Hillrom A-70117 Instrucciones De Uso página 17

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: 80028173
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
Page 17
Description
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F