99.60 Withdrawal effective Dec 1, 2012
CEN/TC 285 Non-active surgical implants
11.040.40 Implants for surgery, prosthetics and orthotics
ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2008 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.
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
EN ISO 14630:2008
EN ISO 14630:2009
99.60 Withdrawal effective
Dec 1, 2012
EN ISO 14630:2012