Applied standards and approvals 
This product conforms to the provisions of the EC directive MDD(93/42/EEC).
The following standards apply to design and/or manufacturing of the products:
•ASTM
•IEC/EN980:1997: Graphical symbol for use in the labeling of medical devices.
•
–Part 1: General requirement for safety.
•
–Part 2: Collateral standard: Electromagnetic compatibility – Requirements and tests.
•ISO 14971 Risk Management
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