标准编号：ISO 11197:2019
中文名称：医用供电装置
英文名称：Medical supply units
发布日期：2019-11
标准范围
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential performance of medical supply units, hereafter also
referred to as ME equipment.
This document 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
document are not covered by specific requirements in this standard, except in of IEC 60601-
1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.
立即下载标准文件