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EN ISO 11138-3:2009 Standard
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Reference
Anyway is still possible use the "EN ISO 11138-3:2006" until March 21st, 2010
Active implantable medical devices Directive (90/385/EEC)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Active implantable medical devices Directive (90/385/EEC)
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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)
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
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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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