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Item 3.4.21

Sterils bez adatas vārsts/savienotājs ar pašnoslēgšanās darbības principu un mērķi aizsardzībai pret inficēšanās risku un šķīduma nejaušu noplūdi injekciju un infūziju ievades laikā, kā arī novērš risku personālam tikt savainotam ar adatu, kas paredzēts savienošanai gan ar luer-slip, gan ar luer-lock tipa šļircēm, perifēro un centrālo vēnu katetriem, kā arī dažāda veida infūzijas un transfūzijas sistēmām. Raksturojošie parametri: 1) Bez adatas vārstu veido caurspīdīgs apvalks ar caurspīdīgo silikona virzuli iekšpusē un „luer lock” tipa baltu poliuretāna savienojuma daļu. 2) Bez adatas vārstu veidojošās daļas nesatur metālu un lateksu, var izmantot magnētiskās rezonanses izmeklējumu laikā. 3) Izturīgs pret spirtu, hlorheksidīnu un lipīdu šķīdumiem. Ķīmiski noturīgs pret tādām vielām kā Taxol un Vancomycin. 4) Nepieciešamais vārsta uzpildes tilpums - ne vairāk kā 0,22 ml. 5) Vidējais gravitācijas plūsmas ātrums ne mazāks kā 7740 ml/stundā. 6) Bez adatas vārsta maksimālais pieļaujamais izmantošanas laiks vienam un tam pašam pacientam ir līdz 7 dienām vai 1000 aktivēšanas reizēm. 7) Katram bez adatas vārstam ir jābūt iepakotam atsevišķā, sterilā iepakojumā ar norādītu derīguma beigu termiņu un atzīmi par CE marķējumu.

Parsed Requirements (7)

AttributeTypeOperatorValueUnitSource Text
volume numeric <= 0.22 ml tilpums - ne vairāk kā 0,22 ml
sterile boolean = True Sterils
formulation categorical = solution šķīdum
device_type categorical = syringe šļircēm
material categorical = polyurethane poliuretāna
latex_free boolean = True lateksu
route categorical = enteral

Product Matches (6)

Hide Non-Compliant

#1 Compat® ENject Enteral Syringe 1mL Low Dose Tip Compat ENject Enteral Syringe

PARTIAL View Product
Pass: 5 Fail: 0 Unknown: 2 Confidence: 0.714
AttributeStatusProduct ValueRequiredReason
volume PASS 1.0 ml = 0.22 ml
sterile PASS True True
formulation UNKNOWN N/A solution Catalogue does not state 'formulation' for this product
device_type PASS syringe syringe
material UNKNOWN N/A = polyurethane Catalogue does not state 'material' for this product
latex_free PASS True True
route PASS enteral enteral

#2 Compat® ENject Enteral Syringe 2.5-3mL Low Dose Tip Compat ENject Enteral Syringe

UNKNOWN View Product
Pass: 4 Fail: 0 Unknown: 3 Confidence: 0.571
AttributeStatusProduct ValueRequiredReason
volume UNKNOWN N/A <= 0.22 ml Product has no package size
sterile PASS True True
formulation UNKNOWN N/A solution Catalogue does not state 'formulation' for this product
device_type PASS syringe syringe
material UNKNOWN N/A = polyurethane Catalogue does not state 'material' for this product
latex_free PASS True True
route PASS enteral enteral

#3 Compat® ENject Enteral Syringe 50-60mL Compat ENject Enteral Syringe

UNKNOWN View Product
Pass: 4 Fail: 0 Unknown: 3 Confidence: 0.571
AttributeStatusProduct ValueRequiredReason
volume UNKNOWN N/A <= 0.22 ml Product has no package size
sterile PASS True True
formulation UNKNOWN N/A solution Catalogue does not state 'formulation' for this product
device_type PASS syringe syringe
material UNKNOWN N/A = polyurethane Catalogue does not state 'material' for this product
latex_free PASS True True
route PASS enteral enteral

#4 Compat® ENject Enteral Syringe 5mL Low Dose Tip Compat ENject Enteral Syringe

NON-COMPLIANT View Product
Pass: 4 Fail: 1 Unknown: 2 Confidence: 0.571
AttributeStatusProduct ValueRequiredReason
volume FAIL 5.0 ml = 0.22 ml 5.0 ml != 0.22 ml
sterile PASS True True
formulation UNKNOWN N/A solution Catalogue does not state 'formulation' for this product
device_type PASS syringe syringe
material UNKNOWN N/A = polyurethane Catalogue does not state 'material' for this product
latex_free PASS True True
route PASS enteral enteral

#5 Compat® ENject Enteral Syringe 10mL Compat ENject Enteral Syringe

NON-COMPLIANT View Product
Pass: 4 Fail: 1 Unknown: 2 Confidence: 0.571
AttributeStatusProduct ValueRequiredReason
volume FAIL 10.0 ml = 0.22 ml 10.0 ml != 0.22 ml
sterile PASS True True
formulation UNKNOWN N/A solution Catalogue does not state 'formulation' for this product
device_type PASS syringe syringe
material UNKNOWN N/A = polyurethane Catalogue does not state 'material' for this product
latex_free PASS True True
route PASS enteral enteral

#6 Compat® ENject Enteral Syringe 20mL Compat ENject Enteral Syringe

NON-COMPLIANT View Product
Pass: 4 Fail: 1 Unknown: 2 Confidence: 0.571
AttributeStatusProduct ValueRequiredReason
volume FAIL 20.0 ml = 0.22 ml 20.0 ml != 0.22 ml
sterile PASS True True
formulation UNKNOWN N/A solution Catalogue does not state 'formulation' for this product
device_type PASS syringe syringe
material UNKNOWN N/A = polyurethane Catalogue does not state 'material' for this product
latex_free PASS True True
route PASS enteral enteral