M00028561
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MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING, AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
International Organization for Standardization
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Availability date: 11/05/2021
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
This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.The purpose of this part of ISO 15223 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 210 |
Supersedes |
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