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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 (3)
| Attribute | Type | Operator | Value | Unit | Source Text |
| volume |
numeric |
<= |
0.22
|
ml |
tilpums - ne vairāk kā 0,22 ml |
| sterile |
boolean |
= |
True
|
|
Sterils |
| formulation |
categorical |
= |
syringe
|
|
šļirc |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
1000.0 ml |
= 0.22 ml |
1000.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
1000.0 ml |
= 0.22 ml |
1000.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
90.0 ml |
= 0.22 ml |
90.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
500.0 ml |
= 0.22 ml |
500.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
237.0 ml |
= 0.22 ml |
237.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
237.0 ml |
= 0.22 ml |
237.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 2
Unknown: 1
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
FAIL
|
200.0 ml |
= 0.22 ml |
200.0 ml != 0.22 ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
liquid |
syringe |
'liquid' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
100.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |
Pass: 0
Fail: 1
Unknown: 2
Confidence: 0.0
| Attribute | Status | Product Value | Required | Reason |
| volume |
UNKNOWN
|
400.0 g |
<= 0.22 ml |
Not comparable: product in g, requirement in ml |
| sterile |
UNKNOWN
|
N/A |
True |
Cannot determine 'sterile' for this product |
| formulation |
FAIL
|
powder |
syringe |
'powder' != 'syringe' |