AMATECH BF855, Instructions For Use Manual, Page: 18 / 385

INSTRUCTIONS FOR USE
Document Number: 80028206
Page 18
Issue Date: 18 MAR 2020
Version: A Ref Blank Template: 80025118 Ver. E
5. List of Applicable Standards:
Sl. no Standards Description
1. EN 62366-1
Medical devices - Part 1: Application of
usability engineering to medical devices
2.
EN ISO 14971
Medical devices- Application of risk
management to medical devices.
3.
EN 1041
Information supplied by the manufacturer of
medical devices
4.
EN ISO 15223-1
Medical devices - Symbols to be used with
medical device labels, labelling and
information to be supplied - Part 1: General
requirements
5.
EN ISO 10993-1
Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk
management process
6.
IEC 60601-2-46
Medical electrical equipment - Part 2-46:
Particular requirements for the basic safety
and essential performance of operating tables
7.
ISTA
International Safe Transit Association standards
for package testing