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Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment211 Measurement)

机译：行业指南：诊断心电图指导（包括非报警sT段211测量）

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;Contents: Scope; Recommended Information and Testing (Device Description,211u001eComparison to Predicate, Performance Testing); In-Vitro Safety Testing 211u001e(Environmental Testing, Software, Electrical Safety, Electromagnetic 211u001eCompatibility); Labeling; Regulatory Requirements; References.

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年度 1998
页码 1-14
总页数 14
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Electrocardiographs; Medical devices; Diagnostic equipment; Guidance; Circulatory211 system devices; Cardiac monitors; In vitro analysis; Performance testing; Labeling; 211 Regulations;

机译：心电图仪;医疗设备;诊断设备;指导; Circulatory211系统设备;心脏监护仪;体外分析;性能测试;标签; 211法规;

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1. Industry: Upcoming Diagnostics Guidance Should be Risk-Based [J] . Virgil Dickson Washington Drug Letter . 2011,第20期

机译：行业：即将出台的诊断指南应基于风险
2. QT interval variability in body surface ECG: measurement, physiological basis, and clinical value: position statement and consensus guidance endorsed by the European Heart Rhythm Association jointly with the ESC Working Group on Cardiac Cellular Electrophysiology [J] . Baumert Mathias, Porta Alberto, Vos Marc A., Europace: European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology . 2016,第6期

机译：体表ECG的QT区间变异性：测量，生理基础和临床价值：由欧洲心律协会和ESC细胞心电生理学工作组共同认可的立场声明和共识性指导
3. Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays [J] . Biotechnology Law Report . 2007,第2期

机译：工业，临床实验室和FDA工作人员指南草案：体外诊断多元指标分析
4. Optimisation of The Design of Daylight Guidance Systems Including Measurement Methodology [C] . Lenka Janeckova, Daniela Bosova Building Performance Simulation Conference . 2013

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5. Guidance assistance, autonomous guidance and assisted distance guidance in precision agriculture. [D] . Gomez Gil, Jaime. 2005

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6. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: Drug Products Including Biological Products that Contain Nanomaterials [O] . Jon S. B. de Vlieger, Daan J. A. Crommelin, Katherine Tyner, -1

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7. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials” [O] . Jon S. B. de Vlieger, Daan J. A. Crommelin, Katherine Tyner, 2019

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8. Guidance for Industry: Cardiac Monitor Guidance (Including Cardiotachometer and211 Rate Alarm) [R] . 1998

机译：行业指南：心脏监护仪指导（包括心率计和211速率报警）

Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment211 Measurement)

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