AAMI ST50 2004 RA 2018
$93.55
ANSI/AAMI ST50:2004/(R)2018 – Dry heat (heated air) sterilizers
| Published By | Publication Date | Number of Pages |
| AAMI | 2004 | 41 |
This standard establishes minimum labeling and performance requirements for dry heat (heated air) sterilizers intended for use in dental and medical offices, laboratories, ambulatory-care clinics, hospitals, and other health care facilities.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST50:2004/(R)2018, Dry heat (heated air) sterilizers |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Acknowledgment |
| 11 | Foreword |
| 13 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references 3 Definitions of terms |
| 15 | 4 Requirements 4.1 Labeling 4.1.1 Device markings 4.1.1.1 Identification 4.1.1.2 Hazard labeling 4.1.2 Information manual |
| 16 | 4.1.3 Service manual 4.2 Electrical components 4.3 Loading accessories 4.4 Prevention of thermal hazards 4.5 Sterilizer controls for aborting cycles 4.6 Process control and monitoring devices 4.6.1 Chamber temperature 4.6.1.1 Temperature control and monitoring 4.6.1.2 Positioning of temperature sensors 4.6.1.3 Accuracy of temperature measurement |
| 17 | 4.6.1.4 Resolution of temperature measurement 4.6.1.5 Sterilizer temperature control 4.6.2 Sterilizer exposure timer 4.6.3 Airflow 4.6.4 Cooling 4.7 Biological performance of sterilizers 4.8 Certification and record-keeping 4.9 Software quality assurance 4.9.1 Software developed in-house 4.9.2 Custom-developed software |
| 18 | 4.9.3 Off-the-shelf software 5 Tests 5.1 Labeling 5.2 Electrical components 5.3 Loading accessories 5.4 Prevention of thermal hazards 5.5 Sterilizer controls for aborting cycles 5.6 Process control and monitoring devices 5.6.1 Chamber temperature 5.6.1.1 Temperature monitoring and recording 5.6.1.2 Positioning of temperature sensors 5.6.1.3 Accuracy of temperature measurement 5.6.1.4 Resolution of temperature measurement 5.6.1.5 Sterilizer temperature control |
| 19 | 5.6.2 Sterilizer exposure timer 5.6.3 Airflow 5.6.4 Cooling 5.7 Biological performance of sterilizers 5.7.1 General considerations 5.7.2 Biological-indicator challenge test pack 5.7.2.1 Construction and placement of the test pack 5.7.2.2 Cycle operation 5.7.2.3 Incubation of BIs 5.7.2.4 Acceptance criteria |
| 20 | 5.7.3 Simulated-use tests 5.7.3.1 Test items 5.7.3.2 Placement of BIs and temperature sensors 5.7.3.3 Cycle operation 5.7.3.4 Incubation of BIs 5.7.3.5 Acceptance criteria 5.8 Certification and record-keeping 5.9 Software quality assurance |
| 21 | Annex A Rationale for the development and provisions of this standard A.1 Introduction A.2 An overview of dry heat sterilization A.2.1 Historical perspective A.2.2 How dry heat (heated air) sterilization is accomplished A.2.3 Types of dry heat sterilizers |
| 24 | A.2.4 Variables associated with the dry heat sterilization process A.2.5 How dry heat sterilization is measured A.2.6 Typical items sterilized by dry heat A.3 Need for a standard for dry heat sterilizers |
| 25 | A.4 Rationale for the specific provisions of this standard A.4.1 Labeling A.4.2 Electrical components A.4.3 Loading accessories A.4.4 Prevention of thermal hazards A.4.5 Sterilizer controls for aborting cycles A.4.6 Process control and monitoring devices A.4.7 Biological performance of sterilizers |
| 26 | A.4.8 Sterilizer performance certification and record-keeping A.4.9 Software quality assurance |
| 27 | Annex B Example of a biological-indicator challenge test pack for dry heat sterilizers B.1 Introduction B.2 Composition of a proposed test pack for dry heat sterilizers B.3 Test objective B.4 Methods and materials B.5 Test procedure |
| 28 | B.6 Preliminary test data B.6.1 Sterilizer A (static dry heat sterilizer) |
| 29 | B.6.2 Sterilizer B (forced-air dry heat sterilizer) |
| 31 | B.6.3 Sterilizer C |
| 34 | B.6.4 Sterilizer D |
| 40 | Annex C Bibliography |
