AAMI ST8 2013 RA 2018
$115.49
ANSI/AAMI/ST8:2013/(R)2018 – Hospital steam sterilizers
| Published By | Publication Date | Number of Pages |
| AAMI | 2013 | 43 |
This standard covers minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 56.63 liters (2 cubic feet).
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST8:2013/(R)2018, Hospital steam sterilizers |
| 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 |
| 8 | Committee representation |
| 10 | Foreword |
| 11 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references |
| 12 | 3 Definitions, symbols, and abbreviations |
| 15 | 4 Requirements 4.1 Labeling 4.1.1 Device markings 4.1.1.1 Identification 4.1.1.2 Safety 4.1.2 Information manual |
| 16 | 4.1.3 Service manual 4.2 Sterilizer design, construction, components, and accessories 4.2.1 Pressure requirements 4.2.2 Pressure vessel certification 4.2.3 Electrical components 4.2.4 Corrosion resistance 4.2.4.1 Sterilizer surfaces 4.2.4.2 Loading accessories 4.2.5 Air filters 4.3 Sterilizer safety 4.3.1 Interlock 4.3.2 Prevention of thermal hazards |
| 17 | 4.3.3 Sterilizer controls for aborting cycles 4.4 Process monitoring and control devices 4.4.1 General 4.4.2 Chamber temperature 4.4.2.1 Temperature monitoring and recording 4.4.2.2 Positioning of temperature sensors 4.4.2.3 Accuracy of temperature measurement 4.4.2.4 Resolution of temperature measurement 4.4.2.5 Sterilizer temperature control |
| 18 | 4.4.2.6 Exposure temperature 4.4.3 Thermometric test connection 4.4.4 Sterilizer exposure timer 4.4.5 Pressure measurement 4.4.5.1 Chamber pressure indicator 4.4.5.2 Jacket pressure indicator 4.4.6 Cycle documentation 4.5 Biological performance of sterilizers |
| 19 | 4.6 Mechanical air removal 4.6.1 Air removal (dynamic-air-removal sterilizers) 4.6.2 Air leaks (prevacuum sterilizers) 4.7 Moisture retention 4.8 Sterilizer performance certification and record-keeping |
| 20 | 5 Tests 5.1 Labeling 5.2 Sterilizer design, construction, components, and accessories 5.2.1 Pressure requirements 5.2.2 Pressure vessel certification 5.2.3 Electrical components 5.2.4 Corrosion resistance 5.2.4.1 Sterilizer surfaces 5.2.4.2 Loading accessories 5.2.5 Air filters 5.3 Sterilizer safety 5.3.1 Interlock 5.3.2 Prevention of thermal hazards |
| 21 | 5.3.3 Sterilizer controls for aborting cycles 5.4 Process monitoring and control devices 5.4.1 General 5.4.2 Chamber temperature 5.4.2.1 Temperature monitoring and recording 5.4.2.2 Positioning of temperature sensors 5.4.2.3 Accuracy of temperature measurement 5.4.2.4 Resolution of temperature measurement 5.4.2.5 Sterilizer temperature control 5.4.3 Thermometric test connection 5.4.4 Sterilizer exposure timer 5.4.5 Pressure indicators 5.4.5.1 Chamber pressure indicator 5.4.5.2 Jacket pressure indicator 5.4.6 Cycle documentation |
| 22 | 5.5 Biological performance of sterilizers 5.5.1 General testing requirements 5.5.2 Biological performance with a fabric PCD 5.5.2.1 Construction of the fabric PCD 5.5.2.2 Placement of the fabric PCD 5.5.2.3 Cycle operation |
| 24 | 5.5.2.4 Incubation of BIs 5.5.2.5 Acceptance criteria 5.5.3 Biological performance with liquid loads (if applicable) 5.5.3.1 Test flasks 5.5.3.2 Placement of test flasks 5.5.3.3 Cycle operation 5.5.3.4 Incubation of BIs 5.5.3.5 Acceptance criteria |
| 25 | 5.5.4 Biological performance with wrapped instrument PCD 5.5.4.1 Construction of the wrapped instrument PCD 5.5.4.2 Placement of the wrapped instrument PCD 5.5.4.3 Cycle operation 5.5.4.4 Incubation of BIs 5.5.4.5 Acceptance criteria |
| 27 | 5.5.5 Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items 5.5.5.1 Gravity-displacement cycles for unwrapped nonporous items 5.5.5.1.1 General 5.5.5.1.2 Construction of the PCD 5.5.5.1.3 Placement of the PCD 5.5.5.1.4 Cycle operation 5.5.5.1.5 Acceptance criteria 5.5.5.2 Dynamic-air-removal cycles for single-wrapped or unwrapped nonporous items 5.5.5.2.1 General |
| 28 | 5.5.5.2.2 Construction of the PCD 5.5.5.2.3 Placement of the PCD 5.5.5.2.4 Cycle operation 5.5.5.2.5 Acceptance criteria 5.6 Mechanical air removal tests 5.6.1 Air removal test (dynamic-air-removal sterilizers) 5.6.1.1 Test pack construction |
| 29 | 5.6.1.2 Test pack placement 5.6.1.3 Cycle operation |
| 31 | 5.6.1.4 Acceptance criteria |
| 32 | 5.6.2 Air leak-rate test (prevacuum sterilizers) 5.6.2.1 General 5.6.2.2 Test procedure 5.6.2.3 Acceptance criteria 5.7 Moisture retention tests 5.7.1 Moisture retention with a fabric PCD 5.7.1.1 Construction of the PCD 5.7.1.2 Placement of the PCD 5.7.1.3 Cycle operation 5.7.1.4 Acceptance criteria |
| 33 | 5.7.2 Moisture retention with a wrapped instrument PCD 5.7.2.1 Construction of the PCD 5.7.2.2 Placement of the PCD 5.7.2.3 Cycle operation 5.7.2.4 Acceptance criteria 5.8 Sterilizer performance certification and record-keeping |
| 34 | Annex A (Informative) Rationale for the development and provisions of this standard A.1 Introduction A.1.1 Historical background and scope of the standard |
| 35 | A.1.2 Need for the standard A.2 Normative references A.3 Definitions, symbols, and abbreviations A.4 Rationale for the specific provisions of the standard A.4.1 Labeling |
| 36 | A.4.2 Sterilizer design, construction, components, and accessories A.4.2.1 Pressure requirements A.4.2.2 Pressure vessel certification A.4.2.3 Electrical components A.4.2.4 Corrosion resistance A.4.2.5 Air filters A.4.3 Sterilizer safety A.4.3.2 Prevention of thermal hazards A.4.3.3 Sterilizer controls for aborting cycles A.4.4 Process monitoring and control devices |
| 37 | A.4.5 Biological performance of sterilizers A.4.6 Mechanical air removal A.4.6.1 Air removal (dynamic-air-removal sterilizers) A.4.6.2 Air leaks (prevacuum sterilizers) A.4.7 Sterilizer performance certification and record-keeping |
| 38 | Annex B (Informative) Examples of cycle documentation |
| 43 | Annex C (Informative) Bibliography |
