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STANDARDS, DIRECTIVES & CERTIFICATIONS.
There are a wide variety of Standards, Directives and required Certifications associated with bringing a medical device to market. This is no different for Steute's foot-operated controls, each of which is recognized by the authorities as a "Class 1 Accessory."
Among the relevant requirements are compliance with:
- Medical Device Directive (93/42/EEC)
- UL60601
- CSA
- EN ISO 13485
- AP Anesthesia Approved Devices
- CE Requirements
- TÜV Medical Device Requirements
For information on Standards, Directives, & Steute's Certifications, please use the navigation bar at the left with Adobe's Acrobat Reader.
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