AAMI ST15883 1 2009 R2023
$177.85
ANSI/AAMI ST15883-1:2009/(R)2023 & A1:2014 & A2:2012: Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 |
This document specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST15883-1:2009/(R)2023, Washer-disinfectors — Part 1:General requirements, terms and definitions and tests |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 12 | Background of ANSI/AAMI adoption of ISO 15883-1:2006 |
| 13 | U.S. Deviations to ISO 15883-1:2006 |
| 19 | Foreword |
| 20 | Introduction |
| 21 | 1 Scope 2 Normative references |
| 22 | 3 Terms and definitions |
| 29 | 4 Performance requirements 4.1 General |
| 30 | 4.2 Cleaning 4.2.1 General |
| 31 | 4.2.2 Flushing stage 4.2.3 Washing stage 4.3 Disinfection 4.3.1 Thermal disinfection |
| 32 | 4.3.2 Chemical disinfection 4.3.3 Thermal and chemical disinfection 4.4 Rinsing |
| 33 | 4.5 Drying 4.6 Process chemicals |
| 34 | 5 Mechanical and process requirements 5.1 Materials, design and manufacture/construction |
| 35 | 5.2 Safety 5.3 Calorifiers and tanks 5.3.1 Disinfection of systems within the WD |
| 36 | 5.3.2 Tanks 5.4 Loading and unloading doors and their controls 5.4.1 General |
| 37 | 5.4.2 Control of manually operated doors |
| 38 | 5.4.3 Control of doors of a double-ended WD 5.4.4 Internal doors and access ports 5.4.5 Continuous process WDs without doors 5.5 Pipework and fittings 5.5.1 General |
| 39 | 5.5.2 Control valves 5.6 Spray systems |
| 40 | 5.7 Dosing systems 5.8 Load temperature protection |
| 41 | 5.9 Process temperature control limits |
| 42 | 5.10 Switches, gauges and indicating devices 5.11 Process verification |
| 43 | 5.12 Instrumentation and controls |
| 44 | 5.13 Temperature indicating systems |
| 45 | 5.14 Pressure indicating systems |
| 46 | 5.15 Timing equipment 5.16 Operating cycle indicating equipment 5.17 Recording instruments (if fitted) 5.17.1 Requirements for cycle control recorders 5.17.2 Requirements for process verification recorders |
| 48 | 5.18 Control systems |
| 49 | 5.19 Override of automatic control 5.20 Microprocessor control systems |
| 50 | 5.21 Access to software 5.22 Fault indication systems |
| 51 | 5.23 Water supply 5.24 Venting and drainage systems |
| 52 | 5.25 Drainage 5.26 Air filters installed within the WD 5.27 Load handling and supports for use within the WD |
| 53 | 5.28 Trolleys |
| 54 | 5.29 Environment 6 Testing for conformity 6.1 General 6.1.1 Inter-relationship of tests 6.1.2 Conformity of WDs, as supplied, with this part of ISO 15883 |
| 55 | 6.1.3 Conformity of WD, as installed, with this part of ISO 15883 6.1.3.1 Validation 6.1.3.2 Installation qualification 6.1.3.3 Operational qualification 6.1.3.4 Performance qualification |
| 56 | 6.1.4 Certification of validation 6.1.5 Re-qualification |
| 57 | 6.1.6 Process control and monitoring 6.2 Test equipment 6.2.1 Temperature sensors |
| 58 | 6.2.2 Thermometric recording instruments 6.2.3 Calibration 6.3 Tests on doors, interlocks and fault indications 6.3.1 Cycle start interlock |
| 59 | 6.3.2 Door locking during cycle 6.3.3 Door interlocks on double-ended WDs 6.3.4 Cycle complete door interlocks |
| 60 | 6.3.5 Fault indication on sensor failure 6.3.5.1 Principle 6.3.5.2 Procedure 6.3.5.3 Results 6.3.6 Fault indication on service failure 6.3.6.1 Procedure 6.3.6.2 Results 6.3.7 Failed cycle interlock 6.3.7.1 General 6.3.7.2 Procedure 6.3.7.3 Results |
| 61 | 6.3.8 Blocked drain protection 6.3.8.1 General 6.3.8.2 Procedure 6.3.8.3 Results 6.4 Tests on water quality and water volume 6.4.1 General 6.4.2 Quality of final rinse water 6.4.2.1 Sampling |
| 62 | 6.4.2.2 Tests for chemical purity 6.4.2.3 Tests for bacterial endotoxins 6.4.2.4 Tests for microbial quality 6.4.3 Quality of water used during testing |
| 63 | 6.4.4 Volume of water used per stage 6.5 Tests on pipework 6.5.1 Estimation of dead volume of pipework 6.5.1.1 General 6.5.1.2 Equipment 6.5.1.3 Procedure 6.5.1.4 Results |
| 64 | 6.5.2 Free draining of chamber and load carriers 6.5.3 Chamber leak tightness 6.5.4 Free draining (tanks, chamber, load carriers) 6.5.4.1 General 6.5.4.2 Free draining of chamber and load carriers 6.5.4.3 Free draining of tanks 6.5.5 Pipework flow to discharge point 6.5.6 Venting 6.5.6.1 Equipment 6.5.6.2 Procedure |
