Penetration tests according to the ISO 11140

Transcription

1 Space for 3M Montage Penetration tests according to the ISO Josephus Paulus Clemens Maria van Doornmalen Gomez Hoyos

2 Outline Purpose penetration tests ETS Alternatives for original Bowie and Dick test Norms Conclusions 2

3 ETS: State of the art system 3

4 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

5 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)

6 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

7 An example process PASS 7 Chamber temperature Internal temperature T3 Thermal conductivity k3 Theoretical Temperature Chamber pressure Internal temperature T5 Thermal conductivity k5

8 An example process FAIL 8 Chamber temperature Internal temperature T3 Thermal conductivity k3 Theoretical Temperature Chamber pressure Internal temperature T5 Thermal conductivity k5

9 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

10 3M Medical Markets Laboratory Cause Leakage Compressed air in 10 3M All Rights Reserved.

11 State of the art 11

12 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

13 Insufficient deep vacuum Condense front will not disappear 13

14 Slow warming up Pre essure Phase 1: Conditioning Phase 2: Sterilization Phase 3: Drying and pressure equilibration Time 14

15 Examples hollow instruments Lumen 15

16 ISO part 6 ISO part 6 is intended to replace EN With Hollow load, hollow A and helix is meant the same: 16

17 Configuration of instruments Relatively difficult to penetrate Relatively easy to penetrate 17

18 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 19 Medical Markets Laboratory (Europe) Results interpretation I

20 Published 20

21 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