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BSI BS EN ISO 14630:2024

Non-active surgical implants. General requirements
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BSI BS EN ISO 14630:2024

Non-active surgical implants. General requirements

PUBLISH DATE 2025
PAGES 38
BSI BS EN ISO 14630:2024
This document specifies general requirements for non-active surgical implants, hereafter referred to as implants. This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue. With regard to safety, this document specifies 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 requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards. NOTE 1        This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety. NOTE 2        In this document, when not otherwise specified, the term 'implant' refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.
SDO BSI: British Standards Institution
Document Number ISO 14630
Publication Date Jan. 17, 2025
Language en - English
Page Count 38
Revision Level
Supercedes
Committee CH/150
Publish Date Document Id Type View
Jan. 17, 2025 BS EN ISO 14630:2024 Revision
Dec. 31, 2012 BS EN ISO 14630:2012 Revision
Nov. 30, 2009 BS EN ISO 14630:2009 Revision
Dec. 31, 2008 BS EN ISO 14630:2008 Revision
Aug. 2, 2005 BS EN ISO 14630:2005 Revision
Jan. 15, 1998 BS EN ISO 14630:1998 Revision