YY 0017-2016 Active Industry standards-Medicine

YY 0017-2016 Implants for osteosynthesis—Metallic bone plates

YY 0017-2016 Implants for osteosynthesis—Metallic bone plates

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 0017-2016

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: 18 pages

Scope

This standard specifies the relevant terms and definitions, requirements, test methods, manufacturing, sterilization, packaging, and information provided by manufacturers for bone implants - metal bone plates (hereinafter referred to as "bone plates").
This standard applies to bone plates used for connecting fractured bone ends during orthopaedic surgery. This standard is not applicable to all types of bone plates. Users should evaluate the applicability of this standard based on the specific type and intended use of the bone plates and specify the performance requirements of the corresponding products.
This standard is not applicable to craniomaxillofacial bone plates, angle fixators, spinal fixation plates, etc., and does not include descriptions and requirements for specially designed bone plates.

Development Information

Word Count: 34 Thousand words Pages: 18 pages

Replace the following standards

YY 0017-2008 Implants for osteosynthesis—Metallic bone plates

Referenced Standards

ISO 5836 ISO 9269 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 0018-2002 Implants for osteosynthesis—Metallic bone screws YY 0018-2008 Implants for osteosynthesis—Metallic bone screws YY 0018-2016 Implants for osteosynthesis—Metallic bone screws YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products YY/T 0342-2002 Implants for surgery—Determination of bending strength and stiffness of bone plates YY/T 0342-2020 Implants for surgery—Determination of bending strength and stiffness of bone plates 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 1503-2016 Implants for surgery—Test method for determining the bending fatigue properties of metallic bone plates 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 YY 0018-2026 Implants for osteosynthesis—Metallic bone screws GB 4234.1-2026 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel

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