Glossary Term
ISO 15223 (Medical Device Symbols for Labeling)
Definition
ISO 15223 is an international standard that specifies symbols to be used in medical device labeling, packaging, and accompanying information. These symbols communicate critical information about device usage, regulatory compliance, safety, and handling without relying on text, enabling clear understanding across different languages and regions.
Relevance to the MedTech Industry
ISO 15223 ensures that medical device labeling is consistent, clear, and universally understood. By standardizing symbols, it reduces the risk of misuse, enhances patient safety, and supports regulatory compliance in global markets.
Additional Information & Related Terms
Key Sections of ISO 15223
General Requirements
Defines the scope, intended use, and application of symbols for medical device labeling.
Specific Symbols
Includes symbols for regulatory requirements, such as CE marking, compliance with sterilization processes, single-use indications, and more.
Application of Symbols
Outlines how symbols should be positioned and formatted on packaging, labels, or instructions for use (IFU).
Examples of Symbols from ISO 15223
Sterilized Using Ethylene Oxide: Indicates the sterilization method used.
Use By Date: Communicates the device's expiration date.
Do Not Reuse: Identifies single-use devices to prevent improper reuse.
CE Marking: Indicates conformity with European Union regulations.
Temperature Limits: Specifies safe storage conditions for the device.
Related Terms
Regulatory Compliance: ISO 15223 symbols are critical for meeting EU MDR, FDA, and other regulatory requirements.
Instructions for Use (IFU): Symbols from ISO 15223 are often included in device documentation to enhance clarity.
Packaging Design: Integrates ISO 15223 symbols to ensure usability and compliance.
Sterile Packaging: Incorporates ISO 15223 symbols to convey sterilization methods and handling precautions.