prEN ISO 11197
Medicininiai maitinimo blokai (ISO/DIS 11197:2024)
Standarto projektas Viešoji apklausaProjekto etapai
1. Nauja darbo tema
2. Projektas
3. Viešoji apklausa
Nuo 2024-04-04
iki 2024-06-13
4. Closure of enquiry
5. Projekto priėmimas
Organizacija
CEN Europos standartizacijos komitetasICS
11.040.01 - Medicinos įranga. Bendrieji dalykaiTechnikos komitetas
TK 32 SveikataUžsienio technikos komitetas
CEN/TC 215Komentarų skaičius
0Komentavimo pradžia
2024-04-04Taikymo sritis
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.Ryšiai
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