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YY/T 0127.4-2023Biological evaluation of medical devices used in dentistry - Part 4: Bone implant test (English PDF)

口腔医疗器械生物学评价第4部分：骨植入试验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

November 22, 2023

Implementation date

December 1, 2024

Scope

YY/T 0127.4-2023 is the English-translated version of 口腔医疗器械生物学评价第4部分：骨植入试验.

YY/T 0127.4 is Part 4 of the Chinese series on the biological evaluation of dental medical devices, and it covers the bone implant test.

It sets out how a material intended to be placed in bone is assessed for its local biological effect: how the specimen is prepared and implanted, how long it stays, and how the surrounding bone is examined afterwards for inflammation, resorption or failure to integrate.

Bone-contacting dental materials, from implant surfaces to bone graft substitutes and root-end filling materials, are judged on exactly this evidence. It is the document a Chinese reviewer expects a biocompatibility dossier for a bone-contacting dental device to include.

The 2023 edition supersedes the earlier text, so a manufacturer whose biological evaluation plan still cites the previous version is working to a superseded protocol.

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Document preview — YY/T 0127.4-2023

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 22 November 2023 by the National Medical Products Administration and takes effect on 1 December 2024.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

1 Scope

YY/T 0127.4 is Part 4 of the Chinese series on the biological evaluation of dental medical devices, and it covers the bone implant test. It sets out how a material intended to be placed in bone is assessed for its local biological effect: how the specimen is prepared and implanted, how long it stays, and how the surrounding bone is examined afterwards for inflammation, resorption or failure to integrate. Bone-contacting dental materials, from implant surfaces to bone graft substitutes and root-end filling materials, are judged on exactly this evidence. It is the document a Chinese reviewer expects a biocompatibility dossier for a bone-contacting dental device to include. The 2023 edition supersedes the earlier text, so a manufacturer whose biological evaluation plan still cites the previous version is working to a superseded protocol.

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.

Referenced standards

Cited by

YY/T 1794-2021General technical requirements for dental collagen membrane

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