Space for 3M Montage Penetration tests according to the ISO 11140 Josephus Paulus Clemens Maria van Doornmalen Gomez Hoyos
Outline Purpose penetration tests ETS Alternatives for original Bowie and Dick test Norms Conclusions 2
ETS: State of the art system 3
Only Medical convection Markets Laboratory and (Europe) tube in sterilizer chamber Sterilizer chamber Compressing Process and decompressing the gas Press sure Convection can be imposed Time Steam inlet Pumping of gas mix Interface between air and steam Act like a piston in a cylinder 4
None Condensable gases in steam (State of the art) More important: Accumulation of NCGs NCGs cannot condense NCGs No sterilization cannot flow against conditions the stream Wall temperature e ( C) mperature Steam curve Te Air curve Animation steam flow stopped For clarity 5 Represents NCG Time (s)
Example: ETS Liquid id Crystal Internal Polymer tube Temperature Sensor T 3 Aluminium Challenge Loads Internal Temperature Sensor T 5 Stainless Steel Housing External Temperature Sensor T ext Thermal Insulation Pressure Sensor 6
An example process PASS 7 Chamber temperature Internal temperature T3 Thermal conductivity k3 Theoretical Temperature Chamber pressure Internal temperature T5 Thermal conductivity k5
An example process FAIL 8 Chamber temperature Internal temperature T3 Thermal conductivity k3 Theoretical Temperature Chamber pressure Internal temperature T5 Thermal conductivity k5
Examples combined Steam sterilization conditions NO steam sterilization conditions 9 Chamber temperature Internal temperature T3 Thermal conductivity k3 Theoretical Temperature Chamber pressure Internal temperature T5 Thermal conductivity k5
3M Medical Markets Laboratory Cause Leakage Compressed air in 10 3M 2007. All Rights Reserved.
State of the art 11
Effect NCG s Steam Injection (Steam with NCG s) O 2, N 2, CO 2, H 2 O Steam injection, pressure increasing Condensation of water 12
Insufficient deep vacuum Condense front will not disappear 13
Slow warming up Pre essure Phase 1: Conditioning Phase 2: Sterilization Phase 3: Drying and pressure equilibration Time 14
Examples hollow instruments Lumen 15
ISO 11140 part 6 ISO 11140 part 6 is intended to replace EN 867-5 With Hollow load, hollow A and helix is meant the same: 16
Configuration of instruments Relatively difficult to penetrate Relatively easy to penetrate 17
Process Pressure CP Come-up 4 pulses : CP vac = 300, 320, 350, 370, 400 mbar 3 pulses : CP steam = 950mbar Come-up : CP = 3100 mbar Target P/ t: 400mbar/min CP Steam CP vac Time 18
19 Medical Markets Laboratory (Europe) Results interpretation I
Published 20
Current situation and conclusions ETS is state of the art steam penetration test More detailed information Trouble Digital logbook B&D tests are fulfilling the minimum requirements Can be tricked Helix system are not steam penetration tests Introducing false sense of security 21