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IEC 61010-2-040

Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

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Organization: IEC
Publication Date: 1 May 2020
Status: active
Page Count: 78
ICS Code (Electrical and electronic testing): 19.080
ICS Code (Chemical laboratories. Laboratory equipment): 71.040.10
scope:

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

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.

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).

Aspects included in scope

g) liberated gases (including the non-intentional escape of toxic gas), pathogenic substances, explosion and implosion (see Clause 13).

Aspects excluded from scope

aa) special requirements for protection against chemical and high-risk micro-biological HAZARDS associated with the LOAD;

bb) general requirements for the design of calorifiers, shell boilers and PRESSURE VESSELS.

NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and PRESSURE VESSELS (see 14.101).

Document History

IEC 61010-2-040
May 1, 2020
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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,...
July 1, 2015
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
Scope and object  Equipment included in scope Replacement: This International Standard specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection...
April 1, 2005
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
Scope and object  This clause of Part 1 is applicable except as follows: Equipment included in scope Replacement: This International Standard specifies safety requirements for electrical equipment...

References

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