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ISO 14630

Non-active surgical implants - General requirements

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Organization: ISO
Publication Date: 1 December 2012
Status: active
Page Count: 20
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard 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, this International Standard 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 tests are given or referred to in level 2 and level 3 standards.

NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, might be appropriate to help ensure that the implant achieves its intended performance.

Document History

ISO 14630
December 1, 2012
Non-active surgical implants - General requirements
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants,...
January 15, 2008
Non-active surgical implants - General requirements
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials,...
May 1, 2005
Non-active surgical implants - General requirements
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials,...
November 1, 1997
Non-Active Surgical Implants - General Requirements
A description is not available for this item.

References

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