
Certified operations
Instrumentarium Dental operates according to the following international standards and directives:
• Directive 93/42/EEC (Medical Devices Directive)
• ISO 13485:2003
• ISO 9001:2000
• The Quality Management System complies with US law 21 CFR part 820
(Quality System Regulation)
• ISO 14001:2004 Environmental Management System Certification



