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EN ISO 11138-2:2009 Standard
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Reference
Anyway is still possible use the "EN ISO 11138-2:2006" until March 21st, 2010
Active implantable medical devices Directive (90/385/EEC)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Active implantable medical devices Directive (90/385/EEC)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
Active implantable medical devices Directive (90/385/EEC)
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...
Active implantable medical devices Directive (90/385/EEC)
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...
Active implantable medical devices Directive (90/385/EEC)
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...
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This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity
This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations
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