CENELEC - EN 61010-2-101
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
|Publication Date:||1 February 2017|
|ICS Code (Electrical and electronic testing):||19.080|
|ICS Code (Diagnostic equipment):||11.040.55|
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, considerations have to be given to those other part 2 standards.
Equipment excluded from scope
This standard does not apply to equipment within the scope of:
a) IEC 60065 (Audio, video and similar electronic apparatus);
b) IEC 60204 (Safety of machinery - Electrical equipment of machines);
c) IEC 60335 (Household and similar electrical appliances);
d) IEC 60364 (Electrical installations of buildings);
e) IEC 60439 (Low-voltage switchgear and controlgear assemblies);
f) IEC 60601 (Medical electrical equipment);
g) IEC 60950 (Information technology equipment including electrical business equipment, except as specified in 1.1.3);
h) IEC 61558 (Power transformers, power supply units and similar);
i) IEC 61010-031 (Hand-held probe assemblies);
j) IEC 61243-3 (Live working - Voltage detectors - Part 3: Two-pole low-voltage type).
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.
This standard applies only to computers, processors, etc. which form part of equipment within the scope of this standard or are designed for use exclusively with the equipment.
NOTE Computing devices and similar equipment within the scope of IEC 60950 and conforming to its requirements are considered to be suitable for use with equipment within the scope of this standard. However, some of the requirements of IEC 60950 for resistance to moisture and liquids are less stringent than those in this standard (see 5.4.4 second paragraph)).
Aspects included in scope
bb) hazardous chemical substances.
Aspects excluded from scope
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.