YY 0341.2-2020 Active Industry standards-Medicine

YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants

YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants

Publish Date: 2020-09-27 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: YY 0341.2-2020
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: 2020-09-27
Implement Date: 2022-06-01
Pages: 16 pages

Scope

This part of YY 0341 specifies the special requirements for passive surgical spinal implants (hereinafter referred to as "spinal implants"). In addition to the requirements specified in YY/T 0640, it also stipulates the definition, requirements, test methods, manufacturing, sterilization, packaging, and information provided by the manufacturer of spinal implants.
This part of YY 0341 applies to passive surgical spinal implants other than artificial disc implants.

Development Information

Word Count: 22 Thousand words Pages: 16 pages

Same series standard

Replace the following standards

YY 0341-2009

Referenced Standards

YY/T 0640-2016 Non-active surgical implants—General requirements 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 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological 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 GB 23101.2-2008 Implants for surgery—Hydroxyapatite—Part 2:Coatings of hydroxyapatite YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products YY/T 1428-2016 Spinal implants—Relevant terms YY/T 1615-2018 Surgical implants—Anodizing oxide layers on titanium and titanium alloys—General requirements YY/T 1706.1-2020 Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic surgical implants—Part 1:General requirements GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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