STN EN IEC 60601-2-16
| Označenie: | STN EN IEC 60601-2-16 |
| Platnosť: | Platná |
| Počet strán: | 112 |
| Jazyk: |
EN
|
| Listinná verzia: | 31,80€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
28,62€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 31,80€ c) S možnosťou tlače, prenosu textu a obrázkov: 41,34€ |
| Slovenský názov: | Zdravotnícke elektrické prístroje. Časť 2-16: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti hemodialyzačných, hemodiafiltračných a hemofiltračných prístrojov |
| Anglický názov: | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| Dátum vydania: | 01. 05. 2025 |
| Dátum zrušenia: | |
| ICS: | 11.040.20, 11.040.25 |
| Triediaci znak: | 36 4800 |
| Úroveň zapracovania: | idt EN IEC 60601-2-16:2025, idt IEC 60601-2-16:2025 |
| Vestník: | 04/25 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN IEC 60601-2-16:2019-11 (36 4800) |
| Poznámka vo Vestníku: | |
| Predmet normy: | IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into ... |
| Náhľad normy: | Náhľad normy (PDF) |