Overview
ISO 27185:2012 - Cardiac rhythm management devices - specifies general requirements for the graphical symbols used on implantable cardiac rhythm management devices (pacemakers, ICDs, CRT devices), their packaging and associated documentation. The standard defines which symbols can be used globally to convey information essential for the safe and effective use of these devices, reducing reliance on multiple languages and supporting consistent medical device labeling and regulatory compliance.
Key topics and technical requirements
- Scope and applicability: Symbols listed in the standard (Table 1) are limited to cardiac rhythm management medical devices intended for global marketing and may appear on the device, packaging or documentation.
- Design rules: Symbols must be prepared in accordance with graphical-symbol principles in IEC 80416-1 and ISO 80416-2 (form, arrows, dimensional criteria). Symbol originals are required for formal adoption.
- Alphanumeric use: Alphanumeric characters are excluded from symbolic presentations but may be used in iconic symbols where appropriate.
- Usage and legibility: Manufacturers determine symbol size to ensure legibility for intended use; relative dimensions, line thickness and orientation must match the standard’s representation. Colours and minimum dimensions are not specified.
- Risk management: Use of symbols must be justified by risk management; manufacturers must ensure symbols do not introduce additional risk (see ISO 14971 references).
- Accompanying text: Symbols can be used alone unless statutes require text. Where text is required, the minimum wording should match the symbol “Title” as listed; values associated with symbols should be placed adjacent to the related graphical element.
- Governance: Proposals for new symbols are submitted to ISO/TC 150/SC 6 for review and adoption.
Practical applications
- Manufacturers: Standardize device labeling across multiple markets, reduce translation burden, and streamline product documentation for pacemakers, ICDs and CRT systems.
- Healthcare providers and device users: Improve quick recognition of device type, key parameters and safety-related instructions regardless of language.
- Distributors and regulators: Facilitate consistent registration, post-market surveillance and conformity assessment by using internationally recognized symbols.
- Design and risk teams: Integrate symbol selection into labeling design and risk-management processes to meet regulatory requirements.
Related standards
- ISO 15223-2 - Medical device symbols (symbol development, selection, validation)
- IEC 80416-1, ISO 80416-2 - Graphical symbol creation, form and use
- ISO 14971 - Risk management for medical devices (referenced for risk considerations)
- Product standards cited in ISO 27185 (e.g., ISO 14708‑1, EN 45502‑1) as related device definitions and registration references
Keywords: ISO 27185, cardiac rhythm management, symbols, implantable cardiac devices, medical device labeling, graphical symbols, regulatory compliance, IEC 80416, ISO 15223-2.
Open preview (PDF)Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements
