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Valid from 05.07.2026

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This ISO 8637-3 2024 vs 2018 comparison helps manufacturers and regulatory teams quickly identify what has changed in the requirements and test methods for plasmafilters. Our gap analysis breaks down clause-by-clause revisions, so your team can update device documentation and validation processes without re-reading the entire standard. This standard specifies requirements and test methods for plasmafilters — devices intended to separate plasma from blood during therapeutic plasmapheresis therapy. It covers sterile, single-use plasmafilters intended for use on humans, referred to collectively as "the device." The standard does not apply to: Extracorporeal blood circuits Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Haemoperfusion devices Vascular access devices Blood pumps Systems or equipment intended to perform plasma separation Whether you're updating a Design History File, preparing regulatory submissions, or responding to a notified body query, this ISO 8637-3 2024 vs 2018 report gives you a clear, audit-ready summary of exactly what's changed between the two revisions.