This document specifies 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, can be
applicable. Further details are given in 7.2.1.2.
The requirements which are specified in this document are not intended to require the re-design or retesting of implants which have been legally marketed and for which there is a history of sufficient and
safe clinical use. For such implants, compliance with this document can be demonstrated by providing
evidence of the implant’s sufficient and safe clinical use.
Cross References:ISO 7206-1
ISO 7206-2
ISO 7206-4
ISO 7206-6
ISO 7206-10
ISO 14242-1
ISO 14242-2
ISO 14242-3
ISO 14630:2012
ISO 21534:2007
ASTM F3047M-15
93/42/EEC
Incorporates the following:Amendment, January 2017. Amends and replaces BS EN ISO 21535:2009
| File Size : | 1
file
, 1.8 MB |
| ISBN(s) : | 9780539038002 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 44 |
| Published : | 07/31/2024 |
