Sterile packed medical devices

Frederik R Steenstrup

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Sterile packed medical devices

DTI upholds an internationally recog­nised accreditation to perform testing according to EN ISO 11607 Part 1. This European harmonised stan­dard guides manufacturers of sterile packed medical devices on how to document the product’s efficient, safe, and effective performance in the hands of the intended user. As such, it is designed to meet the essential requirements of the European Medical Devices Directive. Regulatory authorities recognise the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. During the product life cycle, the sterile barrier is challenged with eg. sterilisation which can reduce lifetime.

Short time to market
DTI’s recognised competences within transportation, microbiology, and integrity testing make us a one-stop source of documentation required for a trouble-free CE approval process. Denmark’s national accreditation body, DANAK, inspects and certifies the DTI laboratories that perform the testing according to EN ISO 11607 Part 1. The relevant authorities will simply note that our customers’ application is based on an accredited test report.

Medical device manufacturers often approach DTI with the intention to

  • set up a test protocol together
  • determine peel-open seal strength for safe presentation
  • document shelf life using accelerated ageing approach
  • undertake performance and long term stability testing of packaging system
  • exploit DTI’s knowledge when testing gives an unintended result.