Standards and Directives
The 5075HSG autoclave complies with the strictest international standards and directives:
Quality Standards
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ISO 9001:2008 - Quality Management SystemsEN ISO 13485:2012 Quality Management System – Medical Devices
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In compliance with 21 CFR part 820 & part 11
Directives
- MDD 93/42/EEC amended in Directive 2007/47/EEC
- PED 97/23/EC - Pressure Equipment Directive
- 2002/96/EC WEEE and 2002/95/EC RoHS
Technical Standards
- EN 285: 2006+A2: 2009 Large steam sterilizer
- EN 13060: 2004+A2: 2010 - Small steam sterilizer
- 2EN 61010-1: 2010 Safety Requirements for measurement control and laboratory use
- EN 61326-1: 2006 Electrical Equipment for EMC requirements
- EN 61010-2-40: 2005 Safety requirements for sterilizers used to treat medical materials
- EN 17665-1: 2006 Sterilization of health care products – moist heat
- ANSI \ AAMI – ST 8: 2008 Hospital steam sterilizers
- ANSI \ AAMI – ST55: 2010 Table Top steam sterilizer
- ASME Code section I and section VIII. Div.I