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Item 3.4.4
Zema spiediena pilnšļirce:
1) pildījums - nātrija hlorīds 0,9% -10ml (QC002, SAL 10-6);
2) trīsdaļīga polipropilēna pilnšļirce, ar aizsarguzgali, kas pilnībā nosedz Luer Lock tipa skrūvējamu šļirces uzgali;
3) šļirces materiāls caurspīdīgs, nesatur PVC, DEHP un lateksu;
4) atbilst 7886-1 DIN EN ISO prasībām;
5) minimāls šļirces radītais reflukss.
Parsed Requirements (6)
| Attribute | Type | Operator | Value | Unit | Source Text |
|---|
| formulation |
categorical |
= |
syringe
|
|
šļirc |
| device_type |
categorical |
= |
syringe
|
|
šļirce |
| material |
categorical |
= |
polypropylene
|
|
polipropilēna |
| latex_free |
boolean |
= |
True
|
|
lateksu |
| dehp_free |
boolean |
= |
True
|
|
DEHP |
| route |
categorical |
= |
enteral
|
|
|
Pass: 4
Fail: 0
Unknown: 2
Confidence: 0.667
| Attribute | Status | Product Value | Required | Reason |
|---|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| material |
UNKNOWN
|
N/A |
= polypropylene |
Catalogue does not state 'material' for this product |
| latex_free |
PASS
|
True |
True |
|
| dehp_free |
PASS
|
True |
True |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 4
Fail: 0
Unknown: 2
Confidence: 0.667
| Attribute | Status | Product Value | Required | Reason |
|---|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| material |
UNKNOWN
|
N/A |
= polypropylene |
Catalogue does not state 'material' for this product |
| latex_free |
PASS
|
True |
True |
|
| dehp_free |
PASS
|
True |
True |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 4
Fail: 0
Unknown: 2
Confidence: 0.667
| Attribute | Status | Product Value | Required | Reason |
|---|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| material |
UNKNOWN
|
N/A |
= polypropylene |
Catalogue does not state 'material' for this product |
| latex_free |
PASS
|
True |
True |
|
| dehp_free |
PASS
|
True |
True |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 4
Fail: 0
Unknown: 2
Confidence: 0.667
| Attribute | Status | Product Value | Required | Reason |
|---|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| material |
UNKNOWN
|
N/A |
= polypropylene |
Catalogue does not state 'material' for this product |
| latex_free |
PASS
|
True |
True |
|
| dehp_free |
PASS
|
True |
True |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 4
Fail: 0
Unknown: 2
Confidence: 0.667
| Attribute | Status | Product Value | Required | Reason |
|---|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| material |
UNKNOWN
|
N/A |
= polypropylene |
Catalogue does not state 'material' for this product |
| latex_free |
PASS
|
True |
True |
|
| dehp_free |
PASS
|
True |
True |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 4
Fail: 0
Unknown: 2
Confidence: 0.667
| Attribute | Status | Product Value | Required | Reason |
|---|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| material |
UNKNOWN
|
N/A |
= polypropylene |
Catalogue does not state 'material' for this product |
| latex_free |
PASS
|
True |
True |
|
| dehp_free |
PASS
|
True |
True |
|
| route |
PASS
|
enteral |
enteral |
|