Standard No.:	YY/T 0878.3-2019
English Name:	Test for complement activation of medical devices―Part 3：Assay for the product of complement activation (C3a and SC5b-9)
Chinese Name:	医疗器械补体激活试验 第3部分：补体激活产物（C3a和SC5b-9）的测定
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
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2019-07-24
Implemented on:	2020-8-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1~3 business day

本标准规定了用酶联免疫法测定血液中补体激活产物（C3a和SC5b-9）的方法。本标准适用于体外对医疗器械/材料补体激活潜能的评价。本标准中建立的试验体系适用于人血清或抗凝血浆。若使用动物血液，经论证其适宜性后进行试验。