GSO ISO 10993-4:2016

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

GSO ISO 10993-4:2016 发布历史

GSO ISO 10993-4:2016由GSO 发布于 2016-12-22。

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GSO ISO 10993-4:2016 的最新版本是哪一版？

最新版本是 GSO ISO 10993-4:2016 。

GSO ISO 10993-4:2016的历代版本如下：

• 2016年 GSO ISO 10993-4:2016

This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes a) 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 tests for interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

标准号

GSO ISO 10993-4:2016

发布

2016年

发布单位

GSO

当前最新

GSO ISO 10993-4:2016

 

 

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