99.60 Withdrawal effective May 16, 2018
CEN
CEN/TC 285 Non-active surgical implants
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
Legislation related to this standard
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, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN ISO 14607:2007
WITHDRAWN
EN ISO 14607:2009
99.60
Withdrawal effective
May 16, 2018
PUBLISHED
EN ISO 14607:2018