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Found: 18
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…
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…
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…
