STN EN IEC 60601-2-39
| Označenie: | STN EN IEC 60601-2-39 |
| Platnosť: | Platná |
| Počet strán: | 64 |
| Jazyk: |
EN
|
| Listinná verzia: | 24,40€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
21,96€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 24,40€ c) S možnosťou tlače, prenosu textu a obrázkov: 31,72€ |
| Slovenský názov: | Zdravotnícke elektrické prístroje. Časť 2-39: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti prístrojov na peritoneálnu dialýzu |
| Anglický názov: | Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment |
| Dátum vydania: | 01. 05. 2025 |
| Dátum zrušenia: | |
| ICS: | 11.040.99 |
| Triediaci znak: | 36 4800 |
| Úroveň zapracovania: | idt EN IEC 60601-2-39:2025, idt IEC 60601-2-39:2024 |
| Vestník: | 04/25 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN IEC 60601-2-39:2019-11 (36 4800) |
| Poznámka vo Vestníku: | |
| Predmet normy: | IEC 60601-2-39:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD 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 DIALYSING SOLUTION control system of PD EQUIPMENT using regeneration of DIALYSING SOLUTION or CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION. It does, however, take into consideration the specific safety requirements of such PD EQUIPMENT concerning ... |
| Náhľad normy: | Náhľad normy (PDF) |