List Of Applicable Standards - Hillrom O-ABMT Instrucciones De Uso

INSTRUCTIONS FOR USE

5 List of Applicable Standards:

Sl. no
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: 80028132
Version: B
Standards
Page 17
Description
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
Issue Date: 13 MAR 2020
Ref Blank Template: 80025117 Ver. F