
The 3M? Attest? 1262-S Biological Indicator is a reliable and convenient biological indicator forvalidating and monitoring industrial and pharmaceutical steam sterilization processes.
The Attest 1262-S may be used as a component of the quality system for a steam sterilization process that ensures that medical devices or biologics are processed
per the manufacturer’s specifications and comply with the requirements of national and international sterilization standards.
The Attest 1262-S should be used with appropriate testing, verification, and documentation by the end user.
The Attest 1262-S is a self-contained biological indicator. This design reduces testing time and eliminates the potential for cross-contamination associated with the culturing of conventional spore strips. The Attest 1262-S design is comprised of a paper carrier inoculated with a standardized population of Geobacillus stearothermophilus ATCC?
7953 spores, a glass ampoule containing recovery medium which includes a pH indicator dye, a plastic cap with filter,and a plastic vial. (See Figure 1) The biological indicator has
a chemical process indicator on the label that will change from rose to brown upon exposure to the steam sterilization process. The recovery media will produce a pH color changefrom purple to yellow if viable spores are present and incubation conditions are correct.
The Attest 1262-S is recommended for 132oC (270oF) vacuum-assisted and 121oC (250oF) gravity steam sterilization processes. The Attest 1262-S could also be used to monitorother steam sterilization processes, such as 134oC (273oF), with appropriate testing and validation by the end user. The suitability of the Attest 1262-S for monitoring any steam sterilization process must be verified and documented by the
end user.
Population Specification
3M Attest 1262-S 1.0 x 10^6 – 9.9 x 10^6 cfu/strip
ISO 11138-3:2006 Moist heat BIs 1.0 x 10^5 cfu/strip minimum