CSA C22.2 NO. 61010-2-040:21

This is the third edition of CSA C22.2 No. 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, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 61010-2-040 (third edition, 2020-05). It supersedes the previous edition published in 2016 as CAN/CSA-C22.2 No. 61010-2-040 (adopted IEC 61010-2-040:2015). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 61010-1:12, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1: General requirements (adopted IEC 61010-1:2010, with Canadian and US deviations); and Amendment 1:2018 to CAN/CSA-C22.2 No. 61010-1:12 (adopted IEC Amendment 1:2016, with Canadian and US deviations).

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope and object:

1.1.1 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.

1.1.2 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).

1.2.1 Aspects included in scope

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

1.2.2 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).