CareFusion V.Mueller Mode D'emploi page 6

Sterilization for United States Market
STANDARD GRAVITY STEAM STERILIZATION CYCLES
Gravity Steam Sterilization Cycle
(U.S. "FDA Compliant – WRAPPED")
• Temperature: 132°C (270°F)
• Exposure Time: 15 minutes
• Dry Time (non lumens): 30 minutes
• Dry Time (lumens): 45 minutes
• Sterilization Configuration: FDA Cleared 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 lumens
• Temperature: 121°C (250°F)
• Exposure Time: 30 minutes
• Dry Time (non lumens): 30 minutes
• Sterilization Configuration: FDA Cleared Sterilization
Wrap (2 layer-1 ply, or 1 layer -2 ply – examples:
cellulose, polypropylene, muslin)
Sterilization for outside United States Market
STANDARD PREVACUUM 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)
Prevacuum 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,
polypropylene, muslin)
Note: Devices must be used immediately and cannot be
stored for later use.
Immediate 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
control immediate use steam sterilization, please refer to
ANSI/AAMI ST79.
References: ISO 17655-1 (current revision) : Sterilization of
health care products - Moist heat - Part 1: Requirements
for the development, validation and routine control of a
sterilization process for medical devices - ANSI/AAMI ST79
(current revision) : Comprehensive guide to steam
sterilization and sterility assurance in health care facilities
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