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

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Scope

Except for the following, this chapter in GB 47.93.1 applies.
1.1 Scope
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This standard applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-testing in vitro diagnostic medical purposes.
In vitro diagnostic medical devices, whether used alone or in combination, are intended to be used by manufacturers for the examination of in vitro samples, including those from humans
Blood and tissue samples from individuals, whose sole or main purpose is to provide information for one or more of the following.
● a physiological or pathological condition; or
● a congenital anomaly;
● determine the safety and compatibility of potential receptors;
● Monitoring of treatment measures.
Self-testing in vitro diagnostic medical devices are intended for use by manufacturers in non-professional home environments.
Note. If all or a part of the equipment belongs to the scope of this standard, and also belongs to the scope of one or several other GB 4793 special standards, this equipment
Equipment also needs to meet the requirements of those other specific standards.
1.1.2 Equipment not covered by this standard
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Add the second paragraph below.
Products used in general laboratories are not in vitro diagnostic medical devices, unless they are specifically expected by the manufacturer based on their characteristics
For in vitro diagnostic tests.
1.2 Purpose
1.2.1 Contents included in the scope of this standard
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Replace the first sentence with the following.
The purpose of this standard is to ensure that the design and construction methods used are at an acceptable level of risk for the operator and the surrounding environment.
Provide a high degree of protection and use risk management where appropriate (see Appendix AA).
increase.
Add two new entries.
h) biological hazards;
i) Hazardous chemicals.
1.2.2 Contents not included in the scope of this standard
increase.
Add a new entry and the following note.
g) Treatment or manipulation of the material being analyzed outside the equipment.
Note. The requirement to cover these disciplines is the responsibility of the committee that develops the appropriate standards.
YY 0648-2008/IEC 61010-2-2101..2002

Basic Data

Standard ID	YY 0648-2008 (YY0648-2008)
Description (Translated English)	Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	16,180
Date of Issue	2008-04-25
Date of Implementation	2009-12-01
Quoted Standard	YY/T 0316-2003
Adopted Standard	IEC 61010-2-101-2002, IDT
Regulation (derived from)	SFDA [2008] No. 192
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard is expected to be used for in vitro diagnostic (IVD) medical purposes, including the purpose of self-vitro diagnostic medical devices.