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Description / Abstract:
Equipment included in scope
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 given to those other part 2
standards.
Equipment excluded from scope
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.
aa) biohazards;
bb) hazardous chemical substances.
Aspects excluded from scope
Addition: Add the following item and note:
aa) the handling or manipulation outside the equipment of
material under analysis.
NOTE Requirements covering these subjects are the responsibility
of committees preparing relevant standards.