Eight circular-knit (1) and six flat-knit mediven fabrics (2) were subjected to a patch test by the testing laboratory Dermatest, Münster, to assess primary irritation after a single occlusive application for a duration of 24 hours. Thirty volunteers with (very) dry, normal, oily, or combination skin, and some with sensitive skin, participated in the patch test.
All tested mediven medical compression stockings showed no skin changes in any of the test subjects after 24, 48, and 72 hours. The specialist Dermatest test report confirms that the products are very well tolerated and do not cause adverse skin reactions when used as intended. They received the "very good" seal for their proven skin compatibility.
Patch test: established proof of skin compatibility
The Patch test, with internationally defined rules and guidelines, is considered an established procedure for product testing for skin compatibility. Mediven compression stockings were tested by Dermatest as follows: The test area was untreated and free of acute or chronic skin changes. Circular knitted fabric samples with a diameter of eight millimeters were covered airtight with a special test patch for 24 hours. The first check for possible skin reactions was then carried out 30 to 60 minutes after the patch was removed, with further checks after 24 and 48 hours. Detailed information about the test and the test criteria can be found at https://dermatest.com/services/patch-test/
(1) mediven elegance®, mediven comfort®, mediven® plus, mediven® forte, mediven® angio, mediven® for men, mediven® active, mediven® harmony
(2) mediven® cosy, mediven® mondi, mediven® 550 Bein, mediven® 550 SL, mediven® mondi esprit, mediven® harmony SL
Our conclusion:
When a medical device is approved, human-ecological safety must be demonstrated, e.g. through OEKO-TEX® Standard 100 of product class II or an equivalent certificate.
The proof has thus already been provided and the further investigation described above has substantiated and deepened this claim and proven it again.
