BRUKSANVISNING
5
Oversikt over anvendbare standarder:
Serienr.
EN 62366-1
1.
EN ISO 14971
2.
EN 1041-1
3.
EN ISO 15223-1
4.
EN ISO 10993-1
5.
ISTA
6.
Document Number: 80028225
Version: B
Standarder
Beskrivelse
Medical devices - Part 1: Application of
usability engineering to medical devices
Medical devices- Application of risk
management to medical devices.
Information supplied by the manufacturer of
medical devices
Medical devices - Symbols to be used with
medical device labels, labelling and
information to be supplied - Part 1: General
requirements
Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk
management process
International Safe Transit Association standards
for package testing
Side 184
Issue Date: 24 MAR 2020
Ref Blank Template: 80025118 Ver. E