Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-06-2010

Publisher

British Standards Institution

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, selecting and validating symbols for inclusion in ISO 15223-1.

This part of ISO15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO15223-1.

The purpose of this part of ISO15223 is to ensure that symbols included in ISO15223-1 are readily understood by the target group.

If the symbol validation process detailed in this part of ISO15223 has been complied with, then the residual risks, as defined in ISO14971 and IEC62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

This part of ISO15223 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

Committee	CH/210/3
DevelopmentNote	Supersedes 08/30154605 DC. (06/2010)
DocumentType	Standard
Pages	28
PublisherName	British Standards Institution
Status	Current
Supersedes	08/30154605 DC : DRAFT APR 2008

Standards	Relationship
ISO 15223-2:2010	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
EN 980:2008	Symbols for use in the labelling of medical devices

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BS ISO 15223-2:2010

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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