Norm

NEN-ISO 14708-1:2014 en

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

161,21

Over deze norm

Status Definitief
Aantal pagina's 57
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-2014
Taal Engels
NEN-ISO 14708-1 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This Part 1 of ISO 14708 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 1 of ISO 14708 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.

Details

ICS-code 11.040.40
Nederlandse titel Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 1: Algemene eisen voor veiligheid, markering en te verstrekken informatie door de fabrikant
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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