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YY/T 0127.9-2009Biological Evaluation of Medical Devices Used in Dentistry - Part 2: Test Method - Cytotoxicity Tests: Agar Diffusion Test and Filter Diffusion Test (English PDF)

口腔医疗器械生物学评价第 2 单元: 试验方法细胞毒性试验：琼脂扩散法及滤膜扩散

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 1, 2009

Implementation date

June 1, 2011

Scope

YY/T 0127.9-2009 is the English-translated version of 口腔医疗器械生物学评价第 2 单元: 试验方法细胞毒性试验：琼脂扩散法及滤膜扩散.

YY/T 0127.9-2009 is the Chinese standard "Biological Evaluation of Medical Devices Used in Dentistry - Part 2: Test Method - Cytotoxicity Tests: Agar Diffusion Test and Filter Diffusion Test".

Its scope clause reads: This standard specifies the test method for cytotoxicity of medical devices used in dentistry: agar diffusion test and filter diffusion test.

This test is designed to demonstrate the nonspecific cytotoxicity of medical devices used in dentistry after diffuse through agar or agarose or after diffusion through a cellulose acetate filter.

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Document preview — YY/T 0127.9-2009

National Standard of the People's Republic of China

ICS: 11.060.10
Replacing: YY/T 0127.9-2001

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

1 Scope
2 Normative References
3 Agar Diffusion Test
4 Filter Diffusion Test
Appendix A (Informative)
Appendix B (Informative)

1 Scope

This standard specifies the test method for cytotoxicity of medical devices used in dentistry: agar diffusion test and filter diffusion test.

This test is designed to demonstrate the nonspecific cytotoxicity of medical devices used in dentistry after diffuse through agar or agarose or after diffusion through a cellulose acetate filter.

2 Normative References

The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For the dated references, the subsequent amendments to (excluding amending error in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of these documents is applicable. For the undated references, the latest edition of the normative document is applicable to this 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

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YY/T 0127.18-2016|YY/T 0993-2015|GB/T 16886.5-2017|YY/T 1670.2-2025|YY/T 0127.19-2023|YY/T 0127.4-2023

Editions of YY/T 0127.9

Edition	Title	Revision	Status
YY/T 0127.9-2009	Biological Evaluation of Medical Devices Used in Dentistry - Part 2: Test Method - Cytotoxicity Tests: Agar Diffusion Test and Filter Diffusion Test	current edition	Current
YY/T 0127.9-2001	Biological Evaluation of Medical Devices Used in Dentistry - Part 2: Test Method - Cytotoxicity Tests: Agar Diffusion Test and Filter Diffusion Test	previous edition	Superseded

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