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Unwrapped items ("flash sterilization"):
Temperature
Exposure time
Here are some recommended guidelines for steam sterilization:
•
Never sterilize the accessories using dry air sterilization.
•
Handle the accessories gently. They are precision instruments.
•
During the sterilization process, do not allow any of the accessories to touch any other
items.
•
Use only demineralized water for sterilization.
Ethylene Oxide Sterilization Parameters
100% EtO cycles
Concentration of EtO :
Temperature
Exposure time
Relative humidity
Following EtO sterilization, the illumination accessories must be aerated to remove any residual
EtO gas. The aeration time must be sufficient to reduce the residues below the maximum levels as
proposed in the "USA Federal Register", Volume 43, No. 122, June 23, 1978, pp. 27482-3.
Caution !!!
The effectiveness of sterilization methods other than that specified above is
unknown and should be validated by the user.
Warning!!!
Remember that the suggested parameters are just guidelines. They represent
industry standards, and should be capable of producing a sterile device. Because
of variations in sterilization equipment and device bioburden, D.O.R.C.
International is not able to provide more specific cycle parameters. It is the
responsibility of each user to perform validation and verification of the sterilization
equipment and cycle to ensure adequate sterility assurance level for these products.
References:
•
"ANSI/AAMI ST41 Good Hospital Practice, Ethylene Oxide Sterilization and
Sterility Assurance."
•
"AORN Recommended Practices for Steam and Ethylene Oxide Sterilization."
•
"AAMI Good Hospital Practice: Steam Sterilization and Sterility Assurance",
(1992B, 1993b, 1994b).
•
EN550, "Sterilization of Medical Devices, Validation and routine control of
Ethylene Oxide Sterilization."
•
EN554, "Sterilization of Medical Devices, Validation and routine Control of
Sterilization by Moist Heat."
30300300C
D.O.R.C. MICRO DIATHERMY SYSTEM
:
270EF (132EC)
:
4 minutes
850 ±50 mg/l
:
99EF to 117EF (37EC to 47EC)
:
3 to 4 hours
:
70%
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