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ISO 8637-3:2018
Extracorporeal systems for blood purification — Part 3: Plasmafilters
Translate name
STANDARD published on 17.7.2018
The information about the standard:
Designation standards: ISO 8637-3:2018
Publication date standards: 17.7.2018
SKU: NS-854971
The number of pages: 14
Approximate weight : 42 g (0.09 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
Annotation of standard text ISO 8637-3:2018 :
Description / Abstract: 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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