Instructions for Use
Safestik
Serial no.: 2011xxxxx
Version: 4 | Release date: 14. July 2021
Page 53
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Safety of Product and Material
The manufacturer develops, produces and tests its products
according to the essential requirements of MDR 2017 / 745 and
the safety standards of DIN EN 60601-1.
All materials which are used are carefully selected and
correspond to the biocompatibility requirements (in accordance
with ISO 10993-1 ff) and those of the RoHS directive 2011 / 65 /
EU (RoHS II). All materials in contact with the patient were
evaluated and tested according to DIN EN ISO 10993-1:2017-
04 "Biological evaluation of medical devices" (biocompatibility).
Safestik is a class I active medical device. Conformity with the
underlying standards and directives is certified in the declaration
of conformity which is included in the documentation
accompanying the device.
