UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

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 washerdisinfectors used to treat medical materials

active, Most Current
Buy Now
Organization: CSA
Publication Date: 1 January 2021
Status: active
Page Count: 100
ICS Code (Electrical and electronic testing): 19.080
ICS Code (Chemical laboratories. Laboratory equipment): 71.040.10
scope:

Scope and object

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

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

CSA C22.2 NO 61010-2-040
January 1, 2021
Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-040: Particular requirements for sterilizers and washerdisinfectors used to treat medical materials
Scope and object Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials...
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,...
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...
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

Advertisement