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OxyMag_rev26
17.
Statement of Biocompatibility
This is to state, under our sole responsibility, that all materials used in parts (as defined in standard NBR IEC 60601-1) applied to
Oxymag has been widely used in the medical field overtime, no effects related to toxicity or tissue effects, thus ensuring their
biocompatibility.
And, according to standard ISO-10993-1 Biological evaluation of medical devices
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Part 1: Evaluation and testing
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clause 4.2.1
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the ventilator, its parts and accessories are classified as device without direct or indirect contact with the patient body; therefore, the
ventilator, its parts and accessories are not included in the scope of this standard.
•
Common accessories purchased from third parties MUST comply local legal government
requirements.
