医疗器械的生物学评价第4部分:与血液相互作用的试验选择

DIN EN ISO 10993-4-2009

医疗器械的生物学评价第4部分:与血液相互作用的试验选择

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

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适用范围：This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.It describesa) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,b) the fundamental principles governing the evaluation of the interaction of devices with blood,c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of testsfor interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms andmay not necessarily provide sufficient guidance for test methods for a specific device.

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 Biological hazards Biological tests Blood Classification Definitions Dental equipment Dental instruments Dentistry Evaluations Guidelines Haematology Implants (surgical) In vitro Interaction Materials Medical devices Medical equipment Medical products Medical sciences Risk Specification (approval) Surgical equipment Surgical implants Testing

语种：汉语

页数： 50

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医疗器械的生物学评价 第4部分:与血液相互作用的试验选择

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医疗器械的生物学评价第4部分:与血液相互作用的试验选择