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YY 0502-2016   Joint replacement implants―Knee joint prostheses (English Version)
Standard No.: YY 0502-2016 Status:valid remind me the status change
Language:English File Format:PDF
Word Count: 10500 words Price(USD):180.0 remind me the price change
Implemented on:2018-1-1 Delivery: via email in 1 business day
Standard No.: YY 0502-2016
English Name: Joint replacement implants―Knee joint prostheses
Chinese Name: 关节置换植入物膝关节假体
Chinese Classification: C35    Orthopedic devices
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by: China Food and Drug Adminstration
Issued on: 2016-01-26
Implemented on: 2018-1-1
Status: valid
Superseding:YY 0502-2005 Knee joint prostheses
Language: English
File Format: PDF
Word Count: 10500 words
Price(USD): 180.0
Delivery: via email in 1 business day
Referred in YY 0502-2016:
*GB/T 10610-2009 Geometrical product specifications(GPS) - Surface texture:Profile method - Rules and procedures for the assessment of surface texture
*GB/T 14233.1-2008 Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods
*GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
*GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
*GB 18278-2000 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
*GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization
*GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
*GB/T 19701.1-2016 Implants for surgery-Ultra-high-molecular-weight polyethylene- Part 1:Powder form
*GB/T 19701.2-2016 Implants for surgery-Ultra-high-molecular-weight polyethylene- Part 2:Moulded forms
*GB 23101.2-2008 Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite
*YY 0117.1-2005 Implants for surgery - Forgings, castings for bone joint prostheses - Ti6Al4V titanium alloy forgings
*YY 0117.2-2005 Implants for surgery-Forgings, castings for bone joint prostheses-ZTi6Al4V titanium alloy castings
*YY 0117.3-2005 Implants for surgery-Forgings, castings for bone joint prostheses Cobalt chromium molybdenum alloy castings
*YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants
*YY/T 0772.3-2009 Implants for surgery Ultra-high-molecular-weight polyethylene Part 3:Accelerated ageing methods
*YY/T 0772.4-2009 Implants for surgery-ultra-high-molecular-weight polyethylene Part 4:Oxidation index measurement method
*YY/T 0772.5-2009 Implants for surgery Ultra-high-molecular-weight polyethylene Part 5:Morphology assessment method
*YY/T 0810.1-2010 Implants for surgery—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays
*YY/T 0811-2010 Standard guide for extensively irradiation—Crosslinked ultrahigh molecular weight polyethylene fabricated forms for surgical implant applications
*YY/T 0919-2014 Non-active surgical implants―Joint replacement implants―Specific requirements for knee-joint replacement implants
*YY/T 0924.1-2014 Implants for surgery―Components for partial and total knee joint prostheses―Part 1:Classification, definitions and designation of dimensions
*YY/T 0924.2-2014 Implants for surgery―Components for partial and total knee joint prostheses―Part 2:Articulating surfaces made of metal,ceramic and plastics materials
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