What is EN ISO 15223-2:2018?

EN ISO 15223-2:2018 is a technical standard that provides guidelines for symbols used in medical device labeling. These symbols are essential for conveying important information to individuals who use or come into contact with medical devices. The standard was developed by the European Committee for Standardization (CEN) and adopted as an International Organization for Standardization (ISO) standard.

The Importance of Standardized Symbols

Standardized symbols play a crucial role in ensuring the safe use and understanding of medical devices. With the increasing globalization of the healthcare industry, it is necessary to have a universal system of symbols that can be easily recognized and interpreted regardless of language barriers or cultural differences.

EN ISO 15223-2:2018 provides a comprehensive set of symbols that cover various aspects of medical devices, including warnings, instructions for use, and identification of specific features. By using standardized symbols, manufacturers can improve the clarity and comprehension of their device labels, reducing the risk of misuse or misinterpretation.

Understanding the Symbol Design

The symbols included in EN ISO 15223-2:2018 follow a consistent design approach to enhance recognition and comprehension. They are typically composed of simple shapes, bold lines, and minimalistic details to ensure visibility and legibility, even in small sizes.

Furthermore, the standard specifies color requirements for various symbols, emphasizing the importance of color contrast for people with visual impairments. For example, certain cautionary symbols should be displayed in black on a yellow background to maximize visibility and draw attention to potential risks.

The Evolution of EN ISO 15223-2:2018

EN ISO 15223-2 has evolved over time to accommodate advancements in medical devices and changes in industry regulations. The latest revision, published in 2018, introduced new symbols related to software and wireless communication, reflecting the growing integration of technology in healthcare.

Additionally, the standard now includes specific requirements for symbols used on small medical devices or their packaging. These requirements take into consideration the limited space available while ensuring that the necessary information is still conveyed effectively.