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ISO - DIS 21535

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants

pending
Organization: ISO
Publication Date: 22 July 2021
Status: pending
Page Count: 34
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This document provides specific requirements for hip joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.

This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials.

This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, may be applicable. Further details are given in Clause 7.2.1.1.

The requirements which are specified in this document are not intended to require the re-design or re-testing of devices which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such devices compliance with this document shall be demonstrated by providing evidence of the sufficient and safe clinical use.

Document History

DIS 21535
July 22, 2021
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
This document provides specific requirements for hip joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials,...
November 15, 2016
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants AMENDMENT 1
A description is not available for this item.
October 1, 2007
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance,...
November 1, 2002
Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants
A description is not available for this item.

References

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