List Of Applicable Standards - AMATECH F-91501 Instrucciones De Uso

INSTRUCTIONS FOR USE
5

List of Applicable Standards:

Sl. no Standards
EN 62366-1
1.
EN ISO 14971
2.
EN 1041
3.
EN ISO 15223-1
4.
EN ISO 10993-1
5.
IEC 60601-2-46
6.
ISTA
7.
Document Number:80028269
Version: C
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
Medical electrical equipment - Part 2-46: Particular
requirements for the basic safety and essential performance
of operating tables
International Safe Transit Association standards for package
testing
Page 30
Description
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E