BS ISO 8637-3:2018
Current
The latest, up-to-date edition.
Extracorporeal systems for blood purification Plasmafilters
Hardcopy , PDF
English
20-07-2018
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 ISO10993.
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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