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YY 0118-2026Joint replacement implants - Hip joint prostheses - Fundamental requirements (English PDF)

关节置换植入器械髋关节假体基本要求

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 9, 2026

Implementation date

March 1, 2029

Scope

YY 0118-2026 is the English-translated version of 关节置换植入器械髋关节假体基本要求.

It covers the hip replacement implant as a device family, defining what a stem, head, cup or complete system has to satisfy to be placed on the Chinese market.

Hip prostheses are the implant class with the longest expected service life and the most consequential failure modes, which is why the fundamental requirements have stayed compulsory across editions.

The 2026 edition takes effect on 1 March 2029, a three-year transition that matches the knee standard and gives manufacturers time to requalify existing implant families. For anyone selling hip systems into China, this is the governing document.

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Document preview — YY 0118-2026

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 9 March 2026 by the National Medical Products Administration and takes effect on 1 March 2029.

It is a YY standard without the /T suffix: compliance is mandatory in China.

1 Scope

YY 0118 sets the fundamental requirements for the hip joint prosthesis, and like its knee counterpart YY 0502 it is a YY standard without the /T suffix: compliance in China is mandatory, not recommended. It covers the hip replacement implant as a device family, defining what a stem, head, cup or complete system has to satisfy to be placed on the Chinese market. Hip prostheses are the implant class with the longest expected service life and the most consequential failure modes, which is why the fundamental requirements have stayed compulsory across editions. The 2026 edition takes effect on 1 March 2029, a three-year transition that matches the knee standard and gives manufacturers time to requalify existing implant families. For anyone selling hip systems into China, this is the governing document.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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