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)