Stryker F-SFHPBER, Instructions For Use Manual

Page: 18 / 389

INSTRUCTIONS FOR USE
Document Number: 80028212
Page 18
Issue Date: 25 MAR 2020
Version: A Ref Blank Template: 80025118 Ver. E
5 List of Applicable Standards:
Sl. no Standards Description
1.
EN 62366-1
Medical devices - Part 1: Application of usability
engineering to medical devices
2.
EN ISO 14971
Medical devices- Application of risk management
to medical devices.
3.
EN 1041
Information supplied by the manufacturer of
medical devices
4.
EN ISO 15223-1
Medical devices - Symbols to be used with
medical device labels, labelling and information
to be supplied - Part 1: General requirements
5.
EN ISO 10993-1
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process
6.
IEC 60601-2-46
Medical electrical equipment - Part 2-46:
Particular requirements for the basic safety and
essential performance of operating tables
7.
ISTA
International Safe Transit Association standards for
package testing