YY/T 0127.16-2009Biological evaluation of medical devices used in dentistry - Unit 2: Test method - Bone implantation test (English PDF)

YY/T 0127.16-2009 is the English-translated version of 口腔医疗器械生物学评价 第2单元: 试验方法 骨埋植试验.

YY/T 0127.16-2009 belongs to the Chinese recommended series on the biological evaluation of medical devices used in dentistry, and sits in Unit 2 of that series, the unit that holds the test methods.

This part carries the bone implantation test, the method used when a dental material or device has to be assessed for its behaviour in bone tissue rather than in contact with soft tissue or skin.

It therefore serves the biological safety assessment of oral products intended to be placed in bone. The standard is classified C33 in the Chinese system and 11.060.10 in the international one, and it was issued by the State Food and Drug Administration.

It replaced YY/T 0127.4-1998. Issued on 30 December 2009, it has applied since 1 June 2011.

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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.

YY/T 0127.19-2023|YY/T 0127.4-2023|YY/T 0127.10-2009|YY/T 0268-2008|GB/T 16886.6-2022|YY/T 0127.13-2018

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