Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Version: 7
| Release date: 14. July 2021
Page 83
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).
Spirostik Complete 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.
