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Biological evaluation for nanomaterial medical devices—Testing and characterization methods for silver nanoparticles and ions released from silver nanoparticle containing dressing
Standard in brief
Scope of Application：
本文件规定了评价含纳米银敷料在释放介质中释放纳米银颗粒和银离子的实验方法，以及释放液中纳米银颗粒和银离子的分离、测定和表征方法。
本文件适用于与体表创面接触的含纳米银敷料的纳米银颗粒及银离子的释放特性评价。
Basic information
Standard No：YY/T 1863-2023
Standard Name：纳米医疗器械生物学评价 含纳米银敷料中纳米银颗粒和银离子的释放与表征方法
English Name：Biological evaluation for nanomaterial medical devices—Testing and characterization methods for silver nanoparticles and ions released from silver nanoparticle containing dressing
Standard Status：现行
Release Date：2023-01-13
Effective Date：2024-01-15
Language of Publication：中文简体
Standard Classification
ICS Number：11.040.30
CCS Number：C30
Related Standards
Referenced Standards：GB/T 6682,GB/T 36083,GB/T 38261-2019,ISO 19430,ISO/TS 19590,中华人民共和国药典
Publication Information
Number of pages：20
Number of words：34 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2023-02-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：1863
Drafter：陈亮、柳琳、吴美玉、刘颖、徐丽明、谢黎明、王小蕾、陈春英、白茹
Drafting Organization：中国食品药品检定研究院、国家纳米科学中心
Management Organization：全国医疗器械生物学评价标准化技术委员会纳米医疗器械生物学评价分技术委员会(SAC/TC 248/SC 1)
Proposing Department：国家药品监督管理局
