HF-GB-17664, Rev. D | Page 4 / 8 Status: 07/2023
The application of dry heat sterilization is the responsibility of the user. For some products the dry heat sterilization procedure has been explicitly excluded (Please see 9.0 Special Procedures section). 5.1 Steam Sterilization
For sterilizing, please remember the following: -
maximum sterilization temperature of 138 °C (280 °F) Minimum exposure time to sterilization temperature: - 20 minutes at 121 °C (250 °F) or - 5 minutes at 132 °C (270 °F)/ - 4 minutes at 134 °C (273 °F)
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- The manufacturer’s instructions with respect to routine inspection and the regular maintenance of the Sterilizer must be observed. - The sterilizer must be maintained per manufacturer’s recommendation. - Only low contaminated and deionized water (i.e. aqua purificata) should be used. - The sterilized items have to be completely dried after sterilization and before handling. Sterilizers with an automatic drying program are recommended.
STERILIZATION PROCEDURE: Use properly installed and validated sterilizers, following instructions of the manufacturer. Load sterilizer as recommended by the manufacturer. Run validated program.
The fundamental suitability of the instruments for an effective sterilization was demonstrated by an independent accredited test laboratory under the following conditions:
Sterilization Method
Pre-vacuum Mode
Sterilizer
W & H Lisa MB 17 Steam Sterilizer
Sterilization Temperature
134 °C (273°F)
Pre-Vacuum Phases
3
Holding (full cycle)
4 minutes
Drying Time
30 minutes*
Validation Report
Project Numbers: 25517-1; 25517-2 Validation of a Sterilization Process using Steam Sterilization in Pre-vacuum Mode Method MD 4.0: Sterilization validation of medical products with moist heat
Project Numbers: 10918-1; 10918-2 Determination of Residual Moisture after Sterilization using Steam Sterilization in Pre-vacuum Mode
The responsibility for reprocessing of Hu-Friedy instruments according to parameters which are not specified in this document lies with the customer.
6.0 Transport and Storage of Reprocessed Instruments Please store the instruments after sterilization in a dry and dust free place.
Sterilization can only be maintained, if the instruments remain packaged or wrapped - impermeable to micro-organisms - following validated standards. The status of the sterilization has to be clearly indicated on the wrapped packages or the containers. In case the reprocessed instrument is transported, make sure to use air-conditioned vehicles in order to avoid condensate formation. For safety reasons, keep sterile and non-sterile instruments strictly apart.
7.0 Material resistance We recommend not to use detergents such as strong alkalines (> pH 9), strong acids (< pH 4) phenols or iodophors, interhalogenic agents/halogenic hydrocarbons/iodophors, strong oxidizing agents/peroxides and organic solvents.
Do not clean any instruments, sterilization trays or sterilization containers using metal brushes or steel wool!
Do not expose any instruments, cassettes, trays or sterilization containers to temperatures higher than 141 °C (286 °F)! Exposure to higher temperatures is the responsibility of the user.
Please also consider the information under the 9.0 Special Procedures section.
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