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Item 3.4.5
Fizioloģiskā šķīduma skalošanas šļirce:
1) tilpums - 10 ml,
2) sterila,
3) piemērota IV katetru un IV kaniļu skalošanai sterilā vidē,
4) pildīta ar sterilu 10 ml NaCl 0,9% šķīdumu,
5) kopējā osmolārā koncentrācija ne vairāk kā 0.31 mOsm/ml,
6) pH no 4.5 līdz 7.
Parsed Requirements (8)
| Attribute | Type | Operator | Value | Unit | Source Text |
| osmolarity |
numeric |
<= |
0.31
|
mOsm/ml |
osmolārā koncentrācija ne vairāk kā 0.31 mOsm/ml |
| volume |
numeric |
= |
10.0
|
ml |
tilpums - 10 ml |
| ph |
range |
range |
4.5 – 7.0
|
|
pH no 4.5 līdz 7. |
| nacl_concentration |
numeric |
= |
0.9
|
% |
NaCl 0,9% |
| sterile |
boolean |
= |
True
|
|
sterila |
| formulation |
categorical |
= |
syringe
|
|
šļirc |
| device_type |
categorical |
= |
syringe
|
|
šļirce |
| route |
categorical |
= |
enteral
|
|
|
Pass: 4
Fail: 0
Unknown: 4
Confidence: 0.5
| Attribute | Status | Product Value | Required | Reason |
| osmolarity |
UNKNOWN
|
N/A |
<= 0.31 mOsm/ml |
Product has no value for 'osmolarity' |
| volume |
PASS
|
10.0 ml |
= 10.0 ml |
|
| ph |
UNKNOWN
|
N/A |
4.5-7.0 |
Product has no value for 'ph' |
| nacl_concentration |
UNKNOWN
|
N/A |
= 0.9 % |
Product has no value for 'nacl_concentration' |
| sterile |
PASS
|
True |
True |
|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 3
Fail: 0
Unknown: 5
Confidence: 0.375
| Attribute | Status | Product Value | Required | Reason |
| osmolarity |
UNKNOWN
|
N/A |
<= 0.31 mOsm/ml |
Product has no value for 'osmolarity' |
| volume |
UNKNOWN
|
N/A |
= 10.0 ml |
Product has no package size |
| ph |
UNKNOWN
|
N/A |
4.5-7.0 |
Product has no value for 'ph' |
| nacl_concentration |
UNKNOWN
|
N/A |
= 0.9 % |
Product has no value for 'nacl_concentration' |
| sterile |
PASS
|
True |
True |
|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 3
Fail: 0
Unknown: 5
Confidence: 0.375
| Attribute | Status | Product Value | Required | Reason |
| osmolarity |
UNKNOWN
|
N/A |
<= 0.31 mOsm/ml |
Product has no value for 'osmolarity' |
| volume |
UNKNOWN
|
N/A |
= 10.0 ml |
Product has no package size |
| ph |
UNKNOWN
|
N/A |
4.5-7.0 |
Product has no value for 'ph' |
| nacl_concentration |
UNKNOWN
|
N/A |
= 0.9 % |
Product has no value for 'nacl_concentration' |
| sterile |
PASS
|
True |
True |
|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 3
Fail: 1
Unknown: 4
Confidence: 0.375
| Attribute | Status | Product Value | Required | Reason |
| osmolarity |
UNKNOWN
|
N/A |
<= 0.31 mOsm/ml |
Product has no value for 'osmolarity' |
| volume |
FAIL
|
1.0 ml |
= 10.0 ml |
1.0 ml != 10.0 ml |
| ph |
UNKNOWN
|
N/A |
4.5-7.0 |
Product has no value for 'ph' |
| nacl_concentration |
UNKNOWN
|
N/A |
= 0.9 % |
Product has no value for 'nacl_concentration' |
| sterile |
PASS
|
True |
True |
|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 3
Fail: 1
Unknown: 4
Confidence: 0.375
| Attribute | Status | Product Value | Required | Reason |
| osmolarity |
UNKNOWN
|
N/A |
<= 0.31 mOsm/ml |
Product has no value for 'osmolarity' |
| volume |
FAIL
|
5.0 ml |
= 10.0 ml |
5.0 ml != 10.0 ml |
| ph |
UNKNOWN
|
N/A |
4.5-7.0 |
Product has no value for 'ph' |
| nacl_concentration |
UNKNOWN
|
N/A |
= 0.9 % |
Product has no value for 'nacl_concentration' |
| sterile |
PASS
|
True |
True |
|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| route |
PASS
|
enteral |
enteral |
|
Pass: 3
Fail: 1
Unknown: 4
Confidence: 0.375
| Attribute | Status | Product Value | Required | Reason |
| osmolarity |
UNKNOWN
|
N/A |
<= 0.31 mOsm/ml |
Product has no value for 'osmolarity' |
| volume |
FAIL
|
20.0 ml |
= 10.0 ml |
20.0 ml != 10.0 ml |
| ph |
UNKNOWN
|
N/A |
4.5-7.0 |
Product has no value for 'ph' |
| nacl_concentration |
UNKNOWN
|
N/A |
= 0.9 % |
Product has no value for 'nacl_concentration' |
| sterile |
PASS
|
True |
True |
|
| formulation |
UNKNOWN
|
N/A |
syringe |
Catalogue does not state 'formulation' for this product |
| device_type |
PASS
|
syringe |
syringe |
|
| route |
PASS
|
enteral |
enteral |
|