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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
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EN ISO 11607-1:2009 Standard
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EN ISO 11607-1:2020
EN ISO 11607-1:2020
Directive
Last Official Journal reference
Description:
Purpose
Publication
Reference
Anyway is still possible use the "EN ISO 11607-1:2006" until March 21st, 2010
Active implantable medical devices Directive (90/385/EEC)
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Active implantable medical devices Directive (90/385/EEC)
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...
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)
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...
Active implantable medical devices Directive (90/385/EEC)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
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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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