Standard No.:	YY/T 0726-2020
English Name:	Instrumentation for use in association with non-active surgical implants—Gerneral requirements
Chinese Name:	无源外科植入物联用器械 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
Issued by:	National Medical Products Adminstration
Issued on:	2020-06-30
Implemented on:	2021-6-1
Status:	valid
Superseding:	YY/T 0726-2009 Instrumentation for use in association with non-active surgical implants—General requirements
Language:	English
File Format:	PDF
Word Count:	8500 words
Price(USD):	255.00
Delivery:	via email in 1~3 business day

本标准规定了无源外科植入物联用器械的通用要求，包括预期性能、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。本标准适用于新生产的器械和返修后再供给的器械，也适用于与动力驱动系统相连接的器械。本标准不适用于动力驱动系统本身，也不适用于与齿科植入物、经牙髓牙根植入物和眼科植入物联用的器械。