Ventiladores pulmonares para uso médico. Parte 3: Requisitos particulares para ventiladores de emergencia y transporte.
Objeto y campo de aplicación
NOTE See the rationale in annex M. This part of ISO 10651 is one of a series of lnternational Standards based on IEC 6011:1988 (the "General Standard"); this type of lnternational Standard is referred to as a "Particular Standard". As stated in 1.3 of IEC6011:1988, the requirements of this part of ISO 10651 take precedence over those of IEC 6011 :1988. Where this part of ISO 10651 specifies that a clause of IEC 6011 applies, it mea ns that the clause applies only if the requirement is relevant to the ventilator under consideration. This part of ISO 10651 has common requirements with IEC 601212. lt also includes requirements from ISO 106511:1993. The scope and object given in clause 1 of IEC 6011 :1988 apply, except that 1.1 shall be replaced by the following: This part of ISO 10651 specifies requirements for portable lung ventilators designed for use in emergency situations and transport. Emergency and transport ventilators, called hereafter "ventilator". are often installed in ambulances or other types of rescue vehicles, but are often used outside this environment, where they have to be carried by the operator or other persons. These devices will frequently be used outside the hospital or home by personnel with different levels of training. This part of ISO 10651 is also applicable to devices permanently mounted in ambulances or aircraft. This part of ISO 10651 does not cover operatorpowered ventilators (i.e. manual resuscitators).
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Normas de Referencia
ISO 32:1977, ISO 53561: 1996, ISO 53562: 1987, ISO 5358: 1992,ISO 5362: 1986, ISO 5367:1991, ISO 7767: 1 l, ISO 9170: 1990, ISO 97031: 1992, ISO 97032:1994, ISO 106511: 1993, IEC 6826: 1982, IEC 68229:1987, IEC 68232:1990, IEC 68236:1983, IEC 794: 1975, IEC 6011: 1988, IEC 60112: 1993