Norm

NEN-EN-IEC 60601-2-23:2015 en

Medische elektrische toestellen - Deel 2-23: Bijzondere eisen voor de veiligheid en essentiƫle eigenschappen voor bewaking van deeldruk via de huid

208,31

Over deze norm

Status Definitief
Aantal pagina's 50
Commissie Medische elektrische toestellen
Gepubliceerd op 01-11-2015
Taal Engels
NEN-EN-IEC 60601-2-23 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter referred to as ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a system. This standard applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). 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 11.040.55
Nederlandse titel Medische elektrische toestellen - Deel 2-23: Bijzondere eisen voor de veiligheid en essentiƫle eigenschappen voor bewaking van deeldruk via de huid
Engelse titel Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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