4
Sterilization
A
ll devices must be processed in the completely open position
(
i.e. flushports, jaws, etc.) to allow sterilant contact of all
surfaces. Note that applicable device disassembly should not
r
equire any mechanical tooling (i.e. screwdriver, pliers etc.)
unless otherwise indicated.
A
ll devices with concave surfaces shall be configured so that
water pooling does not occur.
N
ote: These instruments have not been validated for
sterilization using Ethylene Oxide (EO).
Sterilization for United States Market
PREVACUUM STEAM STERILIZATION CYCLES
Prevacuum Steam Sterilization Cycle (U.S. “FDA
C
ompliant – WRAPPED”)
•
Conditioning Pulses: 3
•
Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Dry Time: 30 minutes
• Sterilization Configuration: FDA Cleared Sterilization Wrap
(
2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
p
olypropylene, muslin)
Prevacuum Steam Sterilization Cycle – Immediate Use
S
team Sterilization (U.S. “FDA Compliant – WRAPPED”)
•
Conditioning Pulses: 3
•
Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Sterilization Configuration: FDA Cleared Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
p
olypropylene, muslin)
N
ote: Devices must be used immediately and cannot be
stored for later use.
I
mmediate Use Steam Sterilization is not recommended as
a routine practice. Refer to ANSI/AAMI ST79 for
requirements on when to perform and how to control
immediate use steam sterilization.
Reference: ANSI/AAMI ST79: (current revision)
Comprehensive guide to steam sterilization and sterility
assurance in health care facilities.
Prevacuum Steam Sterilization Cycle (U.S. “FDA
Compliant WRAPPED Sterilization Tray or Case”)
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Dry Time: 30 minutes in chamber, 15 minutes in-chamber
post sterilization, 60 minutes on drying rack.
• Sterilization Configuration: Sterilization Tray or Case
enclosed in FDA Cleared Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
GRAVITY STEAM STERILIZATION CYCLES
Gravity Steam Sterilization Cycle
(U.S. “FDA Compliant – WRAPPED”)
• Temperature: 132°C (270°F) - 135°C (275°F)
• Exposure Time: 15 – 30 minutes
• Dry Time (non lumens): 30 minutes
• Dry Time (lumens): 45 minutes
• Sterilization Configuration: Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Gravity Steam Sterilization Cycle (U.S. “FDA Compliant –
WRAPPED”) Non lumen devices only
• Temperature: 121°C (250°F)
• Exposure Time: 30 minutes
• Dry Time: 30 minutes
• Sterilization Configuration: Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
36-3430I
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