Hivatkozási szám

MSZ EN IEC 60601-2-39:2020

Dokumentumazonosító

173762

Cím

Gyógyászati villamos készülékek. 2-39. rész: Peritoneális dializálókészülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-39:2018)

Angol cím

Medical electrical equipment. Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2018)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 Scope Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, 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. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury or disability. These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING SOLUTION CIRCUIT. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PD EQUIPMENT as defined in 201.3.208. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. Túl hosszú

ICS

11.040.99 Egyéb orvostechnikai berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-01-01

Forrás

idt IEC 60601-2-39:2018; idt EN IEC 60601-2-39:2019

Előd

MSZ EN 60601-2-39:2008, MSZ EN 60601-2-39:2008/A11:2012

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

kapható formátuma

Papír ,
PDF (letöltés) (a fájl mérete: 746542) ,

oldalszáma

32 oldal; P kategória

ára

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Papír formátum esetén (5% Áfával): 15775 Ft
PDF (letöltés) formátum esetén (27% Áfával): 15900 Ft