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DIN EN ISO 10993-5-2009

医疗器械的生物学评价 第5部分:体外细胞毒性试验

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

适用范围:This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.These methods specify the incubation of cultured cells in contact with a device and/or extracts of a deviceeither directly or through diffusion.These methods are designed to determine the biological response of mammalian cells in vitro usingappropriate biological parameters.

实施日期: 2009-10-01

中标分类号: C30 - 医药、卫生、劳动保护 - 医疗器械综合

ICS分类号: 11.100.20 - 医药卫生技术

标准组织: DIN - 德国国家标准学会标准

全文来源: WF

英文关键词: Bioassay Biological analysis and testing Culture media Cytotoxicity Definitions Dental equipment Dental instruments Implants (surgical) In vitro In-vitro diagnostic Medical devices Medical equipment Medical products Medical sciences Surgical equipment Surgical implants Test methods Test procedures Testing

语种: 汉语

页数: 46

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