Standard No.:	YY 0487-2004
English Name:	Sterrile,single-use hydrocephalus shunts and components
Chinese Name:	一次性使用无菌脑积水分流器及其组件
Chinese Classification:	C48    Medical sanitary products
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:	China Food and Drug Administration
Issued on:	2004-07-16
Implemented on:	2005-8-1
Status:	superseded
Superseded by:	YY/T 0487-2010 Sterile,single-use hydrocephalus shunts and components
Superseded on:	2012-6-1
Language:	English
File Format:	PDF
Word Count:	8000 words
Price(USD):	240.0
Delivery:	via email in 1~3 business day

本标准规定了一次性使用无菌脑积水分流器及其组件的要求。本标准适用于但不仅限于：a)完成的单件式一次性使用无菌脑积水分流器；b)完成的多件式一次性使用无菌脑积水分流器，由制造商装配好供应，或成套供应由医生装配；c)无菌一次性使用分流器的组件(单独或配套)。如阀、有阀导管(带阀导管)、进口导管或出口导管(如动脉导管、腹膜导管、静脉导管)、连接器、植人性辅助装置(如防虹吸装置、测量装置和储液器、灌注装置)。