Technical Information
0.0 General
0.1 Validation
025 Information about the validation of sterilization processes.pdf (105.6 KiB)- 096 Routine monitoring according to EN ISO 17665-1.pdf (138.7 KiB)
- 100 PCDs are required in the validation standard EN ISO 17665-1.pdf (63.5 KiB)
- 160 Direct inoculation.pdf (121.5 KiB)
- 168 Validation procedure for gke BMS.pdf (277.6 KiB)
- 170 Reprocessing of medical devices in exceptional situations.pdf (257.4 KiB)
- 175 According to the validation standard, test devices (PCD) must have a greater penetration challenge than the load.pdf (85.0 KiB)
0.2 Standards and laws
- 013 Classification of gke indicator systems.pdf (46.0 KiB)
- 053 Labeling of gke indicators.pdf (94.5 KiB)
- 085 General Information about EN and ISO Standards.pdf (17.1 KiB)
- 086 Does it make sense that a PCD can increase the resistance of a BI.pdf (64.0 KiB)
- 134 Safety datasheet for gke PCDs not necessary.pdf (68.4 KiB)
- 174 Are BI and CI medical devices in Europe.pdf (90.8 KiB)
0.3 PCDs
- 018 Durability of Helix-PCDs.pdf (91.6 KiB)
- 028 Comparison of plastic and metal PCDs.pdf (45.5 KiB)
- 039 Use of chemical indicators of third parties with the gke PCDs.pdf (64.7 KiB)
- 048 Where to place BDS and BMS systems in chamber.pdf (95.2 KiB)
- 053 Labeling of gke indicators.pdf (94.5 KiB)
- 070 Are there PCDs suitable for certain sterilizers.pdf (19.1 KiB)
- 072 BD-Test in small sterilizers.pdf (72.6 KiB)
- 076 Influence of indicator capsule construction on the sensitivity of Helix-PCDs.pdf (69.8 KiB)
- 079 Which chemical indicators should be used in a PCD system.pdf (100.2 KiB)
- 080 The gke BDS-Test replaces the BD cotton pack and the hollow load test.pdf (107.5 KiB)
- 088 Design of Compact-PCDs to check the efficacy of sterilization processes.pdf (96.8 KiB)
- 093 DIN 58921 MDS.pdf (112.9 KiB)
- 097 Material Characteristics of PCDs.pdf (94.7 KiB)
- 099 Screw caps and O-rings for Compact-PCDs.pdf (46.6 KiB)
- 102 Reasons for the melting of Compact-PCDs.pdf (46.3 KiB)
- 106 Durability of Compact-PCDs to simulate BD test, type test and batch monitoring tests.pdf (16.1 KiB)
- 113 Suitability of PCDs for SCBIs.pdf (257.6 KiB)
- 128 Indicator capsule volumes of PCDs.pdf (159.9 KiB)
- 129 Advantage using PCDs to monitor steam sterilization processes.pdf (45.8 KiB)
- 141 Use of PCD systems.pdf (99.7 KiB)
- 147 PCD Functionality Test.pdf (89.1 KiB)
0.4 Routine monitoring
1.1 Steam
- 036 Colour change after sterilization war aborted.pdf (245.9 KiB)
- 055 Changes of EN 285 for large sterilizers.pdf (98.5 KiB)
- 081 Incorrect Colour Change of Process Indicators.pdf (18.6 KiB)
- 082 Effects of non-demineralized feeding water for steam generation.pdf (12.0 KiB)
- 084 Application Limitations of NCG Detectors.pdf (81.9 KiB)
- 094 Influence air removal performance of steam sterilization processes.pdf (153.5 KiB)
- 101 Reasons for wet goods at the end of stem sterilization processes.pdf (106.7 KiB)
- 129 Advantage using PCDs to monitor steam sterilization processes.pdf (45.8 KiB)
- 176 Selection of the correct type test or BD-test for an installed sterilizer.pdf (93.4 KiB)
1.1.1 BDS-Test
1.1.2 Small sterilizers
1.1.4 Prion program
1.3 LTSF
1.4 VHPO
2.0 Chemical indicators
- 035 Differences in the colour change of CI.pdf (42.5 KiB)
- 044 Definition of chemical indicators EN ISO 11140-1.pdf (113.3 KiB)
- 049 Temperature-time-window of gke chemical indicators.pdf (56.5 KiB)
- 148 Use of chemical indicators for steam sterilization processes in programs with longer plateau period then the indicated SV.pdf (25.4 KiB)
2.1 Type 1
3.0 Biological indicators
- 067 Population determination of biological indicators.pdf (92.9 KiB)
- 086 Does it make sense that a PCD can increase the resistance of a BI.pdf (64.0 KiB)
- 107 RIT (Reduced incubation Time).pdf (83.7 KiB)
- 110 Procedure in case of positive results of BIs.pdf (151.6 KiB)
- 113 Suitability of PCDs for SCBIs.pdf (257.6 KiB)
- 149 Holding Time Biological indicators.pdf (48.9 KiB)
3.1 Suspensions - Stearo-Ampoules
3.3 SCBI - Instant-SCBI
3.4 Incubators - Incubation
4.1 Strips CI-BI
4.2 Bio-PCDs
5.0 Documentation
5.2 Labels for printers
5.3 Autoclave tape
6.0 Cleaning - CPI
- 115 Protein test to release cleaned instruments is not sufficient.pdf (72.4 KiB)
- 117 Monitoring of cleaning processes.pdf (67.4 KiB)
- 126 Best practise to select a cleaning indicator.pdf (131.3 KiB)
- 166 gke Cleaning Process Monitoring Indicators (CPI) must not be stored together with any chemical product.pdf (45.7 KiB)
- 167 Test of CPI in the Spray Rig.pdf (153.4 KiB)
- 119 When do CPI have to be used in cleaning processes.pdf (62.9 KiB)