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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
IEC 60601-2-46
7
ISTA
Document Number: 80024545
Version D
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 20
Description
Issue Date: 06 MAR 2020
Ref Blank Template: Ver. F
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