Internal controls

Type 4, 5 and 6 chemical indicators are used to be placed in strategic positions within the packages of medical devices for sterilization.

Type 4. Multi-variable indicators

Multiparametric indicators, designed to react with two or more critical parameters of the sterilization process. They indicate the completion of the Stated Values (SV) of the reference parameters of the sterilization process. The manufacturer indicates the conditions in which these chemical indicators reach the final turning point.  

 

Type 5. Integrator indicators

They are designed to react to all critical variables. The values for the turning point/Stated Values (SV) are at least equivalent or exceed the performance requirements of a biological indicator for the specific sterilization technology.

 

Type 6. Emulator indicators

They are designed to respond to all process critical variables, emulating the times and temperatures of sterilization plateau of the steam sterilizers. The tolerances defined for these chemical indicators are the strictest amongst the various classes. These indicators offer the highest assurance level to demonstrate that they have met the critical parameters of a specified cycle.

 

 

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