YY 0117.2-2024Implants for surgery - Forgings and castings for bone joint prostheses - Part 2: ZTi6Al4V titanium alloy castings (English PDF)

外科植入物骨关节假体锻、铸件第2部分：ZTi6Al4V钛合金铸件

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

July 8, 2024

Implementation date

July 20, 2027

Scope

YY 0117.2-2024 is the English-translated version of 外科植入物骨关节假体锻、铸件第2部分：ZTi6Al4V钛合金铸件.

YY 0117.2 is Part 2 of the Chinese mandatory series on forgings and castings for joint prostheses, covering ZTi6Al4V titanium alloy castings. Titanium alloy is used for the parts of a joint replacement that anchor into bone, where its stiffness closer to bone and its osseointegration behaviour matter more than surface hardness. Cast titanium is harder to control than wrought: the alloy is reactive at melting temperature, oxygen pickup embrittles it, and the resulting structure governs fatigue strength in a component that will be cyclically loaded for decades. The standard controls composition, microstructure and mechanical properties. The YY prefix without /T makes compliance compulsory in China. For an implant manufacturer or its foundry, this is the material specification.

Document preview — YY 0117.2-2024

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
About this edition
Classification and status
How a Chinese national standard is set out
About this English translation

Foreword

This document was issued on 8 July 2024 by the National Medical Products Administration and takes effect on 20 July 2027.

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

1 Scope

Remaining clauses in the full document

2 Normative references
3 Terms and definitions
About this edition
Classification and status
How a Chinese national standard is set out
About this English translation

......
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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