Quality Assurance, Standards and Directives

The Nova sterilizer complies with the strictest international standards and directives:

Technical Directives

• Medical Device Directive 93/42/EEC.
• Pressure Equipment Directive 97/23/EEC.

Technical Standards

• EN 13060:2004 – Small Steam Sterilizers
• ASME Code, Section VIII division 1 for Pressure Vessels
• EN 61010-1:01 –Safety of electrical equipment
• EN 61010-2-041:96 – Particular Requirements for steam autoclaves
• EN 61326:97 – EMC Requirements

Quality standards

The manufacturing plant meets the following quality standards:
EN ISO 9001:2000–Quality System
ISO 13485:2003 –Quality systems –Medical devices