AAMI TIR55 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES
Hardcopy , PDF
25-01-2020
English
01-01-2017
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Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Definitions and abbreviations
3 A human factors engineering and design
controls approach to device processing
4 Design of devices for processing
5 Design of processing procedures
6 Design of processing instructions
7 Education, training, and competency
assessment tools
8 Validation
Bibliography
Gives guidance to medical device manufacturers from a human factors perspective on the aspects of product design; design of processing instructions for use (IFU); education and training design; and development, verification, and validation of the device processing process to meet the needs of personnel working in a health care facility processing environment.
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| ISO 9241-9:2000 | Ergonomic requirements for office work with visual display terminals (VDTs) Part 9: Requirements for non-keyboard input devices |
| AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| AAMI TIR22 : 2007 | GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006 |
| CFR 29(PT1910.1000 TO END) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| ISO 13407:1999 | Human-centred design processes for interactive systems |
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