YY 0648-2008 (English Version) PDF

Scope: Except for the following content, this chapter in GB 4793.1 applies. Replacement: This standard applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-testing IVD medical purposes. In vitro diagnostic medical devices, whether used alone or in combination, are intended by the manufacturer to be used for the examination of in vitro samples, including blood and tissue samples from the human body, for the sole or primary purpose of providing information on one or more of the following: 　•A a physiological or pathological condition; or • a congenital anomaly; 　•determination of safety and compatibility of potential receptors; 　•monitoring of therapeutic measures. Self-testing in vitro diagnostic medical devices are intended by the manufacturer for use by laypeople in a home environment. Addition of equipment not included in the scope of this standard: Add the following second paragraph: Products used in general laboratories are not in vitro diagnostic medical devices unless, based on their characteristics, these products are specifically intended by the manufacturer for use in in vitro diagnostic examinations.

YY 0648-2008 Referenced Document

GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
YY/T 0316-2003 Medical devices-Application of risk management to medical devices

2008 YY 0648-2008 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment