GB 8662-1988
Replaced
YY/T 1863-2023
Active
Industry standards-Medicine
YY/T 1863-2023 Biological evaluation for nanomaterial medical devices—Testing and characterization methods for silver nanoparticles and ions released from silver nanoparticle containing dressing
YY/T 1863-2023 Biological evaluation for nanomaterial medical devices—Testing and characterization methods for silver nanoparticles and ions released from silver nanoparticle containing dressing
Basic Information
Standard Code:
YY/T 1863-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2023-01-13
Implement Date:
2024-01-15
Publisher:
国家药品监督管理局
Technical Committee:
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)
Pages:
20 pages
Scope
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。
Development Information
Drafting Units:
中国食品药品检定研究院、国家纳米科学中心
Drafting Persons:
陈亮、柳琳、吴美玉、刘颖、徐丽明、谢黎明、王小蕾、陈春英、白茹
Referenced Standards
GB/T 38261-2019 Nanotechnology—Determination of silver contents in biological samples—Inductively coupled plasma mass spectrometry
ISO 19430
ISO/TS 19590
中华人民共和国药典
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 36083-2018 Nanotechnology—Silver nanomaterials—Guidance for the characterization of biological effect-related physicochemical properties
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced