AAMI TIR49 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS
English
01-01-2013
18-04-2020
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Using this document
3 Definitions
4 The human performance goal of training and instruction
5 A systematic approach to designing training and
instructions
6 Guidance on media selection
7 Design guidance for use of instructions and training media
8 Case study: Development of an effective training curriculum
for a complex medical device used in the home environment
Bibliography
Specifies a relevant source of information, design criteria, and guidelines for the instructional and training materials and processes intended to accompany medical devices used in a non-clinical environment, which for the purpose of this document, is defined as an environment other than a facility where a health professional is continually present whenever a patient is present.
| DocumentType |
Standard
|
| Pages |
43
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 15/30328959 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| PD IEC/TR 62366-2:2016 | Medical devices Guidance on the application of usability engineering to medical devices |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| ISO 9241-110:2006 | Ergonomics of human-system interaction — Part 110: Dialogue principles |
| ANSI/AAMI HA60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| ISO/TR 9241-100:2010 | Ergonomics of human-system interaction — Part 100: Introduction to standards related to software ergonomics |
| AAMI IEC 62366 : 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| ISO 14915-1:2002 | Software ergonomics for multimedia user interfaces — Part 1: Design principles and framework |
| ISO 14915-3:2002 | Software ergonomics for multimedia user interfaces — Part 3: Media selection and combination |
| AAMI/ISO 13485:2016 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
| ISO 14915-2:2003 | Software ergonomics for multimedia user interfaces — Part 2: Multimedia navigation and control |
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