AAMI TIR12 2010 RL
$140.90
AAMI TIR12:2010 Red-line Format – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 137 |
This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annexes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR12:2010 – RED-LINE Format AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers – RED-LINE Format |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 12 | Foreword |
| 13 | Introduction 1 Scope 1.1 Inclusions |
| 14 | 1.2 Exclusions 2 Definitions and abbreviations |
| 18 | 3 Design considerations 3.1 Overview 3.2 Categories of medical devices |
| 19 | 3.3 Physical design considerations |
| 20 | 3.4 Material design considerations 3.4.1 General considerations 3.4.2 Polymeric materials |
| 21 | 3.4.3 Metals |
| 22 | 3.5 Total system design considerations 3.6 Misuse-related design considerations 3.7 Device equivalence 3.7.1 General considerations 3.7.2 Product families 3.7.3 Master products |
| 23 | 3.7.4 Equivalence assessment 3.8 Product functionality 3.8.1 General considerations 3.8.2 Determination of functionality 3.8.3 Maintenance and documentation of functionality |
| 25 | 4 Decontamination 4.1 Overview |
| 26 | 4.2 Common hospital cleaning/decontamination agents and procedures 4.2.1 General considerations 4.2.2 Precleaning at the point of use |
| 27 | 4.2.3 Disassembly and sorting 4.2.4 Cleaning, rinsing, and reassembly |
| 31 | 4.2.5 Cleaning methods and equipment |
| 34 | 4.3 Manufacturers’ responsibilities 4.3.1 General considerations |
| 35 | 4.3.2 Water quality for cleaning 4.3.3 Cleaning agents 4.3.4 Cleaning procedures |
| 36 | 4.3.5 Test data and user verification |
| 37 | 5 Disinfection with liquid chemicals 5.1 Overview 5.2 Levels of disinfectant activity 5.2.1 General considerations |
| 38 | 5.2.2 High-level disinfection |
| 40 | 5.2.3 Intermediate-level disinfection |
| 41 | 5.2.4 Low-level disinfection 5.3 Device design considerations for disinfection with liquid chemicals 5.4 Criteria for selecting an appropriate chemical disinfectant |
| 42 | 5.5 Toxicity 5.6 Materials compatibility 5.7 Efficacy of the process |
| 43 | 5.8 Test data and user verification 6 Sterilization 6.1 Overview 6.2 Sterilization processes available for use in health care facilities |
| 44 | 6.3 Device design considerations for sterilization |
| 45 | 6.4 Packaging considerations for sterilization processes 6.5 Sterilization efficacy testing |
| 46 | 6.5.1 General considerations 6.5.2 Moist hear (steam) sterilization |
| 48 | 6.5.3 Microbiological challenges for EO and other sterilization processes 6.5.4 Testing procedures 6.6 Device and sterilization compatibility |
| 49 | 6.7 Evaluation of sterilant residues and aeration or rinsing parameters 6.7.1 General considerations 6.7.2 Ethylene oxide 6.7.3 Other sterilant residues 6.7.4 Rinsing parameters 6.8 Documentation of qualification |
| 50 | 6.9 Information to be supplied to health care personnel |
| 51 | 6.9.1 Lumened devices |
| 52 | Annex A Liquid chemical disinfectants commonly used in health care facilities A.1 Introduction A.2 Phenolics A.3 Quaternary ammonium compounds A.4 Chlorine A.5 Iodophors A.6 Alcohols A.7 Formaldehyde A.8 Glutaraldehyde |
| 53 | A.9 Hydrogen peroxide A.10 Peracetic acid A.11 Ortho-phthalaldehyde |
| 54 | Annex B Sterilization cycles commonly available in health care facilities B.1 Introduction B.2 Steam sterilization |
| 57 | B.3 Ethylene oxide sterilization B.4 Dry heat sterilization |
| 58 | B.5 Liquid chemical sterilization |
| 59 | B.6 Chemical sterilant gases |
| 60 | Annex C Processing CJD-contaminated patient care equipment and environmental surfaces |
| 61 | Annex D Regulatory considerations D.1 General D.2 FDA regulatory classification of medical devices D.2.1 Classification process D.2.2 Class I devices D.2.3 Class II devices |
| 62 | D.2.4 Class III devices D.3 FDA requirements D.3.1 General controls D.3.2 Special controls D.3.3 Premarket clearance |
| 63 | D.4 Labeling and GMP requirements D.4.1 Labeling D.4.2 Quality system (GMPs) |
| 64 | D.5 FDA regulation of sterilizers and LCSs/HLDs D.5.1 General considerations D.5.2 Premarket notification submissions D.5.3 Labeling |
| 65 | D.6 Reprocessing requirements for a specific reusable device |
| 66 | Annex E Bibliography E.1 Cited references |
| 71 | E.2 For further reading |
| 73 | AAMI TIR12:2010 AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers |
| 75 | Title page |
