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INSTRUCTIONS FOR USE
5.
List of Applicable Standards:
Sl. no
Standards
1
EN 62366-1
2
EN ISO 14971
3
EN 1041
4
EN ISO 15223-1
5
EN ISO 10993-1
6
EN ISO 10993-5
7
EN ISO 10993-10
8
EN 60601-1
9
IEC 60601-2-46
10
ISTA
Document Number: 80028190
Version: E
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
Biological evaluation of medical devices - Part 5:
tests for in vitro cytotoxicity
Biological evaluation of medical devices - part 10:
tests for irritation and skin sensitization
General requirements for basic safety and essential
performance
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 69
English
Description
Issue Date: 16 MAY 2022
Ref Blank Template: 80025117 Ver. F
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