SSH EN ISO 14630:2009

Implante kirurgjikalë joaktivë - Kërkesa të përgjithshme (ISO 14630:2008)

Non-active surgical implants - General requirements (ISO 14630:2008)

Scope

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.

Related directives

Directives related to this standards.