Término solicitado: RESPIRADORES/(265,65,175)
3 Registro/s encontrado/s en CAT+NORMA
| Tipo de documento: | NORMA |
| Título: | MEDICAL ELECTRICAL EQUIPMENT -- PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| Código de Doc.: | ISO 80601-2-55 |
| Autor Inst.: | International Organization for Standardization. ISO |
| Fecha: | 2011 |
| Estado: | Para datos sobre la vigencia de esta norma haga clic aquí |
| Objeto: | ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient. ISO 80601-2-55:2011 specifies requirements for: Ýanaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring |
| Campo de Aplic.: | ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents |
| ICS: | 11.040.10 |
| Idioma: | en |
| Título en otro Idioma: | Appareils électromédicaux -- Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires |
| Edición: | first edition |
| Palabras Clave: | Medicina; Equipos electromédicos; Equipos médicos; Requisitos; Seguridad; Respiradores; Monitor de gas respiratorio; Vigilancia; Gases anestésicos; Dióxido de carbono; Oxígeno |
| Páginas: | 52p. |
| Ingreso de la Info.: | 2012-02-22 |
| Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento: | NORMA |
| Título: | MEDICAL ELECTRICAL EQUIPMENT -- PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
| Código de Doc.: | ISO 80601-2-13 |
| Autor Inst.: | International Organization for Standardization. ISO |
| Fecha: | 2011 |
| Estado: | Para datos sobre la vigencia de esta norma haga clic aquí |
| Objeto: | ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system;anaesthetic breathing system;anaesthetic gas scavenging system;anaesthetic vapour delivery system;anaesthetic ventilator;monitoring equipment;alarm system;protection device |
| Campo de Aplic.: | ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.ISO/IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components 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 an anaesthetic workstation and its individual components, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB |
| ICS: | 11.040.10 |
| Idioma: | en |
| Título en otro Idioma: | Appareils électromédicaux -- Partie 2-13: Exigences particulières de sécurité de base et de performance essentielle pour les systèmes d'anesthésie |
| Edición: | first edition |
| Palabras Clave: | Medicina; Equipos electromédicos; Equipos médicos; Requisitos; Seguridad; Performance; Puestos de trabajo; Anestesia; Respiradores |
| Páginas: | 99p. |
| Ingreso de la Info.: | 2011-09-09 |
| Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento: | NORMA |
| Título: | MEDICAL ELECTRICAL EQUIPMENT -- PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| Código de Doc.: | ISO 80601-2-12 |
| Autor Inst.: | International Organization for Standardization. ISO |
| Fecha: | 2011 |
| Estado: | Para datos sobre la vigencia de esta norma haga clic aquí |
| Objeto: | ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility |
| Campo de Aplic.: | ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. 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. ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6 |
| ICS: | 11.040.10 |
| Idioma: | en |
| Título en otro Idioma: | Appareils électromédicaux -- Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs |
| Edición: | first edition |
| Palabras Clave: | Medicina; Equipos electromédicos; Equipos médicos; Requisitos; Seguridad; Respiradores; Ventilación mecánica; Cuidados intensivos |
| Páginas: | 78p. |
| Ingreso de la Info.: | 2011-07-05 |
| Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
Fin
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