Norm

NEN-EN 45502-1:2015 en

Actieve implanteerbare medische hulpmiddelen - Deel 1: Algemene eisen voor veiligheid, aanduiding en door de fabrikant te verstrekken informatie

16,10

Over deze norm

Status Definitief
Aantal pagina's 2
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN 45502-1 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This part of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.

Details

ICS-code 11.040.01
Nederlandse titel Actieve implanteerbare medische hulpmiddelen - Deel 1: Algemene eisen voor veiligheid, aanduiding en door de fabrikant te verstrekken informatie
Engelse titel Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
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