DIN EN ISO 14602:2010-08

This standard specifies particular requirements for non-active surgical implants for osteosynthesis. In addition to ISO 14630, this standard specifies particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. Due to changed essential requirements of the Directive 2007/47/EC of the European Parliament and of the Council the standard has been revised on the initiative of CEN/TC 285 in order to adapt it to the Council Directive 93/42/EEC. DIN EN ISO 14602 does not cover essential requirement 13.3 a) concerning the information on the manufacturer's authorized representative in the European Community and essential requirement 13.3 f) concerning the consistency of the manufacturer's indication of single use in the European Community which are only specific for the European level. The International Standard has been prepared by ISO/TC 150/SC 5 "Osteosynthesis and spinal devices". On the national level the responsible Working Committee is NA 027-02-15 AA "Endoprothese und Osteosynthese" ("Endoprosthetics and osteosynthesis") of NAFuO.