CareFusion V.Mueller - Page 6

Sterilization for outside United States Market
P
REVACUUM STEAM STERILIZATION CYCLES
Prevacuum Steam Sterilization Cycle (Outside U.S. Market)
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F) - 135°C (275°F)
•
Exposure Time: 3-18 minutes
•
Dry Time: 30 minutes
•
Sterilization Configuration: Sterilization Wrap
(
2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
P
revacuum Steam Sterilization Cycle – Immediate Use
Steam Sterilization (Outside U.S. Market)
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F) - 135°C (275°F)
• Exposure Time: 3-18 minutes
• Sterilization Configuration: 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
s
tored for later use.
I
mmediate Use Steam sterilization is not recommended as
a routine practice. In order to control steam sterilization
please refer to ISO 17665-1 or ANSI/AAMI ST79. To
c
ontrol immediate use steam sterilization, please refer to
A
NSI/AAMI ST79.
References ISO 17655-1 (current revision) : Sterilization of
health care products - Moist heat - Part 1: Requirements
f
or the development, validation and routine control of a
s
terilization process for medical devices - ANSI/AAMI ST79
(current revision): Comprehensive guide to steam
sterilization and sterility assurance in health care facilities.
Prevacuum Steam Sterilization Cycle
(Outside U.S. Market “WRAPPED Sterilization Tray or
C
ase”)
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F) - 135°C (275°F)
• Exposure Time: 3-18 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 Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
GRAVITY STEAM STERILIZATION CYCLES
Gravity Steam Sterilization Cycle (Outside U.S. Market)
• 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 (Outside U.S. Market)
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)
5
Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
36-3430I