BS EN 16442:2015
$198.66
Controlled environment storage cabinet for processed thermolabile endoscopes
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 64 |
This European Standard specifies the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing. The storage cabinets are designed to provide a controlled environment for storage of endoscope(s), with or without channels, and when necessary drying of the endoscope(s), including the endoscope(s) channels. The controlled environment provided by the storage cabinet ensures that during storage there is no deterioration of the microbiological quality of the endoscope. The drying function is intended to supplement, if necessary, any drying provided as part of the automated or manual processing cycle. This European Standard specifies storage cabinets which flush the channels and the external surfaces of endoscopes with air. NOTE 1 The storage cabinet is one of the means that can allow the safe use of the endoscope for an extended period from the time of processing and improve availability for emergency use. NOTE 2 Thorough drying of an endoscope in a washer-disinfector can require a prolonged cycle time; the use of a storage cabinet including a drying function can enhance throughput of the endoscopes. The cabinet is not intended to provide any cleaning or disinfection function. This European Standard does not include the use of other chemicals for drying and maintaining the quality of endoscopes during storage
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Contents Page |
| 6 | Foreword |
| 7 | Introduction |
| 8 | 1 Scope 2 Normative references 3 Terms and definitions |
| 9 | 4 Performance requirements 4.1 General |
| 10 | 4.2 Storage 4.3 Drying |
| 11 | 4.4 Endoscope storage cabinet connectors (ESC connectors) 4.4.1 General 4.4.2 ESC connector qualification 5 Mechanical and procedure requirements 5.1 Materials – design, manufacture and assembly |
| 12 | 5.2 Air quality 5.2.1 Air supplied to the storage cabinet 5.2.1.1 General 5.2.1.2 Compressed air 5.2.2 Environmental conditions inside the storage cabinet 5.2.2.1 General 5.2.2.2 Overpressure |
| 13 | 5.2.2.3 Air changes 5.2.2.4 Particulate contamination 5.2.2.5 Temperature control 5.2.2.6 Pressure 5.3 Contamination of the storage cabinet chamber surfaces 5.4 Drying process control |
| 14 | 5.5 Endoscope channel aeration system |
| 15 | 5.6 Automatic temperature control 5.7 Fault indication/monitoring |
| 16 | 5.8 Cycle indicators 5.9 Instruments and control devices |
| 17 | 5.10 Temperature indicators 5.11 Relative humidity indicator 5.12 Pressure indicators |
| 18 | 5.13 Traceability 5.14 Double-ended storage cabinets |
| 19 | 6 Testing for conformity 6.1 General 6.2 Air changes 6.3 Overpressure 6.3.1 Reagents and/or materials 6.3.2 Procedure |
| 20 | 6.3.3 Acceptance criteria 6.4 Drying 6.4.1 Principle 6.4.2 Reagents and/or materials 6.4.3 Exterior surface drying 6.4.3.1 Procedure 6.4.3.2 Expression of results 6.4.4 Channel drying 6.4.4.1 Procedure |
| 21 | 6.4.4.2 Expression of results 6.5 Contamination of the inside surfaces of the storage cabinet 6.5.1 Procedure 6.5.2 Acceptance criteria 6.6 Air quality 6.6.1 Air cleanliness 6.6.1.1 Principle 6.6.1.2 Reagents and/or materials 6.6.1.3 Procedure |
| 22 | 6.6.1.4 Acceptance criteria 6.6.2 Moisture content 6.6.2.1 Reagents and/or materials 6.6.2.2 Procedure 6.6.2.3 Acceptance criteria 6.6.3 Oil content 6.6.3.1 Reagents and/or materials 6.6.3.2 Procedure |
| 23 | 6.6.3.3 Acceptance criteria 6.7 Channel aeration test 6.7.1 Principle 6.7.2 Procedure 6.7.3 Acceptance criteria 6.7.4 Endoscope channels blockage test 6.8 Thermometric testing 1 – chamber and load temperature testing 6.8.1 Reagent and/or materials 6.8.2 Procedure |
