Withdrawn
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.
Directives related to this standards.
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WITHDRAWN
SSH EN ISO 14630:2009
95.99
Withdrawal of Standard
Apr 18, 2013
PUBLISHED
SSH EN ISO 14630:2012
Shqip