GSO IEC 61010-2-101:2014
Gulf Standard
Current Edition
·
Approved on
25 December 2014
·
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
GSO IEC 61010-2-101:2014 Files
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GSO IEC 61010-2-101:2014 Scope
This clause of Part 1 is applicable except as follows:
1.1.1 Equipment included in scope
Replacement:
Replace the text by the following:
This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical
purposes, including self-test IVD medical purposes.
IVD medical equipment, whether used alone or in combination, is intended by the
manufacturer to be used in vitro for the examination of specimens, including blood and tissue
samples, derived from the human body, solely or principally for the purpose of providing
information concerning one or more of the following:
• a physiological or pathological state; or
• a congenital abnormality;
• the determination of safety and compatibility with potential recipients;
• the monitoring of therapeutic measures.
Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a
home environment.
NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 as
well as within the scope of this standard, considerations have to be given to those other part 2 standards.
1.1.2 Equipment excluded from scope
Addition:
Add the following item:
aa) Equipment in the scope of IEC 61010-2-081 unless they are specifically intended by
their manufacturer to be used for in vitro diagnostic examination.
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