With the publication of the new edition of ISO 11607-1:2019 early this year, usability requirements for some packaging have come into effect.
The standard, titled Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems addresses packaging for medical products that must be sterilized, in particular.

Chapter 7 – "Usability evaluation for aseptic presentation" specifies requirements for evaluating the usability of the packaging. In particular, the manufacturer must show that users are able to identify where to begin opening the packaging, that they are able to open the packaging without damaging or contaminating the content of the packaging and, finally, that users can present the contents of the opened package aseptically.

Labelling and packaging have been important topics at Use-Lab for several years now, in part because of new requirements for creating and evaluating accompanying documents that IEC 62366 established when the new edition was released in 2015.

Use-Lab sees this update of ISO 11607-1 as a step towards synchronizing regulatory requirements for medical products and towards greater patient safety. Use-Lab will be attending this year's Medical Packaging Conference in Rotterdam on October 9 and 10. Come meet our senior project manager and regulatory affairs manager Thore Reitz. To schedule an appointment with him, click This email address is being protected from spambots. You need JavaScript enabled to view it..