Catalog of standards
Catalog of standards | Reference number of the normative document | Title of the normative document | Status | Developer of the normative document and its address | Price in Armenian drams (AMD) (including VAT) |
Cart |
| GOST ISO 15197-2011 | In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus | Active |
|
10400 |
Russian |
| AST GOST R EN 12322-2023 | In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media | Active |
|
2800 |
Russian |
| AST GOST R EN 13532-2023 | General requirements for in vitro diagnostic medical devices for self-testing | Active |
|
2800 |
Russian |
| AST GOST R EN 13612-2023 | Performance evaluation of in vitro diagnostic medical devices | Active |
|
3200 |
Russian |
| AST GOST R EN 13641-2023 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents | Active |
|
2400 |
Russian |
| AST GOST R EN 14254-2023 | In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans | Active |
|
5600 |
Russian |
| AST ISO 15193-2018 | In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures | Active |
|
29500 |
Armenian |
| AST ISO 15194-2018 | In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation | Active |
National Institute of Standards CJSV (Yerevan) 2004 c. Yrevan, Komitas str. 49/4 |
22000 |
Armenian |
| AST ISO 15198-2013 | Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer | Active |
National Institute of Standards CJSV (Yerevan) 2004 c. Yrevan, Komitas str. 49/4 |
14500 |
Armenian |
| AST ISO 18113-1-2019 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements | Active |
National Institute of Standards CJSV (Yerevan) 2004 c. Yrevan, Komitas str. 49/4 |
40000 |
Armenian |
| AST ISO 18113-2-2019 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) . Part 2: In vitro diagnostic reagents for professional use | Active |
|
14500 |
Armenian |
| AST ISO 18113-3-2019 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use | Active |
|
14500 |
Armenian |
| AST ISO 18113-4-2019 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing | Active |
|
14500 |
Armenian |
| AST ISO 18113-5-2019 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing | Active |
|
14500 |
Armenian |
| GOST ISO 18153-2011 | In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials | Active |
|
4400 |
Russian |
| AST GOST R ISO 23640-2023 | In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents | Active |
|
2800 |
Russian |
