DIN Standards Committee Medicine
DIN EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Irritation und Hautsensibilisierung (ISO 10993-10:2010); Deutsche Fassung EN ISO 10993-10:2013
This European Standard had to be revised as a result of a formal objection by the European Commission to Annexes ZA and ZB concerning the relationship between this European Standard and the essential requirements of Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. In this standard, only Annexes ZA and ZB have been modified; the existing specifications of the standard remain untouched. Since the amendments are only relevant for Annexes ZA and ZB, DIN decided not to publish a draft standard. The responsible German body involved in its preparation is Working Committee NA 027-02-12 AA "Biologische Beurteilung von Medizinprodukten" ("Biological evaluation of medical devices") of the Standards Committee Optics and Precision Mechanics (NAFuO) at DIN.