Page 12 of 110 Pages
3.4.1 Technical Standards
1. ASME Code, Section VIII Division 1 for Pressure Vessels.
2. IEC 61010-1:2001 2nd Ed. – Safety of Electrical Equipment
…… General Requirement.
3. IEC 61010-2-040:2005 – Particular Requirement for Steam
Autoclaves.
4. EN 61326-1:2006– EMC Regulations.
3.4.2 Quality standards
The manufacturing plant meets the following quality standards:
1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices.
3.5 Electrical Data
To Next Page
Loading...
