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STERILIZATION OF STERITOOL STAINLESS HAND TOOLS – JANURARY 2010
To Whom it Concerns:
This is to certify that all Steritool stainless steel hand tools can be steam sterilized/autoclaved to the following standards, through thousands of cycles:
DIN 58950 Pharma
HTM / HTM 2030 UK Sterilization Standards
AANI/ISO 11345-R-8/93 Industry Standard for Moist Heat Sterilization
FDA Reg. 21 CFR, Part 11 cGMP requirements.
For other methods of sterilization it is prudent and necessary to carry out a test using one hand tool item to evaluate the effect on the tool and the sterilization equipment. Be especially careful with tools that have Zytel handles and tools that utilize Type 420/430/440 Stainless Steel.
Examples of types of sterilization include the following:
Glutaraldehyde and formaldehyde
Dry sterilization process
Follow industry standards for times and temperatures. Hand tools are sterilized using guidelines that are used for most critical environment instruments made from similar alloy.
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