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eLibrary > AAMI TIR12:2020, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers >

AAMI TIR12:2020, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, 2020

AAMI TIR12:2020; Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
Title page
AAMI Technical Information Report
Copyright information
Contents
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Device design considerations [Go to Page]
4.1 Overview
4.2 Risk of patient infection based on intended clinical use
4.3 Physical design considerations
4.4 Material design considerations [Go to Page]
4.4.1 General considerations
4.4.2 Polymeric materials
4.4.3 Metals
4.5 Human factors considerations
4.6 Cleaning considerations
4.7 Total system design considerations
4.8 Packaging design considerations
4.9 Disinfection design considerations
4.10 Sterilization design considerations [Go to Page]
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
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 [Go to Page]
5.1 Validation
5.2 Evidence
5.3 Device equivalence (product families) [Go to Page]
5.3.1 General considerations
5.3.2 Master products
5.3.3 Equivalence assessment
5.4 Product functionality/compatibility [Go to Page]
5.4.1 General considerations
5.4.2 Determination of functionality
5.4.3 Testing of functionality
5.5 Cleaning efficacy [Go to Page]
5.5.1 General considerations
5.5.2 Rinsing after cleaning
5.6 Disinfection efficacy [Go to Page]
5.6.1 General considerations
5.6.2 Overview
5.6.3 Levels of disinfectant activity [Go to Page]
5.6.3.1 General considerations
5.6.3.2 Chemical disinfectant considerations
5.6.3.3 Toxicity
5.6.3.4 Efficacy of the process
5.6.3.5 Disinfection acceptance criteria
5.7 Sterilization efficacy [Go to Page]
5.7.1 Moist heat (steam) sterilization processes
5.7.2 Example 1:
5.7.3 Sterilization validations for other sterilization processes
5.7.4 Testing procedures
5.8 Biocompatibility and residuals [Go to Page]
5.8.1 General considerations
5.8.2 Ethylene oxide
5.8.3 Other residues
6 Risk analysis and management [Go to Page]
6.1 Introduction
6.2 General considerations
6.3 Risk-based approach
6.4 Labeling considerations
6.5 Risk considerations during device processing
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 [Go to Page]
7.1 Overview
7.2 Pretreatment at the point of use [Go to Page]
7.2.1 Information to be provided
7.2.2 Health care facility practice
7.3 Preparation before cleaning [Go to Page]
7.3.1 Information to be provided
7.3.2 Health care facility practice
7.4 Cleaning [Go to Page]
7.4.1 General considerations
7.4.2 Initial rinse
7.4.3 Cleaning agents [Go to Page]
7.4.3.1 General considerations
7.4.3.2 Specifying cleaning agents
7.4.3.3 Cleaning methods and equipment
7.4.3.4 General considerations
7.4.3.5 Manual cleaning
7.4.3.6 Automated cleaning equipment
7.4.3.7 Rinsing after cleaning
7.4.4 Disinfection
7.4.5 Drying
7.4.6 Inspection, maintenance and functionality testing [Go to Page]
7.4.6.1 General considerations
7.4.6.2 Inspection and verification of cleaning
7.4.6.3 Reassembly
7.4.7 Packaging [Go to Page]
7.4.7.1 General considerations
7.4.7.2 Types of packaging systems used by health care facilities
7.4.7.3 Packaging and sterilization modalities
7.4.7.4 Information to be supplied to health care personnel
7.4.8 Sterilization [Go to Page]
7.4.8.1 General considerations
7.4.8.2 Information to be supplied to health care personnel
7.4.9 Storage
7.4.10 Transportation
8 Presentation of information [Go to Page]
8.1 General considerations
8.2 Clear and concise instructions
8.3 Use of graphic elements
8.4 Training/in-services
8.5 Delivery methods of information being presented
Annex A (informative) Liquid chemical disinfectants commonly used in health care facilities [Go to Page]
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
A.9 Hydrogen peroxide
A.10 Peracetic acid
A.11 Ortho-phthalaldehyde
Annex B (informative) Sterilization cycles commonly available in health care facilities [Go to Page]
B.1 Introduction
B.2 Steam sterilization [Go to Page]
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
B.3 Ethylene oxide sterilization [Go to Page]
Table B.3—Examples of parameters for EO sterilization cycles in health care facilities
B.4 Dry heat sterilization [Go to Page]
Table B.4—Parameters for dry heat sterilization cycles in health care facilities
B.5 Liquid chemical sterilization [Go to Page]
Table B.5—Examples of parameters for liquid chemical sterilant cycles
B.6 Chemical sterilant vapors and hydrogen peroxide [Go to Page]
Table B.6—Examples of parameters for hydrogen peroxide sterilization cycles in health care facilities
Table B.7—Parameters for chemical vapor sterilization cycles in health care facilities
Annex C (informative) Processing prion-contaminated patient care equipment and environmental surfaces
Annex D (informative) Recommended cleaning processes for critical, semi-critical, and non-critical devices intended to be sterilized [Go to Page]
D.1 Introduction
D.2 Purpose of the flowchart [Go to Page]
Figure D.1—Flowchart for cleaning of critical, semi-critical devices and non-critical devices intended to be sterilized
D.3 Purpose of the IFU templates
D.4 Processing instructions for Category 1 [Go to Page]
D.4.1 AAMI Cleaning Process 1: Manual only or automated only
D.5 Processing instructions for Category 2 [Go to Page]
D.5.1 AAMI Cleaning Process 2: Manual plus automated or manual only
D.6 Processing instructions for Category 3 [Go to Page]
D.6.1 AAMI Cleaning Process 3: Manual and ultrasonic or manual and ultrasonic plus automated
Annex E (informative) Recommended cleaning and/or disinfection processes of non-critical devices not intended to be sterilized [Go to Page]
E.1 Introduction
E.2 Purpose of the flowchart [Go to Page]
Figure E.1—Standardized cleaning and/or disinfection process flowchart for devices and/or equipment that cannot be sprayed or immersed
E.3 Purpose of the IFU template
E.4 Processing Instructions for Category 4: Non-critical devices not intended to be sterilized
Annex F (informative) Disinfection [Go to Page]
F.1 General discussion
Table F.1—Microorganisms listed in descending order of resistance to chemical sterilants and disinfectants
F.2 Disinfection as interim process
F.3 Disinfection as the final process
F.4 Thermal disinfection
F.5 High-level disinfection
F.6 Intermediate-level disinfection
F.7 Low-level disinfection
F.8 Efficacy of the disinfection process
Bibliography [Go to Page]

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