Instructions for Use
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
Version: 7 | Release date: 02. August 2021
Page 89
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).
Ergostik 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.
