Bioburden testing
Bioburden testing is done to determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
Optional Tests for Bioburden testing
Bioburden, recovery qualification ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
Bioburden, inoculate product method ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
Bioburden, exhaustive rinse method ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden Pooling Fee (plus cost of test) ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
Bioburden, aerobic & anaerobic bacteria, spores & fungi ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, aerobic bacteria, spores & fungi ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, aerobic, anaerobic bacteria & fungi ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, aerobic bacteria & spores ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, aerobic bacteria & fungi ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, aerobic & anaerobic bacteria ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, spores only ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, fungi only ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
Bioburden, anaerobic bacteria only ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
Bioburden, aerobic bacteria only ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
To determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
To act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall.
To calculate the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
