| Standardization field | Health, environment and medical equipment |
|---|
| Technical committee | BAS/TC 25- Healthcare |
|---|
| Term (EN) | primary sample specimen |
|---|
| Definition (EN) | discrete portion of a body fluid or tissue or other sample associated with the human body taken for examination (3.8), study or analysis of one or more quantities or characteristics to determine the character of the whole
Note 1 to entry: The International Medical Device Regulators Forum (IMDRF) uses the term specimen in its harmonized guidance documents to mean a sample of biological origin intended for examination by a medical laboratory (3.20).
[SOURCE: ISO 18113-1:2022, 3.1.65, modified — Note 1 to entry has been modified. Note 2 to entry has been deleted.] |
|---|
| Term (FR) | |
|---|
| Definition (FR) | |
|---|
| Term (DE) | |
|---|
| Definition (DE) | |
|---|
| Term (BS) | primarni uzorak |
|---|
| Definition (BS) | odgovarajuća količina tjelesne tečnosti ili tkiva ili drugi uzorak iz ljudskog tijela uzet za ispitivanje (3.8), istraživanje ili analizu jedne ili više veličina ili karakteristika kako bi se odredio karakter cjeline
Napomena 1: Međunarodni forum regulatornih tijela za medicinska sredstva (IMDRF) koristi pojam uzorak u svojim harmoniziranim vodičima sa značenjem uzorka biološkog porijekla namijenjenog za ispitivanje od strane medicinskog laboratorija (3.20).
[IZVOR: ISO 18113-1:2022, 3.1.65, modificirana — Napomena 1 je modificirana. Napomena 2 je uklonjena.] |
|---|
| Term (HR) | |
|---|
| Definition (HR) | |
|---|
| Term (SR) | |
|---|
| Definition (SR) | |
|---|
| Date | 2025-01-13 |
|---|
| Standards | BAS EN ISO 15189:2025 |
|---|
