prEN ISO 11197
Medical supply units (ISO/DIS 11197:2024)
Draft Public enquiryProject stage codes
1. Nauja darbo tema
2. Projektas
3. Viešoji apklausa
From 2024-04-04
till 2024-06-13
4. Closure of enquiry
5. Projekto priėmimas
Organisation
CEN Europos standartizacijos komitetasICS
11.040.01 - Medical equipment in generalTechnical Committee
TK 32 HealthForeignTC'S
CEN/TC 215Number of comments
0Comment start date
2024-04-04Scope
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.Relations
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