ISO 15223-2:2010 PDF

Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

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Title (English):

ISO 15223-2:2010

Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 16
Publication date:: January 15, 2010
Edition:: ISO IS 15223 edition 1 version 1
ICS:: 01.080.20

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Description (English):

ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary. ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

Technical details

Technical committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
SKU: ISO 15223-2:2010

Abstract

Overview - ISO 15223-2:2010 (Symbol development, selection and validation)

ISO 15223-2:2010 is the ISO process standard for the development, selection and validation of graphical symbols used on medical device labels, labelling and supplied information. It complements ISO 15223-1 (general requirements and the symbol set) by specifying how candidate symbols are identified, designed, tested and documented so that they are readily understood by the intended target group. When its validation process is followed, residual risks related to symbol usability are presumed acceptable in the context of ISO 14971 and IEC 62366 unless objective evidence shows otherwise.

Key topics and technical requirements

Need identification: Assess benefits and the intended target group (training, experience, medical knowledge) before proposing a new symbol.
Concept development: Create symbol concepts and originals consistent with graphical standards (e.g., IEC/ISO graphic principles) and consider existing symbols to avoid duplication.
Selection and validation process: A staged process is defined including initial evaluation, second evaluation and final adoption for inclusion in ISO 15223-1.
Testing methodologies: Requires empirical testing such as comprehension testing, memory testing, usability testing and associative/appropriateness ranking-aligned with ISO 9186-1 test methods.
Risk classification and acceptance: Symbols are assessed for safety relevance and evaluated against acceptance criteria; residual usability risks relate to ISO 14971 (risk management) and IEC 62366 (usability engineering).
Documentation requirements: Annexes (e.g., Annex A) list the normative information to be supplied during symbol development for adoption into ISO 15223-1.
Harmonization and registration: Candidate symbols should be coordinated with ISO/TC 145/SC 3 (ISO 7000) or IEC/SC 3C (IEC 60417) for broader registration.

Practical applications

Use ISO 15223-2 when developing new symbols for product labels, instructions for use, packaging panels, and regulatory submissions.
Apply the standard to validate symbols intended to replace or reduce language-dependent text, improving clarity across international markets and minimizing label clutter.
Support risk management and usability engineering by demonstrating that symbol-related risks have been systematically evaluated and mitigated.

Who should use this standard

Medical device manufacturers (labeling, regulatory and human factors teams)
Regulatory authorities assessing labeling and symbol acceptability
Usability engineers and human factors specialists
Standards developers and symbol proposers seeking inclusion in ISO 15223-1

Related standards (for reference)

ISO 15223-1 - General requirements and symbol set
ISO 14971 - Medical device risk management
IEC 62366 - Usability engineering for medical devices
ISO 9186-1, IEC/ISO 80416 series, ISO 7000, IEC 60417

Keywords: ISO 15223-2, medical device symbols, symbol validation, symbol development, labeling, labelling, graphical symbols, ISO 15223-1, usability testing.

Related standards

Standards mentioned in the description

Abstract

Overview - ISO 15223-2:2010 (Symbol development, selection and validation)

Key topics and technical requirements

Need identification: Assess benefits and the intended target group (training, experience, medical knowledge) before proposing a new symbol.
Concept development: Create symbol concepts and originals consistent with graphical standards (e.g., IEC/ISO graphic principles) and consider existing symbols to avoid duplication.
Selection and validation process: A staged process is defined including initial evaluation, second evaluation and final adoption for inclusion in ISO 15223-1.
Testing methodologies: Requires empirical testing such as comprehension testing, memory testing, usability testing and associative/appropriateness ranking-aligned with ISO 9186-1 test methods.
Risk classification and acceptance: Symbols are assessed for safety relevance and evaluated against acceptance criteria; residual usability risks relate to ISO 14971 (risk management) and IEC 62366 (usability engineering).
Documentation requirements: Annexes (e.g., Annex A) list the normative information to be supplied during symbol development for adoption into ISO 15223-1.
Harmonization and registration: Candidate symbols should be coordinated with ISO/TC 145/SC 3 (ISO 7000) or IEC/SC 3C (IEC 60417) for broader registration.

Practical applications

Use ISO 15223-2 when developing new symbols for product labels, instructions for use, packaging panels, and regulatory submissions.
Apply the standard to validate symbols intended to replace or reduce language-dependent text, improving clarity across international markets and minimizing label clutter.
Support risk management and usability engineering by demonstrating that symbol-related risks have been systematically evaluated and mitigated.

Who should use this standard

Medical device manufacturers (labeling, regulatory and human factors teams)
Regulatory authorities assessing labeling and symbol acceptability
Usability engineers and human factors specialists
Standards developers and symbol proposers seeking inclusion in ISO 15223-1

Related standards (for reference)

ISO 15223-1 - General requirements and symbol set
ISO 14971 - Medical device risk management
IEC 62366 - Usability engineering for medical devices
ISO 9186-1, IEC/ISO 80416 series, ISO 7000, IEC 60417

Keywords: ISO 15223-2, medical device symbols, symbol validation, symbol development, labeling, labelling, graphical symbols, ISO 15223-1, usability testing.

ISO 15223-2:2010 PDF

Technical details

Abstract

Overview - ISO 15223-2:2010 (Symbol development, selection and validation)

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards (for reference)

Related standards

Abstract

Overview - ISO 15223-2:2010 (Symbol development, selection and validation)

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards (for reference)

Related standards

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