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.
Document identifier
ISO 8637-3:2018
Title
Extracorporeal systems for blood purification - Part 3: Plasmafilters
ISO Category
TC 150/SC 2: Cardiovascular implants and extracorporeal systems
Publication date
2018-07-01
International Relationship
BS ISO 8637-3:2018
History of version
ISO 8637-3:2018 * ISO 13960:2010 * ISO 13960:2003
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103 vnd |
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