IEC 61010-2-040:2020
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
IEC 61010-2-040:2020 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:- sterilizers and disinfectors using steam and/or hot water as the sterilant;- sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;- sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and- washer-disinfectors.This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:- it is established on the basis of the third edition (2010) of IEC 61010?1 and its Amendment 1 (2016);- added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;- the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).
IEC 61010-2-040:2020 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:
- sterilizers and disinfectors using steam and/or hot water as the sterilant;
- sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;
- sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and
- washer-disinfectors.
This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- it is established on the basis of the third edition (2010) of IEC 61010?1 and its Amendment 1 (2016);
- added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;
- the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).
IEC 61010-2-040:2015 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. It has the status of a group safety publication, as specified in IEC Guide 104. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) A new clause (4.3.2.101) has been added for non-electrical supplies and services. b) Additional requirements for marking and documentation (Clause 5) have been added. c) Additional requirements for protection against mechanical hazards (Clause 7) have been included. d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included.
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