International Organization for Standardization

Medical supply units - Third Edition
 N 11197

Annotation

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS,hereafter also referred to as ME EQUIPMENT

This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site, including cabinetry and other ENCLOSURES, which incorporate PATIENT care services.

NOTE 1 A party that assembles on site various components intended for PATIENT care services into an ENCLOSURE is considered the MANUFACTURER of the MEDICAL SUPPLY UNIT.

HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601 1:2005+A1:2012 (see 201.1.4).

NOTE 2 See also IEC 60601 1:2005+A1:2012, 4.2.

Автоматический перевод:

Единицы медицинского обеспечения - Третий Выпуск

IEC 60601-1:2005+A1:2012, 1.1 заменяется:

Этот Международный стандарт относится к BASIC SAFETY и ESSENTIAL PERFORMANCE MEDICAL SUPPLY UNITS, после этого также называемые ME EQUIPMENT

Этот Международный стандарт относится к MEDICAL SUPPLY UNITS, произведенные в производственном предприятии или собранные на территории, включая искусство краснодеревщика и другие ENCLOSURES, включающие услуги УХОДА ЗА БОЛЬНЫМ.