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