Instructions for Use
Spirostik Blue
Serial no.: 2111xxxxx
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).
Spirostik Blue 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.
