ISO 13958-2014 pdf free download

ISO 13958-2014 pdf free download.Concentrates for haemodialysis and related therapies
Concentrés pour hémodialyse et théra pies apparentées.
4 Requirements
4.1 Concentrates
4.1.1 Physical state
The concentrate for haemodialysis may be supplied in dry or aqueous form. Packaging may be for direct use with a single dialysis machine or for use in systems supplying multiple dialysis machines (bulk use).
4.1.2 Solute concentrations
4.1.2.1 Liquid solute concentrations
All electrolytes identified on the label shall be present within ±5 % or ±0,1 mEq/l (expressed as dialysis fluid concentrations), whichever is greater, of the stated concentration, with the exception of sodium, which shall be present within ±2,5 % of the labelled concentration, or shall be present according to approved specifications by the local regulations. If used, glucose shall be present within ±5% or ±0.05 g/l (when measured as properly diluted dialysis fluid), whichever is greater, of the labelled concentration, or shall be present according to approved specifications by the local regulations. Where concentrates include non-traditional constituents, such as antioxidants and iron compounds, these constituents shall be present at nominal concentrations with ±5 % tolerances, or shall be present according to approved specifications by the local regulations. If alternate, locally approved tolerances are used, the tolerances shall be similarly stated and the rationale for their use documented.
Most concentrates are manufactured with standard traditional chemicals such as sodium chloride, potassium chloride, magnesium chloride, calcium chloride, acetic acid, glucose. etc. New concentrates are available in which certain chemicals have been substituted by others; for example, citric acid has been substituted for acetic acid. Where this occurs, the labelling shall correctly reflect this and the substitute chemicals shall be present at nominal concentrations with ±5% tolerances, or shall be present according to approved specifications by the local regulations. If alternate, locally approved tolerances are used, the tolerances shall be similarly stated and the rationale for their use documented.
4.1.2.2 Solute concentrations from powder
When concentrate is packaged in dry form or a combination of dry and liquid and is mixed according to the manufacturer’s instruction for use, the final concentrate shall meet the requirements of 4.L2.1.
4.1.3 Water
The quality of water used in the manufacture of the concentrate shall be in accordance with ISO 13959.ISO 13958-2014 pdf free download.