ISO 18472:2006 pdf download.Sterilization of health care products —Biological and chemical indicators —Test equipment.
4 Performance requirements for resistometers
4.1 Intended use
The resistonieter is intended to be used to expose test samples under stated test conditions, and therefore shall be capable of producing cycle sequences as required for specific test methods, Depending upon the test methods defined in ISO 11138-2. ISO 11138-3, ISO 11138-4 and ISO 11140-1, the resistometer utilized need only verify those limits necessary to characterize the chemical or biological indicators.
NOTE The following specifications define the conditions to be achieved m the vessel in which the sample is to be placed, but the means by which these conditions are to be controlled are not addressed.
4.2 Measurement and control capabilities
The following performance requirements define the measurement and control capabilities for steam, ethylene
oxide, dry heat, and vaporized hydrogen peroxide resistonieters.
4.3 Test methods
The equipment specified In this International Standard shall be used with the detailed test methods given in the appropriate parts of ISO 11138 and ISO 11140.
NOTE The daimed performance tolerances for d’iernical and biological md,cators are based on the specified exposure conditions without allowance for the operational tolerances of the test equipment
4.4 Leak test
4.4.1 With the temperature stabilized and the chamber empty (except for fixed furniture and necessary monitoring sensors) start the test cycle. When the pressure in the chamber has reached or is below the value corresponding to the lowest operating vacuum of the test cycle air removal stages, close all the valves connected to the chamber and stop the vacuum pump. Observe and record the time, i, and the absolute pressure. Pt’ Allow evaporation of condensation in the chamber for 300 S ± lOs and then observe and record the absolute pressure, P2 the chamber and the time, 2’ After a further 600 s ± lOs, again observe and record the absolute pressure. p3. and the time, 13.
4.1 Intended use
The resistonieter is intended to be used to expose test samples under stated test conditions, and therefore shall be capable of producing cycle sequences as required for specific test methods, Depending upon the test methods defined in ISO 11138-2. ISO 11138-3, ISO 11138-4 and ISO 11140-1, the resistometer utilized need only verify those limits necessary to characterize the chemical or biological indicators.
NOTE The following specifications define the conditions to be achieved m the vessel in which the sample is to be placed, but the means by which these conditions are to be controlled are not addressed.
4.2 Measurement and control capabilities
The following performance requirements define the measurement and control capabilities for steam, ethylene
oxide, dry heat, and vaporized hydrogen peroxide resistonieters.
4.3 Test methods
The equipment specified In this International Standard shall be used with the detailed test methods given in the appropriate parts of ISO 11138 and ISO 11140.
NOTE The daimed performance tolerances for d’iernical and biological md,cators are based on the specified exposure conditions without allowance for the operational tolerances of the test equipment
4.4 Leak test
4.4.1 With the temperature stabilized and the chamber empty (except for fixed furniture and necessary monitoring sensors) start the test cycle. When the pressure in the chamber has reached or is below the value corresponding to the lowest operating vacuum of the test cycle air removal stages, close all the valves connected to the chamber and stop the vacuum pump. Observe and record the time, i, and the absolute pressure. Pt’ Allow evaporation of condensation in the chamber for 300 S ± lOs and then observe and record the absolute pressure, P2 the chamber and the time, 2’ After a further 600 s ± lOs, again observe and record the absolute pressure. p3. and the time, 13.
