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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
EN ISO 11737-1:2006 Standard
Anyway is still possible use the "EN 1174-1:1996 (EN 1174-2:1996 EN 1174-3:1996)" until October 31st, 2006
Active implantable medical devices Directive (90/385/EEC)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005
Active implantable medical devices Directive (90/385/EEC)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...
Active implantable medical devices Directive (90/385/EEC)
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...
Active implantable medical devices Directive (90/385/EEC)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Active implantable medical devices Directive (90/385/EEC)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...
Active implantable medical devices Directive (90/385/EEC)
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a...
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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