DANSK DSF/FPREN ISO 80601-2-12 PDF

This document applies to the BASIC SAFETY and ESSENT IA L PERFORMANC E of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPME NT intended: -- for those P AT IENTS who can be dependent on artificial ventilation; -- for use in an environment, which provides specialized care of P ATIENTS whose condi tions can be life-threatening and who can require comprehensive care and constant monitoring in a PROFES S IONA L HE ALTHCARE FAC ILITY ; and NOTE 1 – For the purposes of this standard, this includes transport within a PROFESSIONAL HEALTHCARE FACILITY (i.e. a TRANSIT OPERABLE VENTILATOR). NOTE 2 – A critical care VENTILATOR intended for use in transport within a PROFESSIONAL HEALTHCARE FACILITY is not considered an emergency and transport ventilator. -- to be attended by a HE A LTHCARE PROFESSIO NAL O PERATOR. NOTE 3 – Such VENTILATORS are considered life-sustaining. NOTE 4 – For the purposes of this standard, such an environment is referred to as a critical care environment. This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYST EM, or to a VENTILAT OR, where the characteristi cs of those ACCESSORIES can affect the BASIC SAFETY or ES SEN TIAL PERFORM ANC E of the V ENT ILAT OR. If a clause or subclause is specifically intended to be applicable to ME E QUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause wi ll say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTE MS, as relevant. HAZARDS inherent in the intended physiological function of ME E QUIP MENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE 5 – Additional information can be found in IEC 60601-1:2005, 4.2.