| 24 | 6.8.3 Acceptance criteria 6.9 Thermometric test 2- chamber and load temperature testing 6.9.1 Procedure 6.9.2 Acceptance criteria 6.10 Readability 6.11 Tests for air filtration 6.11.1 Procedure 6.11.2 Acceptance criteria 7 Documentation 8 Information to be supplied with the storage cabinet 8.1 General |
| 25 | 8.2 Information to be supplied before delivery |
| 27 | 8.3 Marking and labelling 8.4 Packaging 9 Information to be requested from the purchaser by the manufacturer |
| 28 | Annex A (informative) Summary of test programmes Table A.1 — Summary of tests |
| 30 | Annex B (informative) Cross-contamination between endoscopes B.1 Type-testing 1 B.1.1 Objective B.1.2 Principle B.1.3 Reagent and/or materials B.1.4 Procedure B.1.4.1 Endoscope sampling procedure B.1.4.2 Sample analysis B.1.4.3 Endoscope cleaning-disinfection procedure B.1.4.4 Test bacterial suspension B.1.4.5 Endoscope contamination |
| 31 | B.1.4.6 Test B.1.4.7 Acceptance criteria B.2 Type-testing 2 B.2.1 Objective B.2.2 Principle B.2.3 Reagents and/or materials B.2.4 Procedure B.2.4.1 Endoscope sampling procedure |
| 32 | B.2.4.2 Sample analyses B.2.4.3 Endoscope cleaning-disinfection procedure B.2.4.4 Test bacterial suspension B.2.4.5 Endoscope contamination B.2.4.6 Test B.2.4.7 Acceptance criteria |
| 33 | Annex C (normative) Methods for evaluation of airborne microbial contamination in the storage cabinet C.1 General C.2 Active sampling C.3 Sedimentation |
| 34 | Annex D (informative) Procedure for parametric performance qualification D.1 Principle D.2 General |
| 35 | D.3 Relative humidity D.3.1 Materials D.3.2 Procedure |
| 36 | D.3.3 Acceptance D.4 Oil content D.4.1 Materials D.4.2 Procedure D.4.3 Acceptance D.5 Air volume D.5.1 Materials D.5.2 Procedure D.5.3 Acceptance D.6 Particulate contamination D.6.1 Materials |
| 37 | D.6.2 Procedure D.6.3 Acceptance D.7 Pressure D.7.1 Materials D.7.2 Procedure D.7.3 Acceptance |
| 38 | D.8 Air flow rates D.8.1 Materials D.8.2 Procedure D.8.3 Acceptance D.9 Drying time D.9.1 Materials D.9.2 Procedure |
| 39 | D.9.3 Acceptance D.10 Automatic control of channel aeration (if fitted) D.10.1 Materials D.10.2 Procedure D.10.3 Acceptance |
| 40 | Annex E (normative) Internal residual contamination of endoscopes after storage E.1 Type testing E.1.1 Objective of the test E.1.2 Principle E.1.3 Reagents and/or materials E.1.3.1 Test devices |
| 41 | E.1.3.2 Bacterial strain E.1.3.3 Sampling solution E.1.3.4 Diluent E.1.3.5 Maintenance and counting medium E.1.4 Procedure E.1.4.1 Test device sampling procedure E.1.4.2 Sample analysis |
| 42 | E.1.4.3 Test devices cleaning-disinfection procedure E.1.4.4 Test bacterial suspension E.1.4.5 Test device contamination E.1.4.6 Preliminary testing E.1.4.6.1 Determination of the efficiency of the test device contamination method |
| 43 | E.1.4.7 Procedure |
| 46 | E.1.4.8 Acceptance criteria E.2 Performance qualification and routine testing E.2.1 General E.2.2 Procedure |
| 47 | E.2.3 Acceptance criteria |
| 48 | Annex F (normative) Establishing endoscope type test groups F.1 Introduction F.2 Establishing endoscope type test groups |
| 49 | F.3 Choosing relevant type test groups for type testing Table F.1 — Example for establishing relevant endoscope type test groups for storage cabinet type testing F.4 Definition of relevant surrogate devices and endoscopes for type testing |
| 50 | F.5 Verification procedure for new endoscopes |
| 51 | F.6 List of Endoscope blocks Table F.2 — Examples of specified endoscope blocks |
| 57 | Annex G (normative) Establishing endoscope product families G.1 General G.2 Classification of endoscope product families G.2.1 Endoscope product family 1 |
| 58 | Figure G.1 — Example of an endoscope product family 1 G.2.2 Endoscope product family 2 |
| 59 | Figure G.2 — Example of an endoscope product family 2 G.2.3 Endoscope product family 3 |
| 60 | Figure G.3 — Example of an endoscope product family 3 |
| 61 | Bibliography |
