AAMI ISO 15223-2 : 2010
Superseded
View Superseded by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
English
01-01-2010
11-12-2021
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Superseded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 |
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