Equipos electromédicos. Parte 1-11: Requisitos generales para la seguridad básica y el funcionamiento esencial. Norma colateral: Requisitos para el equipo electromédico y el sistema electromédico utilizado para el cuidado en el entorno médico del hogar.

Objeto y campo de aplicación

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel. The HOME HEALTHCARE ENVIRONMENT includes:  the dwelling place in which a PATIENT lives;  other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard. EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the professional healthcare facility environment. NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

Información general

Código del comité
CTN N.A 
Nombre del comité
N.A 
Sector
Salud 
ICS
11.040  
Correspondencias
IEC 60601-1-11:2015  
Organismos
IEC  
Edición
Fecha de aprobación
2020-06-30 
Número de páginas
66 
Estado
Vigente 

Normas de Referencia
CISPR 11:2009, IEC 60068-2-27:2008, IEC 60068-2-31:2008, IEC 60068-2-64:2008, IEC 60529:1989, IEC 60529:1989/AMD1:1999 IEC 60529:1989/AMD2:2013 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013) IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 IEC 60601-1-12:2014, IEC 62366:2007, IEC 62366:2007/AMD1:2014 ISO 7000, ISO 7010:2011, ISO 7010:2011/AMD1:2012 ISO 7010:2011/AMD2:2012 ISO 7010:2011/AMD3:2012 ISO 7010:2011/AMD4:2013 ISO 7010:2011/AMD5:2014