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Saniclave RS-SC-200
Biological Indicators
Microbial devices such as biological indicators (BI) are designed to accompany a load
to be sterilized. When a BI shows failure, the load must not be considered sterile.
Note: Wrapping, packing and loading improperly may result in failures. In addition, the
failure may be a result of sterilizer malfunction. Check load configuration and verify
that it is in accordance with the manufacturer's instructions. Also, check the BI's
instructions for proper use, storage and disposal. Only BI's that are cleared by the
FDA and labeled for use with the same physical parameters (of exposure time and
temperature) of the Saniclave 200 shall be used to monitor sterility of loads
processed in Saniclave 200.
Class 5 Integrators
A Class 5 integrator are a type of chemical indicator. It does not contain microbial
organisms. A Class 5 Integrator monitors the time, temperature and pressure. These
single use devices are calibrated to confirm that parameters have been met. Only use
FDA cleared integrators that are validated for 121C for 30 minutes. Follow
manufacturer's recommendations."
Use an FDA approved biological indicator (BI) weekly to confirm sterility and
STEAMPlus Class 5 integrators with each load. Follow the BI manufacturer's
instructions. Revolutionary Science recommends the use of biological indicators and
class 5 integrators manufactured by SPS Medical.
SPSmedical Supply Corp. 6789 W Henrietta Road Rush, NY 14543 USA
(800) 722-1529
www.spsmedical.com
R E V O L U T I O N A R Y S C I E N C E
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