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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