List Of Applicable Standards - Stryker F-SFHPBER Manual De Instrucciones

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: 80028212
Version: A
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 18
Description
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. E