With the globalization of trade, symbols are frequently used to convey information that is essential for the safe and proper use of medical devices. A new ISO standard proposes a methodology for the development and presentation of symbols related to medical devices which can be understood independently of language.
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, includes methods for validating those candidate symbols being proposed for inclusion in, ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements.
It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where suitable symbols are not standardized.
ISO 15223-2:2010 has been developed by ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, to improve the quality of symbols developed for use in labelling by:
- Establishing the need
- Providing guidance on the development of symbols
- Providing a test methodology to make sure that the candidate symbol is suitable for adoption and use.
Leighton Hansel, convener of the ISO working group that developed the standard comments: "The use of standardized symbols agreed by international consensus avoids the confusion that users may experience when presented with labelling in a number of different languages. There was a need for systematic methodology for the development and presentation of symbols proposed for adoption in ISO 15223-1. Part 2 was developed to meet that need and includes detailed processes to reduce the probability of misinterpretation of symbols".
The standard deals with:
- Principles for identification and development of new symbols
- Process for selecting and validating symbols for inclusion in ISO 15223-1
- Classification of risk
- Concept development
- Acceptance criteria.
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, was prepared by ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, working group WG 3, Symbols and nomenclature for medical devices. It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 86 Swiss francs, through the ISO Store or by contacting the Marketing, Communication & Information department (see right-hand column).