Haemodialysis equipment

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Haemodialysis equipment
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	Automatic standby mode	Core	Technical specification
Criterion information The energy consumption is reduced when the equipment automatically turns on standby mode or shuts down after a period of inactivity. Criterion text The equipment must have a function that automatically turn on standby mode or shut down after a period of inactivity, or according to a predetermined schedule.
	Water usage for haemodialysis equipment	Core	Award criteria
Criterion information This criterion awards the equipment with the lowest water use. Around 500 litres of water can be used for one dialysis treatment of one patient. Criterion text Points will be awarded according to the water usage in litres per treatment, The treatment cycle shall be as follows, in accordance with IEC 60601-2-16:2018 or equivalent: Test - time duration depends on machine Filling/Rinsing - 10 Minutes Pre-Circulation - 15 Minutes Dialysis- 4h The lower water consumption will be given more points. The testing shall be performed according to the general requirements in EN ISO 17025, U.S. 21 CFR del 820, ISO 13485 or equivalent.
	Reduction of the dialysis fluid flow rate	Core	Award criteria
Criterion information A lower dialysis fluid flow rate saves water, electricity, and dialysis concentrate. Criterion text Points will be awarded for dialysis equipment equipped with an automatic function to reduce the dialysis fluid flow during the time between pre-circulation and dialysis phase. The tenderer shall state the reduced dialysis flow.
	Bisphenol A in plastic	Core	Technical specification
Criterion information Bisphenol A is a suspected endocrine-disrupting substance with oestrogenic properties, risking damages of the human reproductive capacity. Criterion text Bisphenol A (CAS No. 80-05-7) shall not be added as a constituting element in membranes, filters or tubes. Impurities/residues shall not be present in amounts over 0.01% by weight in each individual part of the product.