Imashini yacu yo gusesengura A101 yamaze kwemererwa na IVDR.

Ubu yemewe n'isoko ry'i Burayi. Dufite kandi icyemezo cya CE ku bikoresho byacu byo gupima byihuse.

Ihame ry'umuti wa A101:

1. Hamwe n'uburyo bwo gupima bugezweho, uburyo bwo gupima amashanyarazi n'uburyo bwo gusuzuma ubudahangarwa bw'umubiri, WIZ Sisitemu yo gusesengura irashobora gukoreshwa mu gupima ubuziranenge n'ubunini.

2.WIZ-Sisitemu yo gusesengura ikwiriye uburyo bwo gupima butandukanye nka colloidal gold, latex na fluorescence analysis.

3. Ikwiriye ingero zitandukanye zo gupima (amaraso yose, plasma, serum cyangwa inkari nibindi) kandi ni urubuga rwo gupima no gusesengura rujyanye nayo.

4. Imiterere y'ipatanti yagenewe guhuza n'igihe gitandukanye cyo kuyimenya no kuyigaragaza mu buryo buhoraho.

Ikiranga:

1.ubuhanga bwo kuvura cyane

2. Iragendanwa, ikwiriye ibitaro by'abaturage, POCT, ishami ry'ivuriro, ubutabazi bwihutirwa, ivuriro, serivisi yihutirwa, ICU, Ishami ry'abarwayi bataha, n'ibindi

3. Guhuza amahame n'imishinga itandukanye yo gupima (colloidal gold, latex na fluorescence)

4. Guhuza ibikoresho bitandukanye byo gupima, ubwoko butandukanye bw'ibipimo (amaraso yose, plasma cyangwa inkari) n'igihe gitandukanye cyo kubipima

5. guhuza uburyo bwo gusobanura no kwirinda ikosa ryo mu maso gusa

6. Uburyo busanzwe bwo kumenya intambwe eshatu, amakuru y'icyitegererezo n'ibisubizo by'ikizamini bihura kimwe kimwe, bihuza sisitemu ya LIS mu buryo bwikora, ibisubizo bihita bishyirwa ku rubuga.

Twandikire niba ufite inyungu ku rubuga rwacuIsesengura rya A101.Ibindi bisobanuro ukeneye, turakwinginze uduhamagare igihe icyo ari cyo cyose.