Jetzt auswählen und bestellen
341,60 €
exkl. USt.
Konfigurieren
Norm
ÖVE/ÖNORM EN 60601-2-16
Ausgabedatum: 2016 03 01
Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2012) (english version)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred ...
Weiterlesen
ZURÜCKGEZOGEN
: 2022 05 01
Herausgeber:
Austrian Standards International
Format:
Digital | 76 Seiten
Sprache:
Englisch
Aktuell Gültig:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This International Standard does not take into consideration the DIALYSIS FLUID control system
of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID and CENTRAL DELIVERY
SYSTEMS. It does however take into consideration the specific safety requirements of such
HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.
This International Standard specifies the minimum safety requirements for HAEMODIALYSIS
EQUIPMENT. These devices are intended for use either by medical staff or for use by the
PATIENT or other trained personnel under the supervision of medical expertise.
This International Standard includes all ME EQUIPMENT that is intended to deliver a
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering
from kidney failure.
The particular requirements in this International standard do not apply to:
– EXTRACORPOREAL CIRCUITS;
– DIALYSERS;
– DIALYSIS FLUID CONCENTRATES;
– water treatment equipment;
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
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 standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of IEC 60601-1.
NOTE See also 4.2 of IEC 60601-1:2005.
___________
1 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
OVE EN IEC 60601-2-16
2020 06 01
Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlic...
Norm
OVE EN IEC 60601-2-16
2020 06 01
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential...
Norm
ÖVE/ÖNORM EN 60601-2-16
2016 03 01
Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essenti...
Norm
↖
ÖVE EN 60601-2-16
1998 07 01
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Hämodialyse-...
Technische Regel
ÖVE EN 50072
1993 03 03
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit von Peritoneal-Dialyse-G...
Technische Regel
Norm
ISO 3744:2010
Ausgabedatum :
2010 09 22
Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane
Norm
ISO 8638:2010
Ausgabedatum :
2010 06 28
Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Norm
OVE EN IEC 60601-2-16
Ausgabedatum :
2020 06 01
Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten (IEC 60601-2-16:2018) (deutsche Fassung)
Norm
OVE EN IEC 60601-2-16
Ausgabedatum :
2020 06 01
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) (english version)