Standard No.:	YY/T 0127.9-2009
English Name:	Biological Evaluation of Medical Devices Used in Dentistry - Part 2：Test Method - Cytotoxicity Tests: Agar Diffusion Test and Filter Diffusion Test
Chinese Name:	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
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	SFDA
Issued on:	2009-12-1
Implemented on:	2011-6-1
Status:	valid
Superseding:	YY/T 0127.9-2001 Biological evaluation of dental materials―Part 2:Biological evaluation test method of dental materials―Cytotoxicity tests:Agar diffusion test and filter dissusion test
Target Language:	English
File Format:	PDF
Word Count:	4500 words
Translation Price(USD):	90.0
Delivery:	via email in 1 business day

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.

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