STANDARDS, DIRECTIVES & CERTIFICATIONS

There are a wide variety of Standards, Directives and required Certifications associated with bringing a medical device to market. This is not different for Steute's foot-operated switches, 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 right.

You'll need Acrobat Reader to view these files. If you don't have this free plug-in you can download it on Adobe's website.