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MSZ EN IEC 60601-2-39:2025

Dokumentumazonosító

185869

Cím

Gyógyászati villamos készülékek. 2-39. rész: Peritoneális dializálókészülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-39:2024)

Angol cím

Medical electrical equipment. Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2024)

Alkalmazási terület

Replacement: This part of IEC 60601 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 electrical safety and PATIENT safety. This document specifies the minimum safety requirements for PD EQUIPMENT. These PD EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision. This document includes all ME EQUIPMENT that is intended to deliver a PERITONEAL DIALYSIS treatment to a PATIENT, independent of the treatment duration and location. These particular requirements do not apply to: – PRE-MANUFACTURED DIALYSING SOLUTION bags, – DIALYSING SOLUTION CIRCUITS, – DIALYSING SOLUTION CONCENTRATE, – DIALYSIS WATER supply systems (see ISO 23500-2 [1])1, – CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION CONCENTRATES, described as systems for bulk mixing concentrate at a dialysis facility, – equipment used to perform HAEMODIALYSIS (see IEC 60601-2-16 [2]).

ICS

11.040.99 Egyéb orvostechnikai berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2025-06-01

Forrás

idt EN IEC 60601-2-39:2025; idt IEC 60601-2-39:2024

Előd

MSZ EN IEC 60601-2-39:2020

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

kapható formátuma

Papír ,
PDF (letöltés) (a fájl mérete: 1815728) ,

oldalszáma

60 oldal; U kategória

ára

Nettó: 20030 Ft
Bruttó:
Papír formátum esetén (20% nyomdai költséggel, 5% Áfával): 25238 Ft
PDF (letöltés) formátum esetén ( 27% Áfával): 25438 Ft