Glossary Term
Label Integrity Testing
Definition
Label Integrity Testing is a quality control process used to evaluate the durability, readability, and adhesion of labels on medical devices, pharmaceuticals, or packaging under various conditions. This ensures that critical information, such as instructions, warnings, and regulatory markings, remains intact and legible throughout the product’s lifecycle.
Relevance to the MedTech Industry
Label Integrity Testing ensures compliance with regulatory standards, patient safety, and product usability by verifying that labels withstand real-world handling, storage, and environmental conditions. This is crucial for maintaining trust and preventing misuse or misidentification of medical products.
Additional Information & Related Terms
Examples of Label Integrity Testing
Abrasion Resistance Testing: Verifies the label’s ability to withstand handling and friction.
Environmental Testing: Simulates extreme storage or transportation conditions, such as freezing or high humidity.
Chemical Resistance Testing: Ensures labels resist damage from disinfectants, saline, or other common chemicals.
Legibility Testing: Confirms that printed text, symbols, and barcodes remain readable and scannable.
Adhesive Testing: Evaluates the label’s bond strength on different surfaces over time.
Related Terms
ISO 15223-1: International standard specifying symbols to be used on medical device labels.
FDA 21 CFR Part 801: U.S. regulation governing the labeling of medical devices.
Durability Testing: Broader testing category that includes label performance under physical and environmental stress.
Barcode Validation: Ensures barcodes meet standards for readability and functionality in supply chains.
UDI (Unique Device Identification): A system requiring durable, scannable labels for medical devices to improve traceability.