AAMI ST55 2016 R2023
$125.88
ANSI/AAMI ST55:2016/(R)2023: Table-top steam sterilizers
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 |
This standard establishes minimum construction and performance requirements for small tabletop steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 56.63 liters (2 cubic feet). This standard is the fourth edition of Table-top steam sterilizers, which was first published as an American National Standard in 1997 as ANSI/AAMI ST55:1997. In comparison to the second edition, which was approved in 2003, this new edition covers cassette sterilizers (which were excluded from the scope of previous editions), incorporates revisions of the methodology for testing the biological performance of table-top steam sterilizers with dental handpieces, and includes a requirement that certain sterilizers be tested for noncondensable gases.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST55:2016/(R)2023; Table-top steam sterilizers |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 9 | Foreword |
| 11 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references |
| 12 | 3 Definitions, symbols, and abbreviations |
| 13 | Table 1—Conversions of saturated pressure units at sea level 4 Requirements 4.1 Labeling 4.1.1 Device markings 4.1.1.1 Identification |
| 14 | 4.1.1.2 Safety 4.1.2 Information manual 4.1.3 Service manual |
| 15 | 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 4.2.6 Water supply reservoir 4.3 Sterilizer safety 4.3.1 Interlock |
| 16 | 4.3.2 Prevention of thermal hazards 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 |
| 17 | 4.4.3 Sterilizer temperature control 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 completion 4.4.7 Sterilization fault conditions 4.4.8 Cycle documentation |
| 18 | 4.5 Biological performance of sterilizers 4.6 Mechanical air removal 4.6.1 Air removal (dynamic-air-removal sterilizers) 4.6.2 Air leaks (prevacuum sterilizers) 4.6.3 Air removal (gravity-displacement cycles) 4.7 Moisture retention 4.8 Sterilizer performance certification and recordkeeping 5 Tests |
| 19 | 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 5.2.6 Water supply reservoir 5.3 Sterilizer safety 5.3.1 Interlock 5.3.2 Prevention of thermal hazards 5.3.3 Sterilizer controls for aborting cycles 5.4 Process monitoring and control devices 5.4.2 Chamber temperature 5.4.2.1 Temperature monitoring and recording |
| 20 | 5.4.2.2 Positioning of temperature sensors 5.4.2.3 Accuracy of temperature measurement 5.4.2.4 Resolution of temperature measurement 5.4.3 Sterilizer temperature control 5.4.4 Sterilizer exposure timer 5.4.5 Pressure measurement 5.4.5.1 Chamber pressure indicator 5.4.5.2 Jacket pressure indicator 5.4.6 Cycle completion 5.4.7 Sterilization fault conditions 5.4.8 Cycle documentation 5.5 Biological performance of sterilizers 5.5.1 General testing requirements |
| 21 | 5.5.2 Biological performance with a textile PCD (BI test pack) 5.5.2.1 Construction of the textile PCD |
| 22 | Figure 1—Three-towel PCD (BI test pack) for textile load |
| 23 | Figure 2—Towel folding procedure Figure 3—Completed wrapped textile PCD (BI test pack) 5.5.2.2 Placement of the textile PCD |
| 24 | 5.5.2.3 Cycle operation 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 biological indicators 5.5.3.5 Acceptance criteria |
| 25 | 5.5.4 Biological performance with wrapped instrument PCD (BI test tray) 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 biological indicators 5.5.4.5 Acceptance criteria 5.5.5 Biological performance with dental handpieces 5.5.5.1 Handpiece selection |
| 26 | 5.5.5.2 Inoculation of the handpiece turbine 5.5.5.4 Handpiece placement during test 5.5.5.6 Cycle operation 5.5.5.7 Retrieval of the handpiece and BI 5.5.5.8 Spore recovery and incubation 5.5.5.9 Acceptance criteria |
| 27 | 5.6 Mechanical air removal 5.6.1 Air removal (dynamic-air-removal sterilizers) 5.6.1.1.1 Bowie-Dick-type test pack 5.6.1.1.2 Test pack placement 5.6.1.1.3 Cycle operation 5.6.1.1.4 Acceptance criteria 5.6.2 Air leaks (prevacuum sterilizers) 5.6.2.1 General 5.6.2.2 Test procedure |
| 28 | 5.6.2.3 Acceptance criteria 5.7 Moisture retention 5.7.1 Textile test packs 5.7.1.1 Test pack construction 5.7.1.2 Pack placement 5.7.1.3 Cycle operation 5.7.1.4 Out-of-chamber handling |
| 29 | Figure 4—Folding a surgical towel to yield nine plies (see 5.7.1.1) 5.7.1.5 Acceptance criteria 5.7.2 Wrapped instrument test trays 5.7.2.1 Test tray composition 5.7.2.2 Tray placement 5.7.2.3 Cycle operation 5.7.2.4 Out-of-chamber cooling |
| 30 | 5.7.3 Paper–plastic peel pouches 5.7.3.1 Pouch preparation 5.7.3.2 Pouch placement 5.7.3.3 Cycle operation 5.7.3.4 Out-of-chamber cooling 5.7.3.5 Evaluation of pouch for moisture retention 5.7.2.5 Evaluation of tray for moisture retention 5.8 Sterilizer performance certification and recordkeeping |
| 31 | Annex A (informative) Rationale for the development and provisions of this standard |
| 36 | Annex B (informative) Examples of temperature during the holding time Figure B.1—Unacceptable process Figure B.2—Unacceptable process |
| 37 | Figure B.3—Unacceptable process Figure B.4—Unacceptable process Figure B.5—Acceptable process |
| 38 | Figure B.6—Acceptable process |
| 39 | Annex C (informative) Examples of cycle documentation Figure C.1—Schematic of cycle phases |
| 40 | Figure C.2—Example of a cycle printout |
| 41 | Bibliography |
| 42 | For further reading |
