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

Informace o normě:

Označení normy: IEC/TR 62366-2-ed.1.0
Datum vydání normy: 27.4.2016
Počet stran: 102
Přibližná hmotnost: 337 g (0.74 liber)
Země: Mezinárodní technická norma
Kategorie: Technické normy IEC

Anotace 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.