Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Page 72
Version: 6 | Release date: 14. July 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).
Spirostik 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.
