Standard No.:	YY/T 0879.1-2013
English Name:	Test for sensitization of medical devices - Part 1: Murine local lymph node assay (LLNA), radioisotope incorporation method
Chinese Name:	医疗器械致敏反应试验 第1部分：小鼠局部淋巴结试验(LLNA)放射性同位素掺入法
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:	SDA
Issued on:	2013-10-21
Implemented on:	2014-10-1
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

本标准给出了医疗器械/材料致敏试验的检测方法。本标准预期为豚鼠致敏试验提供一个替代性方法，尤其适用于只接触完好皮肤的医疗器械/材料。然而，当评定金属材料或用于深部组织或损伤表面医疗器械产品/材料的致敏反应时，仍然推荐使用豚鼠致敏试验。本标准只适用于能浸入皮肤的低分子量化学物，该吸收的化学物或代谢物可结合于大分子物质，如蛋白质以形成免疫原性复合物。