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DIN EN IEC 60601-2-16 VDE 0750-2-16:2026-02

Medical electrical equipment

Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

(IEC 60601-2-16:2025); German version EN IEC 60601-2-16:2025
Class/Status: Standard, valid
Released: 2026-02
VDE Art. No.: 0701648

Note: You can pre-order this document (delivery subject to availability). Valid from 2026-02-01.

This part of IEC 60601 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment, hereafter referred to as haemodialysis equipment. It applies to haemodialysis equipment intended for use either by medical staff or under the supervision of medical experts, including haemodialysis equipment operated by the PATIENT, regardless of whether the haemodialysis equipment is used in a hospital or domestic environment.