AAMI TIR30 2011 RA 2016
$131.66
AAMI TIR30:2011/(R)2016 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2011 | 60 |
This report is intended as a resource for manufacturers of medical devices who must validate the instructions for reprocessing that they include with their devices. In addition to describing available processes, materials, test methods, and acceptance criteria for cleaning medical devices that are labeled by the manufacturer for reuse and reprocessing, the report also discusses some of the underlying problems and challenges associated with validating a cleaning method. Extensive references and a sample cleaning validation outline and also are included. Keywords
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 12 | Acknowledgments |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions |
| 16 | 2 Definitions, abbreviations, and symbols |
| 18 | 3 Device materials 3.1 Overview 3.2 Types of materials 3.3 Changes in materials and their surfaces produced by reprocessing |
| 19 | 3.4 Selection of materials 3.4.1 General considerations 3.4.2 “Cleanability” considerations |
| 20 | 4 Device design 4.1 Overview 4.2 Design features offering difficulty in cleaning |
| 21 | 4.3 Design considerations |
| 23 | 5 Cleaning processes available in health care facilities 5.1 Overview 5.2 Cleaning agents 5.2.1 General considerations |
| 24 | 5.2.2 Products used in the transport of contaminated items 5.2.3 Detergents 5.2.3.1 Enzyme detergents |
| 25 | 5.2.3.2 Nonenzyme detergents 5.2.3.3 Detergent-disinfectants 5.2.4 Rinsing |
| 26 | 5.2.5 Assessment of cleanliness and residuals 5.2.6 Additional processing 5.3 Cleaning methods 5.3.1 General considerations 5.3.2 Manual cleaning |
| 27 | 5.3.3 Mechanical cleaning |
| 29 | 5.4 User verification of cleaning processes 5.4.1 General considerations |
| 30 | 5.4.2 Markers |
| 31 | 5.4.3 Cleaning verification tests for users 5.5 Cleaning tools and accessories |
| 32 | 5.6 Worker education |
| 34 | 6 Test soils 6.1 Overview 6.2 Scientific data for choice of test soil |
| 35 | 6.3 Test soils and methods for washer–disinfectors 6.4 Other test soils and methods for reusable devices |
| 37 | 7 Test methods, equipment, and acceptance criteria 7.1 Overview 7.2 Soil application 7.3 Test carriers 7.3.1 Surrogate carriers 7.3.2 Medical devices 7.4 Assays of residual soil and bioburden 7.4.1 General considerations |
| 39 | 7.4.2 Methods involving thorough extraction 7.4.3 Tracer methods 7.4.4 In situ methods 7.4.5 Indirect sample elution 7.4.6 Viable bioburden assessments |
| 40 | 7.4.7 Specific tests for various markers 7.4.7.1 Protein 7.4.7.2 Lipids and oils 7.4.7.3 Carbohydrates 7.4.7.4 Endotoxin 7.4.7.5 Hemoglobin |
| 43 | 7.5 Acceptance criteria 7.6 Simulated-use test protocol |
| 45 | 8 Regulatory considerations 8.1 Overview 8.2 U.S. FDA guidance documents 8.3 U.S. standards 8.4 National guidance documents and standards 8.5 International standards |
| 46 | Annex A Cleaning validation protocol |
| 49 | Annex B Determining surface area and volume of a channel |
| 50 | Annex C Bibliography C.1 Cited references |
| 57 | C.2 For further reading |
