List Of Applicable Standards - AMATECH F-70403 Instrucciones De Uso

INSTRUCTIONS FOR USE
5

List of Applicable Standards:

Sl. no
EN 62366-1
1.
EN ISO 14971
2.
EN 1041
3.
EN ISO 15223-1
4.
EN ISO 10993-1
5.
EN ISO 10993-5
6.
ISTA
7.
Document Number: 80028216
Version: A
Standards
Page 14
Description
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
Biological evaluation of medical devices –
Part 5: tests for in vitro cytotoxicity
International Safe Transit Association standards
for package testing
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. D