Standard No.:	YY/T 0726-2009
English Name:	Instrumentation for use in association with non-active surgical implants—General requirements
Chinese Name:	与无源外科植入物联用的器械 通用要求
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
Source Content Issued by:	China Food and Drug Administration
Issued on:	2009-06-16
Implemented on:	2010-12-1
Status:	superseded
Superseded by:	YY/T 0726-2020 Instrumentation for use in association with non-active surgical implants—Gerneral requirements
Superseded on:	2021-6-1
Target Language:	English
File Format:	PDF
Word Count:	10000 words
Translation Price(USD):	280.0
Delivery:	via email in 1~5 business day

本标准规定了与无源外科植入物联用的器械的通用要求,这些要求适用于新生产的器械和返修后再供给的器械。
本标准适用于与动力驱动系统相连接的器械,但不适用于动力驱动系统本身。
关于安全方面,本标准规定了对预期性能、设计属性、材料选择、设计评估、制造、灭菌、包装和制造商提供信息的要求。
本标准不适用于与齿科植入物、经牙髓牙根植入固定物和眼科植入物相关的器械。