List Of Applicable Standards - AMATECH BF855 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.
IEC 60601-2-46
6.
ISTA
7.
Document Number: 80024526
Version: B
Standards 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
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 19
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E