Arthrex AR-6529S, Instructions For Use Manual

Page: 33 / 174

INSTRUCTIONS FOR USE
Document Number: D-720763
Page 33
Issue Date: 31 MAR 2020
Version: C 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