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ISO 21535:2023

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

05-07-2023

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 re-testing 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.

Committee
ISO/TC 150/SC 4
DocumentType
Standard
Pages
27
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
NS-EN ISO 21535:2024 Identical
UNI EN ISO 21535:2024 Identical
NF EN ISO 21535:2024 Identical
DS/EN ISO 21535:2024 Identical
DS/ISO 21535:2023 Identical
PNE-prEN ISO 21535 Identical
ÖNORM EN ISO 21535:2024 10 15 Identical

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