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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:

ANSI/AANI ST79.2006

DIN 285:2009

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:

Ethylene oxide

Ozone

Bleach

Glutaraldehyde and formaldehyde

Phthalaldehyde

Hydrogen Peroxide

Dry sterilization process

Peracetic acid

H2O/Alcohol Mix.

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.