Norm

NEN-EN-IEC 60601-2-49:2015 en

Medische elektrische toestellen - Deel 2-49: Bijzondere eisen voor de veiligheid van multifunctionele patientbewakingsapparatuur

226,42

Over deze norm

Status Definitief
Aantal pagina's 56
Commissie Medische elektrische toestellen
Gepubliceerd op 01-10-2015
Taal Engels
NEN-EN-IEC 60601-2-49 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use. The scope of this standard is restricted to ME EQUIPMENT intended for connection to a single PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART. This standard does not specify requirements for individual monitoring functions such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING EQUIPMENT, since such equipment has a broader INTENDED USE than this stand-alone ME EQUIPMENT.

Details

ICS-code 11.040.55
Nederlandse titel Medische elektrische toestellen - Deel 2-49: Bijzondere eisen voor de veiligheid van multifunctionele patientbewakingsapparatuur
Engelse titel Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
Vervangt

Winkelwagen

Subtotaal:

Ga naar winkelwagen