93/44/EEC - Machinery - Safety of machinery: appliances for the lifting or moving of persons (Dir. 89/392/EEC amendment)

IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-35:2020 does not apply to: - HEATING DEVICES intended for physiotherapy; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - cooling devices. IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients. It contains requirements for the patient’s compartment.
This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.
This European Standard is applicable to road ambulances capable of transporting at least one person on a stretcher.
Requirements are specified for categories of road ambulances based in increasing order of the level of treatment that can be carried out. These are the patient transport ambulance (types A1 A2), the emergency ambulance (type B) and the mobile intensive care unit (type C).
This European Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.

This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients. It contains requirements for the patient’s compartment.
This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.
This European Standard is applicable to road ambulances capable of transporting at least one person on a stretcher.
Requirements are specified for categories of road ambulances based in increasing order of the level of treatment that can be carried out. These are the patient transport ambulance (types A1 A2), the emergency ambulance (type B) and the mobile intensive care unit (type C).
This European Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.