Medical device packaging testing
- Fast turnaround times
- Personal service from method experts
- Competitive prices
- Result accuracy guarantee
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Testing expert Elina Tenhunen is happy to provide more information on medical device packaging testing.
Stability testing: accelerated and real-time aging
According to the ISO 11607-1 standard, which sets the performance criteria for the packaging systems of terminally sterilized medical devices, the stability of sterile barrier systems must be demonstrated with data from aging studies. Real-time aging tests must be included as part of the assessment, but accelerated aging tests can be performed to support tentative claims about expiration dates while waiting for data from real-time studies.
The ASTM F1980 standard is generally used for accelerated aging testing of medical device sterile barrier systems. It is an FDA-recognized consensus standard, and the agency often allows placing products on the market based on ASTM F1980 test results before real-time aging data are available.
Measurlabs offers both accelerated and real-time aging tests for medical packaging. Contact our experts to get a quote for your material.
Shipping container distribution testing
Testing according to the ASTM D4169 standard can be performed to assess the performance of medical device shipping units during handling, storage, and transportation. The purpose is to ensure that packaging systems withstand typical stresses encountered during these stages, including stacking, vibration, compression, and different climate conditions.
Testing conditions are chosen depending on the expected distribution environment and the level of protection the medical device requires. Contact our experts to get a quote for evaluating your packaging system.
All medical device packaging tests in one place
Measurlabs works with 900+ top laboratories around the world to offer an exceptionally large selection of testing services in one place. Our medical device packaging tests are performed in accredited laboratories, ensuring that you will always get high-quality results compliant with all the relevant regulations and quality systems. We also pride ourselves on competitive pricing, clear test reports, and proactive customer service by industry experts.
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