List Of Applicable Standards - AMATECH F-YFES Instructions D'utilisation

INSTRUCTIONS FOR USE
 Do not use bleach or products that contain bleach to clean the device. Injury or
equipment damage can occur.
 After each use, clean the device with alcohol-based wipes.
 Do not put the device into water. Equipment damage can occur.
 Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean
and disinfect the device.
 Read and follow the manufacturer's recommendation for low-level disinfection.
 Read and follow the cleaning product's instructions. Use caution in areas where
liquid can get into the mechanism.
 Wipe the device with a clean, dry cloth.
 Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS
5

List of Applicable Standards:

Sl.
Standards
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: 80024507
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
Page 19
Description
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E