SS-EN-ISO-11197 › Medical supply units (ISO 11197:2019)
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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.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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Designation Name
SS-EN ISO 11197:2019
Revision Level
2019 EDITION
Status
Current
Publication Date
Dec. 2, 2019
Language(s)
English
Page Count
48
International Equivalent
EN ISO 11197:2019(IDT); ISO 11197:2019(IDT)