Wrought titanium-6aluminium-7niobium alloy YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products YY 0341-2002 General technological requirements for non-active metallic surgery implants of osteosynthesis YY 0341.1-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 1:Particular requirements for osteosynthesis implants YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants YY 0605.9-2007 Implants for surgery—Metallic materials—Part 9:Wrought high nitrogen stainless steel YY 0605.9-2015 Implants for surgery—Metallic materials—Part 9:Wrought high nitrogen stainless steel YY/T 0640-2008 Non-active surgical implants—General requirements 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 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 GB 4234.3-2024 Implants for surgery—Metallic materials—Part 3:Wrought titanium 6-aluminum 4-vanadium alloy GB 4234.2-2024 Implants for surgery—Metallic materials—Part 2:Unalloyed titanium GB 4234.7-2024 Implants for surgery—Metallic materials—Part 7:Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy GB 4234.12-2024 Implants for surgery—Metallic materials—Part 12:Wrought cobalt-chromium-molybdenum alloy GB 4234.11-2025 Implants for surgery—Metallic materials—Part 11:Wrought titanium 6-aluminium 7-niobium alloy GB 4234.1-2026 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel

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