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YY/T 0511-2009Test method for evaluation of the biodegradation and osteogenesis of porous bioceramic in vivo (English PDF)

多孔生物陶瓷体内降解和成骨性能评价试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 30, 2009

Implementation date

June 1, 2011

Scope

YY/T 0511-2009 is the English-translated version of 多孔生物陶瓷体内降解和成骨性能评价试验方法.

YY/T 0511-2009 is a recommended Chinese medical device standard giving a test method for evaluating the biodegradation and the osteogenesis of porous bioceramics in vivo.

It covers the qualitative and quantitative assessment of how the material degrades once implanted in bone tissue and of the bone formation that follows. Degradation is judged from the decomposition reaction produced in the bone tissue, and osteogenesis from the degree of new bone formed.

The method is written for porous bioceramics implanted in bone without regard to any mechanical or functional load on them. It quotes GB/T 16886.1, GB/T 16886.2, GB/T 16886.6 and GB/T 16886.9. Issued on 30 December 2009, it has applied since 1 June 2011.

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Document preview — YY/T 0511-2009

National Standard of the People's Republic of China

ICS: 11.100

Issued by: National Medical Products Administration of the People's Republic of China

1 Foreword

YY/T 0511-2009 was issued by National Medical Products Administration of the People's Republic of China on 30 December 2009 and has been in force since 1 June 2011.

2 Scope

This standard is a recommended Chinese medical device standard giving a test method for evaluating the biodegradation and the osteogenesis of porous bioceramics in vivo. It covers the qualitative and quantitative assessment of how the material degrades once implanted in bone tissue and of the bone formation that follows. Degradation is judged from the decomposition reaction produced in the bone tissue, and osteogenesis from the degree of new bone formed. The method is written for porous bioceramics implanted in bone without regard to any mechanical or functional load on them. It quotes GB/T 16886.1, GB/T 16886.2, GB/T 16886.6 and GB/T 16886.9.

3 Normative references

YY/T 0511-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.

GB/T 16886.1

GB/T 16886.2

GB/T 16886.6

GB/T 16886.9

4 About this standard

Issued by: National Medical Products Administration of the People's Republic of China

English translation: about 15 pages

5 Classification and status

International classification (ICS): 11.100

Prefix YY/T: recommended standard.

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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.

Referenced standards

Normative references

Similar standards

GB/T 48011-2026

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