Technical Information
0.0 General
031 Nosocominal infections.pdf (45.6 KiB)- 033 Storage conditions for gke products.pdf (60.8 KiB)
- 090 Barcode and data structure on gke packages.pdf (73.3 KiB)
- 114 Batch Monitoring - User's liabilty.pdf (49.4 KiB)
- 121 Labelling of gke-packages.pdf (50.5 KiB)
- 179 Different package types for shipping.pdf (60.6 KiB)
0.1 Validation
- 025 Information about the validation of sterilization processes.pdf (58.1 KiB)
- 096 Routine monitoring according to EN ISO 17665-1.pdf (73.8 KiB)
- 100 PCDs are required in the validation standard EN ISO 17665-1.pdf (68.8 KiB)
- 160 Direct inoculation.pdf (55.5 KiB)
- 168 Validation procedure for gke BMS.pdf (301.9 KiB)
- 170 Reprocessing of medical devices in exceptional situations.pdf (276.7 KiB)
- 175 According to the validation standard, test devices (PCD) must have a greater penetration challenge than the load.pdf (56.8 KiB)
0.2 Standards and laws
- 013 Classification of gke indicator systems.pdf (47.4 KiB)
- 053 Labeling of gke indicators.pdf (48.2 KiB)
- 085 General Information about EN and ISO Standards.pdf (45.8 KiB)
- 086 Does it make sense that a PCD can increase the resistance of a BI.pdf (49.5 KiB)
- 087 CE-Marking.pdf (55.1 KiB)
- 134 Safety datasheet for GKE PCDs not necessary.pdf (48.3 KiB)
- 174 Are BI and CI medical devices in Europe.pdf (47.1 KiB)
0.3 PCDs
- 018 Durability of Helix-PCDs.pdf (47.1 KiB)
- 028 Comparison of plastic and metal PCDs.pdf (46.9 KiB)
- 039 Use of chemical indicators of third parties with the gke PCDs.pdf (74.5 KiB)
- 048 Where to place BDS and BMS systems in chamber.pdf (49.1 KiB)
- 053 Labeling of gke indicators.pdf (48.2 KiB)
- 055 Changes of EN 285 for large sterilizers.pdf (50.9 KiB)
- 070 Are there PCDs suitable for certain sterilizers.pdf (48.0 KiB)
- 072 BD-Test in small sterilizers.pdf (54.7 KiB)
- 076 Influence of indicator capsule construction on the sensitivity of Helix-PCDs.pdf (71.2 KiB)
- 079 Which chemical indicators should be used in a PCD system.pdf (53.7 KiB)
- 080 GKE BDS-Test replaces BD cotton pack and hollow load test.pdf (59.2 KiB)
- 086 Does it make sense that a PCD can increase the resistance of a BI.pdf (49.5 KiB)
- 088 Design of Compact-PCDs to check the efficacy of sterilization processes.pdf (79.1 KiB)
- 093 DIN 58921 MDS.pdf (98.9 KiB)
- 097 Material Characteristics of PCDs.pdf (73.6 KiB)
- 099 Screw caps and O-rings for Compact-PCDs.pdf (46.0 KiB)
- 102 Reasons for the melting of Compact-PCDs.pdf (46.9 KiB)
- 106 Durability of Compact-PCDs to simulate BD test, type test and batch monitoring tests.pdf (44.7 KiB)
- 113 Construction of PCDs for SCBIs.pdf (241.8 KiB)
- 128 Indicator capsule volumes of PCDs.pdf (144.5 KiB)
- 129 Advantage using PCDs to monitor steam sterilization processes.pdf (48.0 KiB)
- 141 Use of PCD systems.pdf (54.2 KiB)
- 147 PCD Functionality Test.pdf (46.2 KiB)
- 171 EN ISO Standards for type 2 indicator systems according EN ISO 11140-1.pdf (242.9 KiB)
- 175 According to the validation standard, test devices (PCD) must have a greater penetration challenge than the load.pdf (56.8 KiB)
- 176 Selection of the correct type test or BD-test for an installed sterilizer.pdf (50.2 KiB)
0.4 Routine monitoring
- 076 Influence of indicator capsule construction on the sensitivity of Helix-PCDs.pdf (71.2 KiB)
- 111 Thermoelectric measurements with data loggers in hollow devices.pdf (405.1 KiB)
- 114 Batch Monitoring - User's liabilty.pdf (49.4 KiB)
- 156 Is the Helix-Test a batch monitoring system.pdf (45.6 KiB)
- 168 Validation procedure for gke BMS.pdf (301.9 KiB)
1.1 Steam
- 036 Colour change after sterilization war aborted.pdf (199.0 KiB)
- 055 Changes of EN 285 for large sterilizers.pdf (50.9 KiB)
- 081 Incorrect Colour Change of Process Indicators.pdf (47.3 KiB)
- 084 Application Limitations of NCG Detectors.pdf (64.4 KiB)
- 094 Influence air removal performance of steam sterilization processes.pdf (183.0 KiB)
- 101 Reasons for wet goods at the end of stem sterilization processes.pdf (53.8 KiB)
- 129 Advantage using PCDs to monitor steam sterilization processes.pdf (48.0 KiB)
- 176 Selection of the correct type test or BD-test for an installed sterilizer.pdf (50.2 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 (43.4 KiB)
- 044 Definition of chemical indicators EN ISO 11140-1.pdf (112.3 KiB)
- 049 Temperature-time-window of gke chemical indicators.pdf (54.9 KiB)
- 148 Use of chemical indicators for steam sterilization processes in programs with longer plateau period then the indicated SV.pdf (56.7 KiB)
2.1 Type 1
3.0 Biological indicators
- 067 Population determination of biological indicators.pdf (87.1 KiB)
- 086 Does it make sense that a PCD can increase the resistance of a BI.pdf (49.5 KiB)
- 107 RIT Reduced Incubation Time.pdf (83.8 KiB)
- 110 Procedure in case of positive results of BIs.pdf (95.0 KiB)
- 113 Construction of PCDs for SCBIs.pdf (241.8 KiB)
- 149 Holding Time Biological indicators.pdf (46.0 KiB)
- 180 Purity of biological indicators.pdf (43.5 KiB)
3.1 Suspensions - Stearo-Ampoules
3.3 SCBI - Instant-SCBI
- 116 Release of Instant-SCBI.pdf (53.6 KiB)
- 125 Use of SCBI in H2O2 sterilization processes.pdf (71.7 KiB)
- 142 Positive control of SCBI does not grow.pdf (68.9 KiB)
- 151 Drying of growth medium in SCBIs.pdf (42.9 KiB)
- 165 Comparison of SCBIs.pdf (361.8 KiB)
- 183 False negative results of an Instant-SCBI.pdf (123.1 KiB)
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 (56.9 KiB)
- 117 Monitoring of cleaning processes.pdf (49.3 KiB)
- 119 When do CPI have to be used in cleaning processes.pdf (49.8 KiB)
- 126 Best practice to select the correct CPI.pdf (113.9 KiB)
- 166 GKE CPI must not be stored together with any chemical product.pdf (73.8 KiB)
- 167 Test of CPI in the Spray Rig.pdf (135.6 KiB)