DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 21535
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016); German version EN ISO 21535:2009 + A1:2016
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007 + Amd 1:2016); Deutsche Fassung EN ISO 21535:2009 + A1:2016
Overview
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".
Document: references other documents
Responsible national committee
NA 027-05-05 AA - Endoprosthesis and osteosynthesis
Responsible european committee
CEN/TC 285 - Non-active surgical implants