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AAMI TIR49 : 2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS
Available format(s)

Hardcopy , PDF

Superseded date

04-18-2020

Language(s)

English

Published date

01-01-2013

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Superseded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

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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