AAMI TIR12 2020 R2023
$149.13
AAMI TIR12:2020/(R)2023 – Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 |
This technical information report (TIR) provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage … Keywords cleaning, decontamination, disinfection, instructions for use, medical device design, sterilizatio
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR12:2020/(R)2023; Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 19 | 4 Device design considerations 4.1 Overview |
| 20 | 4.2 Risk of patient infection based on intended clinical use |
| 21 | 4.3 Physical design considerations |
| 22 | 4.4 Material design considerations 4.4.1 General considerations 4.4.2 Polymeric materials 4.4.3 Metals |
| 23 | 4.5 Human factors considerations 4.6 Cleaning considerations 4.7 Total system design considerations 4.8 Packaging design considerations |
| 24 | 4.9 Disinfection design considerations 4.10 Sterilization design considerations 4.10.1 General considerations 4.10.2 Moist heat (steam) sterilization 4.10.3 Ethylene oxide sterilization 4.10.4 Chemical vapor sterilization 4.10.5 Hydrogen peroxide sterilization |
| 25 | 4.10.6 Dry heat sterilization 4.10.7 Liquid chemical sterilization 4.10.8 Device design considerations for sterilization 5 Validation testing of processing instructions 5.1 Validation 5.2 Evidence |
| 26 | 5.3 Device equivalence (product families) 5.3.1 General considerations 5.3.2 Master products |
| 27 | 5.3.3 Equivalence assessment 5.4 Product functionality/compatibility 5.4.1 General considerations 5.4.2 Determination of functionality |
| 28 | 5.4.3 Testing of functionality 5.5 Cleaning efficacy 5.5.1 General considerations |
| 29 | 5.5.2 Rinsing after cleaning 5.6 Disinfection efficacy 5.6.1 General considerations 5.6.2 Overview 5.6.3 Levels of disinfectant activity 5.6.3.1 General considerations |
| 30 | 5.6.3.2 Chemical disinfectant considerations |
| 31 | 5.6.3.3 Toxicity 5.6.3.4 Efficacy of the process 5.6.3.5 Disinfection acceptance criteria |
| 32 | 5.7 Sterilization efficacy 5.7.1 Moist heat (steam) sterilization processes |
| 33 | 5.7.2 Example 1: |
| 36 | 5.7.3 Sterilization validations for other sterilization processes 5.7.4 Testing procedures 5.8 Biocompatibility and residuals 5.8.1 General considerations |
| 37 | 5.8.2 Ethylene oxide 5.8.3 Other residues 6 Risk analysis and management 6.1 Introduction |
| 38 | 6.2 General considerations 6.3 Risk-based approach 6.4 Labeling considerations 6.5 Risk considerations during device processing |
| 39 | 6.6 Human factors considerations 6.7 Risk mitigation 7 Processing instructions to be provided by the MDM and further information about common health care facility practices 7.1 Overview |
| 40 | 7.2 Pretreatment at the point of use 7.2.1 Information to be provided 7.2.2 Health care facility practice 7.3 Preparation before cleaning 7.3.1 Information to be provided |
| 41 | 7.3.2 Health care facility practice 7.4 Cleaning 7.4.1 General considerations 7.4.2 Initial rinse 7.4.3 Cleaning agents 7.4.3.1 General considerations 7.4.3.2 Specifying cleaning agents |
| 42 | 7.4.3.3 Cleaning methods and equipment 7.4.3.4 General considerations 7.4.3.5 Manual cleaning |
| 43 | 7.4.3.6 Automated cleaning equipment |
| 44 | 7.4.3.7 Rinsing after cleaning 7.4.4 Disinfection |
| 45 | 7.4.5 Drying 7.4.6 Inspection, maintenance and functionality testing 7.4.6.1 General considerations 7.4.6.2 Inspection and verification of cleaning |
| 46 | 7.4.6.3 Reassembly 7.4.7 Packaging 7.4.7.1 General considerations 7.4.7.2 Types of packaging systems used by health care facilities |
| 47 | 7.4.7.3 Packaging and sterilization modalities 7.4.7.4 Information to be supplied to health care personnel 7.4.8 Sterilization 7.4.8.1 General considerations 7.4.8.2 Information to be supplied to health care personnel |
| 48 | 7.4.9 Storage 7.4.10 Transportation 8 Presentation of information 8.1 General considerations |
| 49 | 8.2 Clear and concise instructions 8.3 Use of graphic elements |
| 50 | 8.4 Training/in-services 8.5 Delivery methods of information being presented |
| 51 | Annex A (informative) 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 |
| 52 | A.9 Hydrogen peroxide A.10 Peracetic acid A.11 Ortho-phthalaldehyde |
| 53 | Annex B (informative) Sterilization cycles commonly available in health care facilities B.1 Introduction B.2 Steam sterilization Table B.1—Time and temperature parameters for gravity-displacement steam sterilization cycles in health care facilities Table B.2—Time and temperature parameters for dynamic-air-removal steam sterilization cycles in health care facilities |
| 54 | B.3 Ethylene oxide sterilization Table B.3—Examples of parameters for EO sterilization cycles in health care facilities B.4 Dry heat sterilization |
| 55 | Table B.4—Parameters for dry heat sterilization cycles in health care facilities B.5 Liquid chemical sterilization Table B.5—Examples of parameters for liquid chemical sterilant cycles B.6 Chemical sterilant vapors and hydrogen peroxide Table B.6—Examples of parameters for hydrogen peroxide sterilization cycles in health care facilities |
| 56 | Table B.7—Parameters for chemical vapor sterilization cycles in health care facilities |
| 57 | Annex C (informative) Processing prion-contaminated patient care equipment and environmental surfaces |
| 58 | Annex D (informative) Recommended cleaning processes for critical, semi-critical, and non-critical devices intended to be sterilized D.1 Introduction D.2 Purpose of the flowchart Figure D.1—Flowchart for cleaning of critical, semi-critical devices and non-critical devices intended to be sterilized |
| 59 | D.3 Purpose of the IFU templates D.4 Processing instructions for Category 1 D.4.1 AAMI Cleaning Process 1: Manual only or automated only |
| 60 | D.5 Processing instructions for Category 2 D.5.1 AAMI Cleaning Process 2: Manual plus automated or manual only |
| 62 | D.6 Processing instructions for Category 3 D.6.1 AAMI Cleaning Process 3: Manual and ultrasonic or manual and ultrasonic plus automated |
| 65 | Annex E (informative) Recommended cleaning and/or disinfection processes of non-critical devices not intended to be sterilized E.1 Introduction E.2 Purpose of the flowchart Figure E.1—Standardized cleaning and/or disinfection process flowchart for devices and/or equipment that cannot be sprayed or immersed |
| 66 | E.3 Purpose of the IFU template E.4 Processing Instructions for Category 4: Non-critical devices not intended to be sterilized |
| 67 | Annex F (informative) Disinfection F.1 General discussion Table F.1—Microorganisms listed in descending order of resistance to chemical sterilants and disinfectants |
| 68 | F.2 Disinfection as interim process F.3 Disinfection as the final process F.4 Thermal disinfection |
| 69 | F.5 High-level disinfection F.6 Intermediate-level disinfection F.7 Low-level disinfection F.8 Efficacy of the disinfection process Bibliography |
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