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Overview EN ISO 8637-2:2024 (adopted by CEN) specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used with haemodialysis equipment for extracorporeal blood t…
Overview EN ISO 8637-1:2020 (ISO 8637-1:2017) covers requirements for extracorporeal blood purification devices used in humans: haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. P…
What is ISO 8637 ‑ 1 about? ISO 8637 discusses extracorporeal systems for blood purification. ISO 8637 ‑ 1 outlines requirements for haemodialyser, haemodiafilter, haemofilter, and haem concentrators…
1 Scope This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters . Only those requirements that are specific to plasmafilt…
1 Scope This International Standard specifies requirements for haemodialysers , haemodiafilters , haemofilters and haemoconcentrators , hereinafter collectively referred to as “the device”, for use i…
1 Scope WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document. This document specifies requirements for the blood circuit fo…
Overview ISO 8637-3:2024 - Extracorporeal systems for blood purification - Part 3: Plasmafilters - specifies requirements and test methods for sterile, single‑use plasmafilters used to separate plasm…
Overview ISO 8637-1:2024 - "Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators" specifies safety, performance and test requir…
Overview ISO 8637-2:2024 specifies safety and performance requirements for disposable extracorporeal blood and fluid circuits and associated accessories used with haemodialysis equipment for extracor…