Instructions for Use
Bodystik
Serial no.: xx|8|301|yyy and 2301xxxxx
Page 106
Version: 7 | Release date: 02. August 2021
13
Safety of Product and Material
The manufacturer develops, produces and tests its products
according to the essential requirements of MDD 93 / 42 EEC
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).
Bodystik is a class IIa 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.
