Standard No.:	YY/T 1897-2023
English Name:	Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
Chinese Name:	纳米医疗器械生物学评价 遗传毒性试验 体外哺乳动物细胞微核试验
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by:	National Medical Products Adminstration
Issued on:	2023-06-20
Implemented on:	2024-7-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	6500 words
Price(USD):	195.00
Delivery:	via email in 1~3 business day

本文件给出了评价纳米医疗器械或用于医疗器械的纳米材料的体外哺乳动物细胞微核试验方法，通过测定细胞暴露于纳米医疗器械或用于医疗器械的纳米材料供试液后的含微核细胞数，评价其是否具有潜在遗传毒性风险。
本文件适用于采用永生化细胞胞质分裂阻断法微核试验评价纳米医疗器械或用于医疗器械的纳米材料的遗传毒性。