ISO 15223-2:2010 Details Medical Device Symbols, Labeling

ISO 15223-2:2010 Details Medical Device Symbols, Labeling March 30, 2010 // Published as a news service by IHS

The International Organization for Standardization (ISO) released ISO 15223-2:2010 - Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 2: Symbol development, selection and validation. The standard 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, labeling and information to be supplied – Part 1: General requirements. ISO 15223-2 proposes a methodology for the development and presentation of symbols related to medical devices which can be understood independently of language. It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where suitable symbols are not standardized. The standard addresses:      

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 Evaluation Acceptance criteria

ISO 15223-2 was developed 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 to improve the quality of symbols developed for use in labeling 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

With the globalization of trade, symbols are frequently used to convey information that is essential for the safe and proper use of medical devices. "There was a need for systematic methodology for the development and presentation of symbols proposed for adoption in ISO 15223-1," said Leighton Hansel, convener of the ISO working group that developed the standard. "Part 2 was developed to meet that need and includes detailed processes to reduce the probability of misinterpretation of symbols," Hansel said. Source: International Organization for Standardization (ISO).