acumed Anatomic Radial Head System Handbuch Seite 9

US
Steam Sterilizer Parameters
Anatomic Radial Head Solutions 2
Storage Case Part Numbers:
Gravity Displacement Steam Sterilization:
NOT RECOMMENDED
Pre-Vacuum Steam Sterilization:
Condition:
Exposure Temperature:
Exposure Time:
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.
PKGI-42-T Effective 08-2019
1
Base: 80-3640, 80-3692, or 80-3693
Case Lid: 80-3641
Wrapped*
270°F (132°C)
4 minutes
273°F (134°C)
3 minutes
30 minutes
30 minutes
English – US / PAGE 9