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In addition to EN ISO 21535:2009, the new version of DIN EN ISO 21535 also includes amendment A1:2016, which was adopted in 2016. Both were combined in a consolidated version. In addition to updating the normative references, Amendment A1:2016 includes some minor changes and the revision of Subclause 7.2 "Preclinical evaluation".
This document replaces DIN EN ISO 21535:2009-08 .