| 65 | 6.5.6.3 Results 6.5.7 Load contamination from ductwork of the WD 6.5.7.1 Equipment and materials 6.5.7.2 Procedure 6.5.7.3 Results 6.6 Tests on instrumentation fitted to the WD 6.6.1 Verification of calibration |
| 66 | 6.6.2 Legibility 6.7 Tests on load carriers 6.7.1 Load carriers used within the chamber 6.7.1.1 Equipment 6.7.1.2 Procedure |
| 67 | 6.7.2 Trolleys 6.7.2.1 Equipment 6.7.2.2 Procedure 6.8 Thermometric tests 6.8.1 General |
| 68 | 6.8.2 Load temperature test 6.8.2.1 General 6.8.2.2 Equipment 6.8.2.3 Procedure |
| 69 | 6.8.2.4 Results 6.8.3 Chamber wall temperature test 6.8.3.1 Equipment and materials 6.8.3.2 Procedure 6.8.3.3 Results 6.8.4 Temperature tests on tanks 6.8.4.1 Equipment 6.8.4.2 Procedure |
| 70 | 6.8.4.3 Results 6.8.5 Load temperature protection 6.8.5.1 General 6.8.5.2 Equipment 6.8.5.3 Procedure 6.8.5.4 Results 6.9 Chemical dosing tests 6.9.1 Dispensed volume 6.9.1.1 Procedure 6.9.1.1.1 General |
| 71 | 6.9.1.1.2 Volumetric method 6.9.1.1.3 Concentration method 6.9.1.2 Results 6.9.2 Indication of insufficient process chemical for a cycle 6.9.2.1 Procedure 6.9.2.2 Results 6.10 Tests of cleaning efficacy 6.10.1 General |
| 72 | 6.10.2 Cleaning efficacy test 1 6.10.2.1 General 6.10.2.2 Procedure 6.10.2.3 Results 6.10.3 Cleaning efficacy test 2 6.10.3.1 General 6.10.3.2 Procedure |
| 73 | 6.10.3.3 Results 6.10.4 Tests for process residuals 6.10.4.1 General 6.10.4.2 Procedure 6.10.4.3 Results 6.11 Tests of air quality 6.11.1 Procedure 6.11.2 Results |
| 74 | 6.12 Load dryness test 6.12.1 General 6.12.2 Procedure 6.12.3 Results 6.13 Automatic control test 6.13.1 General 6.13.2 Procedure |
| 75 | 6.13.3 Results 7 Documentation 8 Information to be supplied by the manufacturer 8.1 General |
| 76 | 8.2 Before delivery of the WD and for installation |
| 77 | 8.3 At delivery of the WD |
| 78 | 9 Marking, labeling and packaging 9.1 Marking and labeling |
| 79 | 9.2 Packaging 10 Information to be requested from the purchaser by the supplier of the WD |
| 81 | Annex A Test program |
| 85 | Annex B A0 concept — Comparative lethality of moist heat processes |
| 89 | Annex C Test methods for the detection and assessment of residual proteinaceous contamination C.1 Ninhydrin method for the detection of residual proteinaceous contamination C.1.1 General C.1.2 Equipment and materials C.1.3 Procedure C.1.4 Acceptance criteria |
| 90 | C.1.5 Safety aspects C.2 OPA method for the assessment of residual proteinaceous contamination C.2.1 General C.2.2 Equipment and materials C.2.3 Procedure |
| 91 | C.2.4 Acceptance criteria C.2.5 Safety aspects C.3 Semi-quantitative protein test method using the biuret method C.3.1 General |
| 92 | C.3.2 Equipment and materials C.3.3 Sampling C.3.3.1 Sampling using the swab method C.3.3.1.1 General C.3.3.1.2 Procedure |
| 93 | C.3.3.2 Sampling using the rinse method C.3.3.2.1 General C.3.3.2.2 Procedure C.3.4 Test procedure C.3.5 Acceptance criteria |
| 94 | C.3.6 Safety aspects C.3.6.1 Safe handling of chemicals C.3.6.2 Disposal C.3.6.3 Surroundings C.3.6.4 Tested instruments or objects |
| 95 | Annex D Microbiological recovery medium for estimation of bacterial contamination of water D.1 Constituents D.2 Preparation |
| 96 | Annex E Re-qualification and routine testing E.1 Re-qualification E.2 Routine testing |
| 97 | Bibliography |
| 101 | ANSI/AAMI ST15883-1:2009/A2:2012, Amendment 2 Title page |
| 102 | AAMI Standard Copyright information |
| 106 | Contents |
| 107 | Foreword |
| 109 | Annex B: A0 – Comparative lethality of moist heat process B.1 Background B.2 General B.3 A value expressed mathematically |
| 110 | B.4 “Disinfected” |
| 111 | B.5 Control of microbial contamination in rinse water stored in the WD B.6 Disinfection of load B.7 Microbial challenge studies B.7.1 ISO |
| 112 | B.7.2 United States |
| 113 | B.8 Thermal Disinfection – Classification |
| 115 | B.9 Thermal Disinfection – Practical Aspects B.10 Definitions |
| 116 | B.11 References |
| 118 | ANSI/AAMI ST15883-1:2009/A1:2014, Amendment 1 |
| 119 | AAMI Standard Copyright information |
| 120 | Glossary of equivalent standards |
| 123 | Background of ANSI/AAMI adoption of ISO 15883-1:2006/A1:2014 |
| 124 | Foreword |
| 126 | List of amendments |
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