Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
STANDARD published on 1.7.2025
Designation standards: ČSN EN IEC 60601-2-16-ed.4
Classification mark: 364801
Catalog number: 521375
Publication date standards: 1.7.2025
The number of pages: 112
Approximate weight : 367 g (0.81 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
This part of IEC 60601 applies to the basic safety and essential performance of haemodialysis, haemodiafil-tration and haemofiltration equipment, hereafter referred to as haemodialysis equipment. it applies to hae-modialysis 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 equip-ment is used in a hospital or domestic environment