The Elara 6 sterilizer complies with the strictest international standards and directives:

Technical Directives

  • Medical Device Directive 93/42/EEC
  • Pressure Equipment Directive 97/23/EEC
  • WEEE and RoHS

Technical Standards

  • EN 13060:2004
  • EN 61010-1
  • EN 61010-2-041
  • EN 61326
  • EN 61010-2-040
  • ISO 17665

 

Quality Standards
The manufacturing plant meets the following quality standards:
ISO 9001:2000 – Quality Management Systems
ISO 13485:2003 – Medical devices