Standard No.:	YY/T 0870.3-2019
English Name:	Test for genotoxicity of medical devices―Part 3:TK gene mutation test using mouse lymphoma cells
Chinese Name:	医疗器械遗传毒性试验 第3部分：用小鼠淋巴瘤细胞进行的TK基因突变试验
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:	National Medical Products Adminstration
Issued on:	2019-07-24
Implemented on:	2020-8-1
Status:	valid
Superseding:	YY/T 0870.3-2013 Test for genotoxicity of medical devices - Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cell
Language:	English
File Format:	PDF
Word Count:	10500 words
Price(USD):	315.00
Delivery:	via email in 1~5 business day

本标准规定了使用小鼠淋巴瘤细胞系（L5178Y TK+/-3.7.2C）进行医疗器械/材料体外哺乳动物细胞基因突变试验的方法。本标准适用于采用微孔板法，使用小鼠淋巴瘤细胞系（L5178Y TK+/-3.7.2C）进行TK基因突变试验，采用相对存活率（RS）和相对总生长（RTG）两种指标来评估细胞毒性的方法。本标准代替YY/T 0870.3-2013《医疗器械遗传毒性试验 第3部分：用小鼠淋巴瘤细胞进行的体外哺乳动物细胞基因突变试验》。