• [[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.
bag
quality_public
created
Thu, 19 Mar 2015 18:50:05 GMT
creator
dirkjan
modified
Thu, 19 Mar 2015 18:50:05 GMT
modifier
dirkjan
tags
Term