YY 0502-2026Joint replacement implants - Knee joint prostheses - Fundamental requirements (English PDF)

YY 0502-2026 is the English-translated version of 关节置换植入器械 膝关节假体 基本要求.

YY 0502 sets the fundamental requirements for the knee joint prosthesis, and the prefix matters: it is a YY standard without the /T suffix, so compliance is mandatory in China rather than recommended. It covers the knee replacement implant as a device family, the requirements a total or partial knee prosthesis has to satisfy before it can be placed on the Chinese market. Knee arthroplasty is one of the highest-volume implant procedures in China and one where revision surgery is costly enough that the regulator has kept the requirements compulsory. The 2026 edition carries a three-year transition, taking effect on 1 March 2029, which is the longest run-in of any standard in this group and signals how much requalification work it implies. For a manufacturer or an importer of knee systems, this is the governing document.

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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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