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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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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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)

PDF

Language(s)

English

Published date

01-01-2010

Superseded date

12-11-2021

£85.57
Excluding VAT
Summarise this standard

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Superseded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

⚠

A newer version of this standard is available.

View Current Edition
£85.57
Excluding VAT