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Medical Device Labeling : Understanding ISO 15223 Standard

Updated: May 23

In the world of medical devices, clear communication is paramount. This is where ISO 15223 standard steps in, providing a standardized set of symbols to convey essential information. This standard ensures that users worldwide can understand crucial details about medical devices quickly and accurately, regardless of language barriers. Here’s a deep dive into what Medical Device Labeling ISO 15223 standard covers and why it’s vital for the medical device industry.

Medical Device Labeling ISO 15223

What is Medical Device Labeling ISO 15223 Standard for ?

 ISO 15223 is the standard - "Medical devices — Symbols to be used with information to be supplied by the manufacturer". It is a critical international standard that ensures the safe and effective use of symbols on medical device labels, labelling, and the information provided with these devices. The standard is designed to provide clear communication and prevent misunderstandings or misuse of medical devices, enhancing patient safety and regulatory compliance. This standard is part of a broader effort to harmonize medical device regulations globally, promoting safety and consistency across different markets.

Structure of Medical Device Labeling ISO 15223 Standard

ISO 15223 consists of two key parts :

  • ISO 15223-1:2021 Part 1 - General Requirements : This section outlines the basic principles and requirements for the use of symbols on medical device labels. It provides guidance on how symbols should be designed, placed, and interpreted to ensure clarity and consistency across the industry.

  • ISO 15223-2:2020 Part 2 - Symbol Development, Selection, and Validation : This part details the process for creating and validating new symbols. It includes criteria for selecting appropriate symbols, ensuring they are universally understood and unambiguous. The validation process involves rigorous testing and review to confirm that symbols convey the intended information effectively.

ISO 15223-1:2021 Part 1 : General requirements for medical device labeling

Key features of ISO 15223-1 2021 are -

  • Standardized Symbols: The standard includes a comprehensive list of symbols that can be used on medical device labels, packaging, and accompanying information. These symbols are designed to be universally understood, minimizing the risk of misinterpretation.

  • Regulatory Compliance: ISO 15223-1:2021 helps manufacturers comply with various international regulatory requirements. By using standardized symbols, manufacturers can ensure their products meet the labeling requirements of multiple regions, including the EU, US, and other global markets.

  • Safety and Clarity: The symbols covered in ISO 15223-1:2021 provide clear, concise information about a device's usage, storage, handling, and other critical aspects. This clarity is essential for ensuring user safety and effective device operation.

Commonly used symbols in medical device labeling

Medical Device Labeling ISO 15223

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

ISO 15223-2:2010 plays a critical role in the development and validation of symbols used in medical device labeling. By following a validation process, manufacturers can ensure their symbols are clear, effective, and compliant with international standards. This not only enhances user safety and communication but also helps in meeting regulatory requirements across different markets. ISO 15223-2:2010 specifies a comprehensive process for validating symbols that are used on medical devices and their labeling.


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Key Steps in the Symbol Validation Process

Symbol Development: