Safety Of Product And Material - GERATHERM Diffustik Instructions For Use Manual

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
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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).
Diffustik resp. the variant PFTstik 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.
Page 98 Version: 8 | Release date: 16. August 2021