YY/T 1897-2023 English Version, YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test (English Version)

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YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test (English Version)
Standard No.:	YY/T 1897-2023	Status:	valid remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	6500 words	Translation Price(USD):	195.0 remind me the price change Email:
Implemented on:	2024-7-1	Delivery:	via email in 1~3 business day

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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
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2023-06-20
Implemented on:	2024-7-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	6500 words
Translation Price(USD):	195.0
Delivery:	via email in 1~3 business day

Standard

YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test (English Version)
Standard No.	YY/T 1897-2023
Status	valid
Language	English
File Format	PDF
Word Count	6500 words
Price(USD)	195.0
Implemented on	2024-7-1
Delivery	via email in 1~3 business day

Detail of YY/T 1897-2023

Standard No.

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Keywords

Introduction of YY/T 1897-2023

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。

Contents of YY/T 1897-2023

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