scope:

Equipment included in scope

This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical committees in the preparation of their publications for products similar to those mentioned in the scope of this standard, in accordance with the principles laid down in IEC Guide 104 and lSO/lEC Guide 51.

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 the IEC 61010 series as well as within the scope of this document, consideration is 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 within the scope of IEC 61010-2-081 unless it is specifically intended by the manufacturer to be used for in vitro diagnostic examination.

Computing equipment

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)).