YY/T 0119.1-2014: Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 1: General requirements

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Scope

This Part of YY/T 0119 specifies the general terms used to describe the
dimensions and other physical characteristics of the components used in the
surgical fixation of the spinal skeletal system. It also specifies the requirements
for materials, manufacturing, sterilization, packaging, and information provided
by the manufacturer for the components used in the surgical fixation of the
spinal skeletal system.

Basic Data

Standard ID	YY/T 0119.1-2014 (YY/T0119.1-2014)
Description (Translated English)	Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 1: General requirements
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	15,162
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Older Standard (superseded by this standard)	YY 0119-2002; YY 0120-2002
Quoted Standard	GB 4234; GB/T 10623; GB/T 13810; GB/T 16825.1; GB 23102; YY/T 0119.2-2014; YY/T 0119.3-2014; YY/T 0119.4-2104; YY/T 0640-2008; YY/T 0857; YY/T 0961; ISO 5832-2; ISO 5832-3; ASTM F382; ASTM F543; ASTM F1582
Adopted Standard	ASTM F2193-2007, IDT
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 individual components within the spinal fixation system in use. This Standard specifies to describe the materials, manufacturing, sterilization, packaging and manufacturer generic term spinal fixation system component dimensions a