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  6. 3M™ Attest™ Vaporized Hydrogen Peroxide (H₂O₂) Type 4 Tri-Metric Chemical Indicators

3M™ Attest™ Vaporized Hydrogen Peroxide (H₂O₂) Type 4 Tri-Metric Chemical Indicators

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First chemical indicator strip to be classified by the FDA as a multi-variable indicator for chemical vapor sterilization

Monitors 3 critical variables – exposure time, temperature and VH2O2 concentration

Detects failed VH2O2 sterilization cycles more accurately than any other CI tested* *Competitive Type 1 and Type 4 VH2O2 Cis

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Details

Highlights
  • First chemical indicator strip to be classified by the FDA as a multi-variable indicator for chemical vapor sterilization
  • Monitors 3 critical variables – exposure time, temperature and VH2O2 concentration
  • Detects failed VH2O2 sterilization cycles more accurately than any other CI tested* *Competitive Type 1 and Type 4 VH2O2 Cis
  • Easy-to-read “ACCEPT” and “REJECT” zones
  • The most color-stable of all VH2O2 CIs tested – won’t changecolor before sterilization under ambient light*
  • Easy-to-read “accept” and "reject" zones
  • *Competitive Type 1 and Type 4 VH2O2 CIs

The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E verifies that the stated values for the three (3) critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide (VH2O2) have been achieved within a package or containment device (i.e., wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber. Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the indicator strip is visible through a window with marked “REJECT” and “ACCEPT” zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.

As a Type 4 Chemical Indicator, the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E monitors sterilization conditions inside medical instrument packs in sterilizers and is compliant with ISO 11140-1:2014. It is also the first chemical indicator classified by the FDA as a multi-variable indicator for chemical vapor sterilization.

The color-coded indicator strip starts off blue and gradually turns pink when exposed to vaporized hydrogen peroxide. Easy-to-read “REJECT” and “ACCEPT” zones assist the user with the interpretation of the device. The proprietary protective film helps to prevent the ink from smearing on surgical instruments and other surfaces. This innovative technology independently verifies that the stated values of exposure time, temperature and vaporized hydrogen peroxide concentration have been met.

Suggested applications
  • For use as an internal pack monitor in vaporized hydrogen peroxide sterilizers. For more details, review the Instructions for Use

Specifications

Resources

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