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AAMI ISO 15223-2 : 2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
Available format(s)

Hardcopy , PDF

Superseded date

11-12-2021

Language(s)

English

Published date

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Superseded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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