acumed Anatomic Radial Head System Handbuch Seite 24

EN
Anatomic Radial Head System
Storage Case Part Numbers:
Gravity Displacement Steam Sterilisation:
Condition:
Exposure Temperature:
Exposure Time:
Drying time:
Pre-vacuum Steam Sterilisation:
Condition:
Preconditioning Vacuum Pulses:
Exposure Temperature:
Exposure Time:
Drying time:
Steam Steriliser Parameters
1
Values in this table reflect the minimum parameters validated to
achieve the required sterility assurance level (SAL) for a fully-
loaded tray with all parts placed appropriately.
PKGI-42-T Effective 08-2019
Base: TR-0003
Case Lid: TR-0002
Wrapped
132°C (270°F)
35 minutes
50 minutes
Wrapped
3
132°C (270°F)
25 minutes
50 minutes
1
Anatomic Radial Head Solutions
Storage Case Part Numbers:
Gravity Displacement Steam Sterilisation:
NOT RECOMMENDED
Pre-vacuum Steam Sterilisation:
Condition:
Preconditioning Vacuum Pulses:
Exposure Temperature:
Exposure Time:
Drying time:
2
Cooling Time
Steam Steriliser Parameters
1
Values in this table reflect the minimum parameters validated to
achieve the required sterility assurance level (SAL) for a fully-
loaded tray with all parts placed appropriately.
2
Cooling time describes the validated interval between drying time
and handling. This interval is included for safe handling and for
the prevention of contamination; see ANSI/AAMI ST79:2010
Section 8.8.1.
English– EN/ PAGE 24
Base: 80-2000
Case Lid: 80-2001
Wrapped
4
132°C (270°F)
4 minutes
30 minutes
30 minutes
1