Standards

The Elara11 meets established International standards and specifications:

USA Standards:

  • ANSI/ AAMI ST55
  • ASME Sec. Vlll, UL 61010A-1
  • UL 61010A-2-041
  • FDA 510(K) Cleared
  • ISO 17665-1
  • The Quality System complies with ISO 13485:2003 and ISO 9001:2008

Canada Standards:

  • CRN, CSA

EU Standards:

  • EN 13060:2004
  • EN 13445
  • EN 61010-1
  • EN 61010-2-041
  • EN 61010-2-040
  • EN 554 EN 61326 EN 61326
  • Complying with MDD 93/42, PED 97/23, RoHS & WEEE Directives