ISO/DIS 11197
Abstract
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.
General information
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Status: Under development
You can help develop this draft international standard by contacting your national member
Stage: DIS ballot initiated: 12 weeks [40.20] -
Edition: 5Number of pages: 42
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Technical Committee :ISO/TC 121/SC 6ICS :11.040.01
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Life cycle
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PublishedISO 11197:2019
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