5075HSG - Autoclave clase BStandards and Directives

The 5075HSG autoclave 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 2002/95, 96

Technical Standards

• EN 61010-1:2001, EN 61010-2-040:2005 - Safety of Autoclaves
• EN 13060:2004, EN285:2006 and AAMI/ANSI ST55 - Steam Autoclaves
• ST8 - Hospital Autoclaves
• EN 61326 EMC Requirement
• EN 13445 an EN 14222
• ASME Code, Section VIII for Pressure Vessels

Quality Standards

Tuttnauer manufacturing plants meet the following quality standards:

• ISO 9001:2008 - Quality Systems
• ISO 13485:2003 - Quality Systems for Medical Devices
• 21 CFR 820