| 76 | AAMI Technical Information Report Copyright information |
| 77 | Contents |
| 79 | Glossary of equivalent standards |
| 81 | Committee representation |
| 84 | Foreword |
| 85 | Introduction 1 Scope 1.1 Inclusions |
| 86 | 1.2 Exclusions 2 Definitions and abbreviations |
| 89 | 3 Design considerations 3.1 Overview 3.2 Categories of medical devices |
| 90 | 3.3 Physical design considerations |
| 91 | 3.4 Material design considerations 3.4.1 General considerations 3.4.2 Polymeric materials |
| 92 | 3.4.3 Metals 3.5 Total system design considerations |
| 93 | 3.6 Misuse-related design considerations 3.7 Device equivalence 3.7.1 General considerations 3.7.2 Product families 3.7.3 Master products |
| 94 | 3.7.4 Equivalence assessment 3.8 Product functionality 3.8.1 General considerations 3.8.2 Determination of functionality 3.8.3 Maintenance and documentation of functionality |
| 95 | 4 Decontamination 4.1 Overview 4.2 Common hospital cleaning/decontamination agents and procedures 4.2.1 General considerations |
| 96 | 4.2.2 Precleaning at the point of use 4.2.3 Disassembly and sorting 4.2.4 Cleaning, rinsing, and reassembly 4.2.4.1 General considerations |
| 98 | 4.2.4.3.2 Enzyme detergents 4.2.4.3.3 Nonenzyme detergents |
| 99 | 4.2.4.3.4 Detergent–disinfectants 4.2.4.4 Final rinsing 4.2.5 Cleaning methods and equipment 4.2.5.1 General considerations |
| 100 | 4.2.5.2 Manual cleaning |
| 101 | 4.2.5.3 Mechanical (automated) cleaning and disinfection |
| 102 | 4.3 Manufacturers’ responsibilities 4.3.1 General considerations |
| 103 | 4.3.2 Water quality for cleaning 4.3.3 Cleaning agents 4.3.4 Cleaning procedures |
| 104 | 4.3.5 Test data and user verification |
| 105 | 5 Disinfection with liquid chemicals 5.1 Overview 5.2 Levels of disinfectant activity 5.2.1 General considerations |
| 106 | 5.2.2 High-level disinfection |
| 108 | 5.2.3 Intermediate-level disinfection 5.2.4 Low-level disinfection |
| 109 | 5.3 Device design considerations for disinfection with liquid chemicals 5.4 Criteria for selecting an appropriate chemical disinfectant |
| 110 | 5.5 Toxicity 5.6 Materials compatibility 5.7 Efficacy of the process 5.8 Test data and user verification |
| 111 | 6 Sterilization 6.1 Overview 6.2 Sterilization processes available for use in health care facilities |
| 112 | 6.3 Device design considerations for sterilization |
| 113 | 6.4 Packaging considerations for sterilization processes 6.5 Sterilization efficacy testing 6.5.1 General considerations 6.5.2 Moist heat (steam) sterilization 6.5.2.1 Microbiological challenges |
| 114 | 6.5.2.2 Air removal |
| 115 | 6.5.3 Microbiological challenges for EO and other sterilization processes 6.5.4 Testing procedures 6.6 Device and sterilization compatibility |
| 116 | 6.7 Evaluation of sterilant residues and aeration or rinsing parameters 6.7.1 General considerations 6.7.2 Ethylene oxide 6.7.3 Other sterilant residues 6.7.4 Rinsing parameters 6.8 Documentation of qualification |
| 117 | 6.9 Information to be supplied to health care personnel |
| 118 | 6.9.1 Lumened devices |
| 119 | Annex A Liquid chemical disinfectants commonly used in health care facilities A.1 Introduction A.2 Phenolics A.3 Quaternary ammonium compounds A.4 Chlorine A.5 Iodophors A.6 Alcohols A.7 Formaldehyde A.8 Glutaraldehyde |
| 120 | A.9 Hydrogen peroxide A.10 Peracetic acid A.11 Ortho-phthalaldehyde |
| 121 | Annex B Sterilization cycles commonly available in health care facilities B.1 Introduction B.2 Steam sterilization |
| 124 | B.3 Ethylene oxide sterilization B.4 Dry heat sterilization |
| 125 | B.5 Liquid chemical sterilization B.6 Chemical sterilant gases |
| 127 | Annex C Processing CJD-contaminated patient care equipment and environmental surfaces |
| 128 | Annex D Regulatory considerations D.1 General D.2 FDA regulatory classification of medical devices D.2.1 Classification process D.2.2 Class I devices D.2.3 Class II devices |
| 129 | D.2.4 Class III devices D.3 FDA requirements D.3.1 General controls D.3.2 Special controls D.3.3 Premarket clearance |
| 130 | D.4 Labeling and GMP requirements D.4.1 Labeling D.4.2 Quality system (GMPs) D.5 FDA regulation of sterilizers and LCSs/HLDs D.5.1 General considerations |
| 131 | D.5.2 Premarket notification submissions D.5.3 Labeling |
| 132 | D.6 Reprocessing requirements for a specific reusable device |
| 133 | Annex E Bibliography E.1 Cited references |
| 136 | E.2 For further reading |
