List Of Applicable Standards - Arthrex AR-1650S Instrucciones De Uso

INSTRUCTIONS FOR USE
Validated Washer Parameters for Arm Sleeve Connector and Lateral Traction
Sleeve:
Phase
Pre-Wash 1
Wash 1
Rinse 1
Rinse 2
Thermal
Disinfection
Drying
Disposables:
Dispose of materials appropriately according to facility requirements.
•
Warning: DO NOT reuse disposables.
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: D-720764
Version: C
Recirculation
Temperature
time (minutes)
3:00 Cold tap water
10:00
3:00
3:00
5:00
6:00
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 38
Detergent type and
Neodisher® Mediclean
65.5°C
Forte ¼ oz/gallon
50°C
50°C
90°C
115°C
Description
Ref Blank Template: 80025118 Ver. E
Concentration
N/A
N/A
N/A
N/A
N/A
Issue Date: 27 MAR 2020