标准编号：ISO 8637-3:2018
中文名称：血液净化体外系统 第3部分：血浆过滤器
英文名称：Extracorporeal systems for blood purification — Part 3: Plasmafilters
发布日期：2018-07
标准范围
This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
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