Medical Design Briefs - July 2022 - 35

forces of day-to-day life while ensuring patient
comfort.
Most medical pressure sensitive adhesives
(PSAs) are made of either rubber,
acrylic, or silicone-based adhesives.
Each type is best suited to meet
different challenges, including length
of adhesion time, possible allergic reactions,
and patient comfort upon application/removal.
n
Adhesives Testing for Wearables
ISO 11608 is the internationally recognized
standard for testing needle-based
injection systems (NIS) for medical use.
In 2021, a new section of ISO 11608-6 focused
on on-body delivery systems was
released as a draft. While this new section
establishes standard practices for
testing many aspects of these novel drugdelivery
devices, it is still vague in how it
recommends testing the adhesives used
for these devices.
ISO 11608 points toward established
standards like ASTM D3330 for characterizing
the fundamental adhesive properties
of the material. However, it does not
provide recommendations for how to test
the more functional aspects such as the
torsional, shear, and peel forces encountered
by these devices in practice.
ASTM D3330 Methods A and F measure
the peel strength required to remove
pressure-sensitive adhesives from
a standard steel panel or from another
surface of interest at 90° or 180°, respectively.
The adhesive is carefully
applied to the test panel using a mechanical
roller of specified requirements.
The specimen is then peeled
away from the substrate at a set rate,
and the average adhesion force is recorded
over the course of the test.
The peel adhesion value is reported in
N/10 mm. This test mimics removing
an adhesive patch from a patient's skin
and can also serve as a baseline test to
compare back to after a specimen is
conditioned.
Instron's 6800 Series universal testing system
with a Torsion Add-On is used to apply both axial
and torsional loads to adhesives and other materials.
It is used to simulate loads that a wearable
device may experience while being worn by a patient.
(Credit: Instron)
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Medical Design Briefs - July 2022

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