DANSK DS/EN IEC 61010-2-040 PDF

This clause of Part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the existing text with the following: 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 Addition: Add the following note to item f): 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. Addition: Add the following new second paragraph after the lettered list: 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 Replacement: Replace item g) with the following new text: g) 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 Addition: Add the following two new items: 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).