Standards: difference between ISO & EN & NEN

• ISO is a International Standard published by the International Organization for Standardization • EN is a European Standard published by European Commision for Standardization • NEN is a Dutch Standard published by the ”nederlands normalisatie instituut” • Harmonized Standard is a standard accepted for regulatory CE marking compliance. Compliance with harmonized standards provides a presumption of conformity with the corresponding requirements of harmonization legislation (e.g. Medical Device Directive) • The EN ISO 13485:2012 is a harmonized standard (for EU) • For the 13485 the following standards exist – ISO13485:2003 valid for e.g. Canada – EN ISO 13485:2012 valid for EU – Difference between 2003 and 2012 only on Annex ZA, ZB & ZC • FDA does not recognize (yet) the ISO 13485 as standard.