Hivatkozási szám

MSZ EN IEC 60601-2-16:2020

Dokumentumazonosító

173761

Cím

Gyógyászati villamos készülékek. 2-16. rész: Hemodialízis-, hemodiafiltrációs és hemofiltrációs készülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-16:2018)

Angol cím

Medical electrical equipment. Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2018)

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 HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. 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 consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS 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 HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location. If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments. The particular requirements in this document do not apply to: – EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [12]2); – DIALYSERS (see ISO 8637-1, [11]); – DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]); – DIALYSIS WATER supply systems (see ISO 23500-2, [16]); – CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]), described as systems for bulk mixing concentrate at a dialysis facility; – equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [8]). 201.1.2 Object Replacement: The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HAEMODIALYSIS EQUIPMENT. 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. IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-11:2015 apply as modified in Clauses 202, 208, 210 and 211. IEC 60601-1-3 and IEC 60601-1-12 do not apply. IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013 does not apply as noted in Clause 209. All other published collateral standards in the IEC 60601-1 series apply as published. Túl hosszú

ICS

11.040.20 Vérátömlesztő, infúziós és injekciós berendezések, eszközök

11.040.25 Fecskendők, tűk és katéterek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-01-01

Forrás

idt EN IEC 60601-2-16:2019; idt IEC 60601-2-16:2018

Előd

MSZ EN 60601-2-16:2015

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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