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INSTRUCTIONS FOR USE
5
List of Applicable Standards:
Sl. no
1
EN 62366-1
2
EN ISO 14971
3
EN 1041
4
ISO 15223-1
5
EN ISO 10993-1
6
IEC 60601-2-46
7
ISTA
Document Number: 80028169
Version C
Standards
Page 37
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: Requirements for the basic safety
and essential performance of operating tables
International Safe Transit Association standards
for package testing
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F
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