检测
医疗器械
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对无创血压测量，FDA产品代码的查询结果如下：
Devicesystem, measurement, blood-pressure, non-invasiveRegulation DescriptionNoninvasive blood pressure measurement system.Regulation Medical SpecialtyCardiovascularReview PanelCardiovascularProduct CodeDXNSubmission Type510(k)Regulation Number870.11306Device Class2Total Product Life Cycle (TPLC)TPLC Product Code Report7GMP Exempt?NoRecognized Consensus StandardsSP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers8
AAMI/ANSI/IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers9
AAMI/ANSI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type10
· ISO 81060-2 First edition 2009-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type11由于目前FDA还没有开始强制实施第3版本的通标，在2013年6月30日之前，对于电子血压计或血压监护类设备，旧版的专标（ANSI/AAMI SP10）和 通标(第2版)的报告都接受。目前适用的标准检测组合参考如下：基于振荡法测量原理的 电子血压计和血压监护设备 适用的通标和专标采用旧版标准采用新版标准通用标准IEC 60601-1:1988/A1:1991/A2:1995IEC 60601-1:2005专用标准 +临床要求ANSI/AAMI SP10:2002/ A2:2006/(R)2008AAMI/ANSI/IEC 80601-2-30:2009AAMI/ANSI/ISO 81060-2:2009