YY/T 0119.4-2014: Spinal implants - Components used in the surgical fixation of the spinal skeletal system - Part 4: Metallic spinal rods

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Scope

This Part of YY/T 0119 specifies classification, material and performance
requirements for metallic spinal rods.
This Part is applicable to the longitudinal elements in spinal fixation implants.

Basic Data

Standard ID	YY/T 0119.4-2014 (YY/T0119.4-2014)
Description (Translated English)	Spinal implants - Components used in the surgical fixation of the spinal skeletal system - Part 4: Metallic spinal rods
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	8,878
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Older Standard (superseded by this standard)	YY 0120-2002
Quoted Standard	YY/T 0119.1-2014; ASTM E122; ASTM F382
Regulation (derived from)	China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard applies to the spinal fixation implants longitudinal element metallic spinal rod. This Standard specifies the classification of metal spinal rod, materials and performance requirements.