Norm

IEC 60601-2-31:2008+A1:2011 en

Medische elektrische toestellen - Deel 2-31: Bijzondere eisen voor de veiligheid en essenti?le prestaties van uitwendige hartritmeregelaars met interne voedingsbron

274,20

Over deze norm

Status Definitief
Aantal pagina's 40
Commissie Medische elektrische toestellen
Gepubliceerd op 01-09-2011
Taal Engels
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS as defined in 201.3.106. HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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. This standard does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT.

Details

ICS-code 11.040.01
Nederlandse titel Medische elektrische toestellen - Deel 2-31: Bijzondere eisen voor de veiligheid en essenti?le prestaties van uitwendige hartritmeregelaars met interne voedingsbron
Engelse titel Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Vervangt

Winkelwagen

Subtotaal:

Ga naar winkelwagen