Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

Informácie o norme:

Označenie normy: IEC/TR 62366-2-ed.1.0
Dátum vydania normy: 27.4.2016
Počet strán: 102
Približná hmotnosť: 337 g (0.74 libier)
Krajina: Medzinárodná technická norma
Kategória: Technické normy IEC

Anotácia textu normy IEC/TR 62366-2-ed.1.0 :

IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information. This publication is to be read in conjunction with IEC 62366-1:2015.