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YY 0118-2016

Chinese standards (related to): 'YY 0118-2016'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
YY 0118-2016English145 Add to Cart 0--10 minutes. Auto immediate delivery. Joint replacement implants - Hip joint prostheses YY 0118-2016 Valid YY 0118-2016
YY 0118-2005English105 Add to Cart 0--10 minutes. Auto immediate delivery. Hip joint prostheses YY 0118-2005 Obsolete YY 0118-2005
YY 0118-1993English639 Add to Cart Days<=5 (Hip prosthesis) YY 0118-1993 Obsolete YY 0118-1993


   
BASIC DATA
Standard ID YY 0118-2016 (YY0118-2016)
Description (Translated English) Joint replacement implants. Hip joint prostheses
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 15,199
Date of Issue 1/26/2016
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0118-2005
Quoted Standard GB/T 10610; GB/T 14233.1; GB/T 14233.2; GB/T 16886.7; GB 18278; GB 18279; GB 18280; GB/T 19701.1; GB/T 19701.2; GB 23101.2; YY 0117.1; YY 0177.2; YY 0177.3; YY/T 0343; YY/T 0772.3; YY/T 0772.4; YY/T 0772.5; YY/T 0809.1; YY/T 0809.2; YY/T 0811; YY/T 0920; ISO 4287; ISO 6474-1
Drafting Organization (Beijing) Co., Ltd., the State Food and Drug Administration Medical Device Technology Review Center (Beijing) Co., Ltd., Beijing Medical Device Quality Supervision and Inspection Center, Beijing 100 Screen Aviation Materials High-tech Co., Ltd., Shi Lehui Surgical Implants
Administrative Organization National Technical Committee on Orthopedic Implants for Orthopedic Implants and Orthopedic Devices Technical Committee (SAC/TC 110/SC 1)
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the terms and definitions of partial and total hip prostheses, the requirements for classification and dimensioning, expected performance, design properties, materials, design evaluation, manufacture, sterilization, packaging and information provided by the manufacturer. This standard applies to partial and total hip prostheses made using the materials and processes specified in this standard.