Norm

NEN-EN-IEC 60601-2-39:2008 en

Medische elektrische toestellen - Deel 2-39: Bijzondere eisen voor de algemene veiligheid en essentiƫle prestaties van peritoneale-dialysetoestellen

Volledig inclusief:

72,46

Over deze norm

Status Definitief
Aantal pagina's 34
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2008
Taal Engels
This International Standard 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

Details

ICS-code 11.040.60
11.040.99
Nederlandse titel Medische elektrische toestellen - Deel 2-39: Bijzondere eisen voor de algemene veiligheid en essentiƫle prestaties van peritoneale-dialysetoestellen
Engelse titel Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Vervangt
Vervangen door
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

Winkelwagen

Subtotaal:

Ga naar winkelwagen