Résumé
ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
ISO/TR 80002-2:2017 applies to
- software used in the quality management system,
- software used in production and service provision, and
- software used for the monitoring and measurement of requirements.
It does not apply to
- software used as a component, part or accessory of a medical device, or
- software that is itself a medical device.
Prévisualiser
Prévisualiser cette norme sur notre Plateforme de consultation en ligne (OBP)
Informations générales
-
État actuel: PubliéeDate de publication: 2017-06Stade: Norme internationale publiée [60.60]
-
Edition: 1
-
Comité technique :ISO/TC 210
- RSS mises à jour
Cycle de vie
Vous avez une question?
Consulter notre FAQ
Service à la clientèle
+41 22 749 08 88
Horaires d’ouverture:
De lundi à vendredi - 09:00-12:00, 14:00-17:00 (UTC+1)