IEC 60601-1:2005+A1:2012, 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.ISO 11197:2016 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.
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.
ISO 11197:2016 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.
ISO 11197:2004 specifies requirements and test methods for medical supply units intended for use in healthcare facilities to supply electric power and/ medical gases and/or liquids and anaesthetic gas scavenging systems. It is applicable in conjunction with IEC 60601-1:1988. The requirements of ISO 11197:2004 take priority over those of IEC 60601-1:1988.
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.
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