Standard No.:	YY/T 0878.1-2013
English Name:	Complement activation test for medical devices - Part 1: Serum complement activation
Chinese Name:	医疗器械补体激活试验 第1部分：血清全补体激活
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Issued by:	SDA
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5000 words
Price(USD):	150.00
Delivery:	via email in 1~3 business day

本标准给出了医疗器械体外全补体激活作用的试验方法，本方法适用于固态样品。本标准中，“血清”和“补体”可通用，意指将血清用作补体来源。本标准中未涉及单一补体成分的功能、修饰或消耗以及来源于血浆的补体。