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Norm
ÖNORM EN ISO 11197
Issue date: 2020 05 01
Medical supply units (ISO 11197:2019)
IEC 60601-1:2005+A1:2012, Clause 1 applies except as follows:
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential perf...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 40 Pages
Language:
German
| English
Optionally co-design standards:
ICS
IEC 60601-1:2005+A1:2012, Clause 1 applies except as follows:
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.
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.
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