UL 60601-1:2003

UL 60601-1:2003

Medical Electrical Equipment, Part 1: General Requirements for Safety

846,00 €

Detalles

This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15).



Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.



SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered.



Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.



1.1DV Replacement of the third paragraph of 1.1 with the following:



SAFETY HAZARDS resulting from intended physiological function of EQUIPMENT covered by this Standard are not considered. These requirements do not contemplate the investigation of protection against ionizing radiation or radioactive isotopes. Such EQUIPMENT is subject to Federal radiation Standards ( 21CFR Part 1020) promulgated under the Radiation Control for Health and Safety Act of 1968.



1.2 Object



The object of this Standard is to specify general requirements for the safety of MEDICAL ELECTRICAL EQUIPMENT and to serve as the basis for the safety requirements of Particular Standards.

1.3 *Particular Standards



A Particular Standard takes priority over this General Standard.

1.4 Environmental conditions



See Section Two.

1.5 Collateral Standards



In the IEC 601 series, Collateral Standards specify general requirements for safety applicable to:



– a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment),



– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT not fully addressed in the General Standard (e.g. electromagnetic compatibility).



If a Collateral Standard applies to a Particular Standard, then the Particular Standard takes priority over the Collateral Standard.

Información adicional

Autor Underwriters Laboratories (UL)
Publicado por UL
Tipo de Documento Norma
Edición 1
ICS 11.040.01 : Equipo médico en general
Número de páginas 332
Reemplaza UL 2601-1 (1997-10-24)
modificado por Révisions (2003-06-30), (2006-04-26)
Peso(kg.) 0.6644
Palabra clave UL 60601-1