Performance Testing of Packaging Systems for Medical Devices (ISO 11607)

Over 300 medical device packaging validations per year! Leave the integrity testing of ISO 11607 sterile barrier systems to JBL.

Regarding the packaging and transportation of medical devices that enter the body (such as scalpels, catheters, syringes, etc.), it is necessary to demonstrate that they are sterile until the packaging is opened in the operating room or similar settings (ISO 11607:2019) and to submit and present test reports from a third-party organization. Therefore, when packaging and transporting medical devices, it is essential to conduct ISO 11607:2019 certification testing externally and obtain the test reports. Are you facing any of the following issues regarding ISO 11607 certification testing? - I want to obtain ISO 11607 certification, but I don't know what to do. - I was turned down for ISO 11607 certification testing and don't know where to request it. Based on our track record of over 300 validations of medical device packaging annually, we conduct performance testing of packaging systems in accordance with the testing methods described in Annex B Performance Testing of ISO 11607:2019. We provide a one-stop service from test plan development to test execution and report preparation, so please feel free to contact us for consultation. *For more details, please check the materials available for download in PDF format.

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By using our services, you can gain the following benefits: ◇ We provide a one-stop solution from transportation testing to the integrity evaluation of sterile barrier systems, which shortens the product development lead time and enables early entry into domestic and international markets. ◇ With the extensive support of packaging experts, you can focus on your core business. JBL conducts over 300 validations of medical device packaging annually and is a skilled group with extensive knowledge and experience. We have many ISTA-certified CPLP technologists and technicians in-house, and we gather the latest information through our alliance with ISTA to assist with your testing needs.