Norm

IEC 60601-2-39:2018-RL en

Medische elektrische toestellen - Deel 2-39: Bijzondere eisen voor de algemene veiligheid en essentiƫle prestaties van peritoneale-dialysetoestellen (Redline versie met track changes)

185,29 224,20 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 86
Commissie Medische elektrische toestellen
Gepubliceerd op 01-04-2018
Taal Engels
IEC 60601-2-39 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. - THIS REDLINE VERSION PROVIDES YOU WITH QUICK AND EASY WAY TO COMPARE ALL THE CHANGES BETWEEN THIS STANDARD AND ITS PREVIOUS EDITION. A VERTICAL BAR APPEARS IN THE MARGIN WHEREVER A CHANGE HAS BEEN MADE. ADDITIONS AND DELETIONS ARE DISPLAYED IN RED, WITH DELETIONS BEING STRUCK THROUGH.

Details

ICS-code 11.040.99
Nederlandse titel Medische elektrische toestellen - Deel 2-39: Bijzondere eisen voor de algemene veiligheid en essentiƫle prestaties van peritoneale-dialysetoestellen (Redline versie met track changes)
Engelse titel Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (Redline version with track changes)

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