Standards and Directives
PlazMax has been developed according to the following international standards and directives (partial list):
Standards
- ISO 9001:2008
- ISO 13485:2003
- ISO 14937
- EN 61010-2-040:2005
- EN 60601-1:2006/AC:2010
Directives
- Medical Device Directive 93/42/EC
- CE Medical Device Mark 0344