CEI EN IEC 61010-2-040 PDF

Equipment included in scope

This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4.

Examples of such equipment include the following:

a) STERILIZERS and disinfectors using steam and/or hot water as the sterilant;

b) STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;

c) STERILIZERS and disinfectors using hot air or hot inert gas as the sterilant; and

d) WASHER-DISINFECTORS.

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);

NOTE IEC 60601-1:2005, 3.63, defines "medical electrical equipment" as follows (notes to entry are omitted):

Electrical equipment, having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:

a) provided with not more than one connection to a particular supply MAINS; and

b) intended by its manufacturer to be used:

1) in the diagnosis, treatment, or monitoring of a patient; or

2) for compensation or alleviation of disease, injury or disability.

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).

This document does not apply to the following types of equipment:

aa) equipment for use in hazardous atmospheres (see IEC 60079); however this document does apply to an atmosphere created inside equipment by a flammable sterilizing agent (see 13.2.101 and 13.2.102);

bb) laboratory equipment for the heating of materials for purposes other than sterilization or disinfection (see IEC 61010-2-010);

cc) laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and ISO 10472 (all parts)), unless designed for disinfecting medical materials;

dd) dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).

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)).