The ISO 11607-2 standard, developed by the International Standards Organization (ISO), describes the requirements for the development and verification of processes for packaging sterilized medical devices. These processes include creating, closing and assembling preformed sterile barrier systems and packaging systems.
The ISO 11607-1 standard also describes the requirements and test methods for materials, preformed sterile barrier systems, and packaging systems that aim to preserve the sterility of medical devices that have been sterilized last until the point of use.
Within the framework of these standards, certain properties of medical devices and packaging systems must remain constant throughout their shelf life. Products can then be subjected to other testing methods to evaluate the performance, aseptic presentation and microbial barrier properties of the packaging system, as well as the performance, functionality and biocompatibility of the contained medical device.
The main applied medical product packaging tests are:
In the test, analysis, measurement and evaluation studies carried out in our organization, national and international standards and applicable legal regulations are complied with and reliable and impartial results are obtained. Medical product packaging testing services are among the numerous tests carried out in this context.
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