Abstract
ISO 14630:2005 specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.
With regard to safety, ISO 14630:2005 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 Standards.
General information
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Status: WithdrawnPublication date: 2005-05Stage: Withdrawal of International Standard [95.99]
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Edition: 2Number of pages: 13
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Technical Committee :ISO/TC 150ICS :11.040.40
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Life cycle
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Previously
WithdrawnISO 14630:1997
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Now
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Revised by
WithdrawnISO 14630:2008
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