AAMI TIR55 2014 RA 2017
$93.55
AAMI TIR55:2014/(R)2017 – Human factors engineering for processing medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 32 |
Provides guidance on the application of human factors engineering principles to instructions provided by manufacturers for cleaning medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR55:2014/(R)2017, Human factors engineering for processing medical devices |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 11 | Foreword |
| 13 | Introduction 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Definitions and abbreviations |
| 15 | 3 A human factors engineering and design controls approach to device processing 3.1 General |
| 16 | 3.2 Design and development planning 3.3 Design inputs 3.4 Design outputs |
| 17 | 3.5 Design verification 3.6 Design validation |
| 18 | 4 Design of devices for processing 4.1 General 4.2 Physical characteristics of reusable devices 4.2.1 Weight 4.2.2 Number and size of components and configuration of set |
| 19 | 4.2.3 Color 4.2.4 Sharp internal corners and angles 4.2.5 Dead-end channels and zones 4.2.6 Lumens and channels 4.2.7 O-rings 4.2.8 Springs, coils, and twisted or braided wires 4.2.9 Disassembly and reassembly |
| 20 | 4.2.10 Instrument identification 4.3 Material characteristics of processed devices 4.3.1 Material type 4.3.2 Visual evaluation of cleanliness 4.3.3 Visual evaluation of device degradation 4.3.4 Visual evaluation of rinsing effectiveness 4.3.5 Biofilm 5 Design of processing procedures 5.1 General considerations |
| 21 | 5.1.1 Decontamination area 5.1.2 Prep and packaging area 5.1.3 Sterile storage area 5.2 Processing personnel 5.2.1 General considerations 5.2.2 Use error 5.2.3 Human capabilities |
| 22 | 5.2.4 Human capacity for learning |
| 23 | 5.3 The processing procedure 6 Design of processing instructions 6.1 General considerations for content of IFU 6.1.1 Searching |
| 24 | 6.1.2 Comprehending 6.1.3 Applying 6.2 Language and readability |
| 25 | 6.3 Content 6.4 Images |
| 26 | 6.5 Considerations for printed IFU 6.6 Considerations for electronic IFU |
| 27 | 7 Education, training, and competency assessment tools 7.1 Structure of education and training 7.2 Preparing the trainer 7.3 Key considerations in design and execution of training |
| 28 | 7.4 Competency assessment |
| 29 | 8 Validation 8.1 Human factors validation |
| 30 | 8.2 Personal protective equipment |
| 31 | 8.3 Cleaning, disinfection, packaging, and sterilization validation 8.3.1 General 8.3.2 Cleaning instructions (real-life setting considerations) 8.3.3 Disinfection procedure 8.3.4 Packaging method 8.3.5 Sterilization procedure 8.3.6 Accessories |
| 32 | Bibliography |
