Standard No.:	YY/T 1768.1-2021
English Name:	Needle-based injection systems for medical use—Requirements and test methods—Part 1:Needle-based injection systems
Chinese Name:	医用针式注射系统 要求和试验方法 第1部分：针式注射系统
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Issued by:	National Medical Products Adminstration
Issued on:	2021-03-09
Implemented on:	2022-4-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	20000 words
Price(USD):	600.00
Delivery:	via email in 1~5 business day

本标准规定了针式注射系统的要求和试验方法。
本标准适用于预期与针头和容器一起使用的针式注射系统，例如笔式注射器。本标准中所述的容器包括由制造商或最终用户充装的单剂量、多剂量注射器系统和卡式瓶系统。
本标准不适用于无针注射器。
本标准不涉及由最终用户充装容器和器具的要求和相关方法。