Standard Number: YY 0648-2008(YY0648-2008)
Chinese:测量、控制和实验室用电气设备的安全要求 第2-101部分：体外诊断(IVD)医用设备的专用要求
English:Safety requirements for electrical equipment for measurement,control and laboratory use-Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment
Effective Date:2009-12-01
ICS:11.000
Standard Applicability:Replacement. This standard applies to equipment intended to be used for in vitro diagnostic (IVD) medical purposes, including self-testing in vitro diagnostic medical purposes. In vitro diagnostic medical devices, whether used singly or in combination, are devices intended by the manufacturer to be used for the examination of in vitro samples, including blood and tissue samples from the human body, which are intended, singly or principally, to provide information about one or more of the following: a physiologic or pathologic condition; or a congenital abnormality; to determine the safety and compatibility of potential receptors; and to monitor therapeutic interventions. Self-testing in vitro diagnostic medical devices are intended by the manufacturer to be used by non-specialists in the home environment. NOTE:If all or a part of a device falls within the scope of this standard and at the same time falls within the scope of one or more other GB 4793-specific standards, this device is also subject to the requirements of those other specific standards.
ADD. Add the following second paragraph. Products for general laboratory use are not in vitro diagnostic medical devices unless, by their characteristics, they are specifically intended by the manufacturer for use in in vitro diagnostic tests.
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