Evaluation,Guidance GHTF医疗器械临床评价是在 医疗器械安 全与性能基本要求 体系框架下建立的评价体系。 临床评价开始之前,需对照安全与性能基本要求 特征判定列表,鉴别哪些安全和/或性能需要临 床相关数据支持,依据其确定临床评价范围。通 过数据鉴别、数据评价、数据分析的过程最终形 成临床评价报告,而临床评价报告和...
UDIAHWGDraftGuidanceforGHTFSC介绍.doc,GHTF/AH(PD1)N2:R1 GHTF关于医疗器械 UDI系统的讨论稿(指南草案) 题目: 医疗器械唯一性标识(UDI)系统 起草单位: GHTF SC UDI AHWG 由全球医疗器械法规协调组织提议,以征询公众意见 意见提交最后期限: 2010年 3月31日 提交意
(USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use ...
从陆地棉中克隆了磷脂酰乙醇胺结合蛋白GhTFL1a和GhTFL1c基因, 并对该基因进行表达分析、启动子预测和启动子活性研究。利用启动子分析软件PlantCARE预测得出,GhTFL1a启动子区域有脱落酸响应元件、干旱诱导的MYB结合位点和顶芽特异表达响应元件等;GhTFL1c启动子区域有乙烯响应元件、干旱诱导的MYB结合位点和水杨酸响应元件。因此...
Date:February 18, 2010 Dr. Larry Kelly, GHTF Chair The document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from medical device regulatory agencies and the regulated industry. The document is intended to providenon-bindingguidance for use in the...
ISO/TR 16142:2006 Medical Devices – Guidance on the Selection of Standards in Support of the Recognized Essential Principles of Safety and Performance of Medical Devices. Definitions Analytical performance: the ability of an IVD medical device to detect or measure a particular analyte. Clinical dat...
The document is intended to provide non-binding guidance for use in the regulation of medical 3 devices, and has been subject to consultation throughout its development. 4 There are no restrictions on the reproduction, distribution or use of this document; however, in- 5 ...
The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in ...
The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in ...