ISO 11607 Label Integrity for Medical Packaging
The integrity of labels on medical packaging is critical to ensure patient safety and compliance with international standards. ISO 11607:2015 specifies the method for determining the resistance of printed, applied or adhered labels to a number of environmental stressors that are representative of real-world conditions during storage and use.
Our comprehensive testing service ensures your packaging complies with this standard. Our team of experts uses advanced equipment to simulate various stresses such as temperature cycling, humidity, abrasion, solvents, and mechanical forces. This allows us to evaluate the label's performance under realistic conditions, ensuring that it remains intact and readable throughout the product lifecycle.
The test process involves several key steps. First, we prepare the specimen according to ISO 11607 guidelines, which include selecting appropriate samples of medical packaging with attached labels. Then, we subject these specimens to a series of environmental stresses designed to mimic real-world conditions. These tests are conducted in controlled environments that closely replicate storage and use scenarios.
After the specimens have been exposed to the stressors, they undergo thorough inspection using high-resolution imaging technology. This allows us to assess any changes or damage to the labels accurately. Our team then generates detailed reports highlighting the results of each test run, providing you with clear insights into how your packaging performs under various conditions.
By choosing our ISO 11607 Label Integrity testing service, you can ensure that your medical packaging meets all relevant standards and regulations. This not only protects patient safety but also enhances your brand’s reputation for quality and reliability. Our rigorous testing process helps identify potential issues early on in the development cycle, allowing for timely corrective actions.
Our lab uses cutting-edge technology to perform these tests efficiently and accurately. The equipment we employ includes climate chambers capable of simulating different temperature ranges and humidity levels, abrasion testers to assess resistance against friction, solvent exposure tanks, and high-powered microscopes for detailed inspections. These tools enable us to provide precise and reliable results that are essential for maintaining compliance with ISO 11607.
Compliance with this standard is crucial not only because it ensures the safety and efficacy of medical devices but also because non-compliance can lead to severe consequences, including fines, product recalls, and damage to your organization’s reputation. By investing in our comprehensive testing service, you are taking a proactive approach towards safeguarding patient welfare and maintaining regulatory adherence.
Applied Standards
| Standard Name | Description |
|---|---|
| ISO 11607:2015 | Specification for the determination of resistance to environmental stressors for printed, applied or adhered labels on medical packaging. |
| Test Procedure | Description |
|---|---|
| Temperature Cycling | The specimen is exposed to cycles of high and low temperatures, simulating storage conditions. |
| Abrasion Testing | The specimen undergoes repeated rubbing against a specified surface to assess label durability. |
| Solvent Exposure | Labels are immersed in solvents commonly found in medical environments to evaluate their resistance. |
Environmental and Sustainability Contributions
Evaluating label integrity through ISO 11607 helps ensure that packaging remains intact, reducing the likelihood of premature detachment or damage. This contributes to better environmental outcomes by minimizing waste associated with compromised packaging.
By ensuring compliance with this standard, you contribute to sustainable practices within your organization and industry. Properly functioning labels are essential for accurate identification and tracking of medical devices, which helps prevent errors in healthcare settings.
Competitive Advantage and Market Impact
Meeting rigorous standards like ISO 11607 can significantly enhance your competitive position by demonstrating a commitment to quality and safety. In today’s highly regulated market, compliance is not just an option but often a necessity for staying in business.
Customers increasingly demand products that meet stringent environmental and health requirements. By providing evidence of compliance through our testing service, you can build trust with your customers and differentiate yourself from competitors who may not adhere to these same standards.
