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Valid from 05.07.2026

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This ISO 8637-1 2024 vs 2017 comparison helps manufacturers and regulatory teams quickly identify what has changed in the requirements and test methods for haemodialysers, haemodiafilters, haemofilters, and haemoconcentrators. 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 haemodialysers, haemodiafilters, haemofilters, and haemoconcentrators — referred to collectively as "the device" — intended for use in humans. The standard does not apply to: Extracorporeal blood circuits Plasmafilters Haemoperfusion devices Vascular access devices Blood pumps Systems to prepare, maintain, or monitor dialysis fluid Systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration, or haemoconcentration Reprocessing procedures and equipment Whether you're updating a Design History File, preparing regulatory submissions, or responding to a notified body query, this ISO 8637-1 2024 vs 2017 report gives you a clear, audit-ready summary of exactly what's changed between the two revisions.