Instructions for Use
Ambistik PFT-CPET
Serial no:
2024xxxxx / 2025xxxxx
Page 64
Version: 1 | Release date: 31 January 2022
13
Safety of Product and Material
The manufacturer develops, produces and tests its products
according to the essential requirements according to MDR 2017
/ 745 EU as well as according to the safety standards according
to 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).
Ambistik PFT / Ambistik CPET is a class I 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.
