AMATECH F-NTSHD Instrucciones De Uso página 15

INSTRUCTIONS FOR USE
5. List of Applicable Standards:
Sl. no Standards
EN 62366-1
1.
EN ISO 14971
2.
EN 1041
3.
EN ISO 15223-1
4.
EN ISO 10993-1
5.
IEC 60601-2-46
6.
ISTA
7.
Document Number: D-720545
Version: C
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
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Description
Issue Date: 24 MAR 2020
Ref Blank Template: 80025118 Ver. E