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MAGNAMED TECNOLOGIA MÉDICA S/A
15
Biocompatibility Declaration
We declare, under our sole responsibility, that all materials used in parts (as defined in standard NBR
IEC 60601-
1) of the Fleximag’s family have been widely used in the medical field over time, thus ensuring their
biocompatibility.
According to ISO-10993-1 Standard Biological evaluation of medical devices
— Part 1: Evaluation and
testing
– clause 5 – the ventilator, its parts and accessories are classified as a device without direct or indirect
contact with the patient’s body. Therefore, the ventilator, its parts, and accessories are not included in this
standard’s scope.
•
The common accessories acquired from third parties MUST comply with local legislation.
