List Of Applicable Standards - Hillrom Allen A-93005 Manual Del Usuario

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: 80028199
Version: B
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: 31 MAR 2020
Ref Blank Template: 80025117 Ver. F