AAMI ISO 15223-2 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
Hardcopy , PDF
12-11-2021
English
01-01-2010
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 15223-2:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for identification and development of new symbols
5 Process for selecting and validating symbols for inclusion in
ISO 15223-1
6 Classification of risk
7 Concept development
8 Evaluation
9 Acceptance criteria
Annex A (normative) - Information to be provided during the
symbol development process for adoption of a symbol
into ISO 15223-1
Annex B (normative) - ISO/TC 145/SC 3 proposal for graphical
symbols
Annex C (normative) - IEC/SC 3C proposal for graphical
symbol form
Bibliography
Describes a process for developing, registering, and validating symbols for use in the labeling of medical devices.
Committee |
WG 03
|
DocumentType |
Standard
|
Pages |
29
|
PublisherName |
Association for the Advancement of Medical Instrumentation
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
ISO 15223-2:2010 | Identical |
ANSI/AAMI/ISO 15223-2:2010(R2016) | Identical |
ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
ISO 9186-1:2014 | Graphical symbols Test methods Part 1: Method for testing comprehensibility |
IEC 80416-3:2002+AMD1:2011 CSV | Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols |
IEC 80416-1:2008 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration |
ISO 80416-2:2001 | Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows |
ISO 15225:2016 | Medical devices Quality management Medical device nomenclature data structure |
ISO/TR 7239:1984 | Development and principles for application of public information symbols |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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