Port | Huanghua port |
Packaging | plastic film&plastic pallets |
Lead Time | Within two weeks |
Has been committed to ultra clean dialysate barrel!
Dialysate barrel specifications
Volume | Weight | Dimensions | Color | |||
( L ) | g | Maximum Diameter | Height | mouth diameter | ||
5 | 280±10 | 194×162±3 | 250±3 | 44±0.3 | White |
☆The barrel and lid materials meet the biocompatibility requirements of China and the world (ISO 10993 series or GB/T 16886 series) to avoid toxin contamination of the concentrate and ensure the safety of patient dialysis treatment
☆Microbial pollution control: the total number of aerobic
bacteria shall not exceed 50CFU/barrel, the total number of mold
and yeast shall not exceed 50CFU/barrel, and Escherichia coli,
Staphylococcus aureus and Pseudomonas aeruginosa shall not be
detected
☆Particle control: ≥ 10 μ No more than 6 particles/ml of m; ≥
twenty-five μ No more than 1 particle/ml of m
test | Reference standards |
Cytotoxicity assays | ISO 10993-5:2009(E) |
sensitization test | ISO 10993-10:2010(E) |
intradermal reaction | 10993-10:2010(E) |
systemic acute toxicity | ISO 10993-11:2017(E) |
blood-compatibility | ASTM F756 |
Thermal-conductivity | Chienese pharmacopoeia volume IV <1142> |
USP<151> | |
chemical characterization |
ISO 10993-18:2020(E) |