acumed Anatomic Radial Head System Handbuch Seite 8

US
Steam Sterilizer Parameters
Anatomic Radial Head System
Storage Case Part Numbers:
Gravity Displacement Steam Sterilization:
Condition:
Exposure Temperature:
Exposure Time:
Dry Time:
Pre-Vacuum Steam Sterilization:
Condition:
Preconditioning Vacuum Pulses:
Exposure Temperature:
Exposure Time:
Dry Time:
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.
* US customers shall use an FDA-cleared sterilization wrap.
PKGI-42-T Effective 08-2019
1
Base: TR-0003
Case Lid: TR-0002
Wrapped
270°F (132°C)
35 minutes
50 minutes
Wrapped*
3
270°F (132°C)
25 minutes
50 minutes
Steam Sterilizer Parameters
Anatomic Radial Head Solutions
Storage Case Part Numbers:
Gravity Displacement Steam Sterilization:
NOT RECOMMENDED
Pre-Vacuum Steam Sterilization:
Condition:
Preconditioning Vacuum Pulses:
Exposure Temperature:
Exposure Time:
Dry Time:
2
Cooling Time
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 following dry time
and prior to handling. This interval is included for safe handling
and the prevention of contamination; see ANSI/AAMI ST79:2010
Section 8.8.1.
* US customers shall use an FDA-cleared sterilization wrap.
English – US / PAGE 8
1
Base: 80-2000
Case Lid: 80-2001
Wrapped*
4
270°F (132°C)
4 minutes
30 minutes
30 minutes