O le fa'amama sa'o o masini fa'afoma'i e iai sona sao taua i le fa'amautinoaina o le saogalemu o tagata ma'i ma puipuia le sosolo o fa'ama'i.

O atunu'u 'ese'ese ma falema'i fa'alesoifua maloloina ua fa'atūina mana'oga fa'apitoa ma tulafono fa'atatau i le fa'amama fa'ama'i o masini manava manava.O lenei tusiga e faʻamoemoe e suʻesuʻe taʻiala ma tulaga faʻatulagaina e malo eseese, e taulaʻi i Saina ma isi atunuʻu atinaʻe.E ala i le malamalama i nei tulafono faatonutonu, e mafai e fomaʻi soifua maloloina ona faʻamautinoa le faʻamama lelei o faʻamaʻi manava ma tausia se tulaga maualuga o le tausiga o maʻi.

1. Tu'umamafa Manaoga i Saina

I totonu o Saina, o manaʻoga faʻamaʻi mo mea faʻafefe manava e faʻatonutonuina e le National Health Commission (NHC) ma le State Administration for Market Regulation (SAMR).O le "Taʻiala mo le Faʻamama i totonu o le Soifua Maloloina" na tuʻuina atu e le NHC o loʻo tuʻuina atu ai faʻamatalaga auiliili mo le faʻamaʻaina o mea faʻafomaʻi, e aofia ai ma masini manava.E tusa ai ma nei taʻiala, o le faʻamaʻi pipisi e tatau ona mulimulitaʻi i mataupu faavae o le maeʻa, aoga, ma le saogalemu.O lo'o fa'ama'oti mai fo'i i ta'iala ia fa'ama'i fa'ama'i fautuaina, taimi e fa'aalia ai, ma le fa'alelei lelei i le taimi o le fa'amamago.

E le gata i lea, o le SAMR o loʻo vaʻavaʻaia le faʻatinoina o tulaga faʻataʻitaʻiga e pei o le "Media Faʻafomaʻi - Faʻatonuga Tulaga Faʻatonu - Manaoga mo Faʻatonuga Faʻatonu" (YY / T 0287) ma le "Fomaʻi Faʻafomaʻi - Faʻaaogaina o le Faʻatonuina o Tulaga lamatia i Mea Faʻafomaʻi" (YY / T 0466.1 ).O nei tulaga fa'amautinoa e fa'amalieina le manava manava e mana'omia ma fa'amama lelei a'o le'i fa'aogaina.

2. Manaoga i le Iunaite Setete

I totonu o le Iunaite Setete, o le Food and Drug Administration (FDA) o loʻo tuʻuina atu taʻiala ma tulafono faʻatonutonu mo le faʻamaʻiina o masini manava manava.E tusa ai ma le FDA's "Guidance for Industry and FDA Staff - Processing Medical Devices in Health Care Settings: Validation Methods and Labeling," e tatau ona faia e ventilators manava se faiga toe faʻamaonia e mautinoa ai lo latou saogalemu ma le aoga.

E le gata i lea, o le Association for the Advancement of Medical Instrumentation (AAMI) o loʻo faʻasalalau tulaga faʻapitoa e pei o le "ANSI / AAMI ST79: 2017 - Taʻiala Maualalo i le Faʻamaʻaina o le Ausa ma Faʻamautinoaga Faʻamaʻi i Fale Tausiga Soifua Maloloina."O lenei tulaga o loʻo faʻamatalaina ai faiga sili ona lelei mo le faʻamama ma le faʻamaʻaina o mea faʻafomaʻi, e aofia ai le manava manava, e puipuia ai faʻamaʻi pipisi e fesoʻotaʻi ma le soifua maloloina.

3. Manaoga Europa

I totonu o Europa, o manaʻoga faʻamaʻi mo manava manava e faʻatonutonuina e le Komiti Europa mo Faʻasalalauga (CEN) ma le European Medicines Agency (EMA).Ua fausia e le CEN le tulaga masani "EN ISO 17664: 2017 - Faʻamaʻaina o Mea Faʻafomaʻi - Faʻamatalaga e tuʻuina atu e le Faumea mo le Faʻagasologa o Mea Faʻafomaʻi Faʻafomaʻi" e taʻitaʻia ai le au gaosi oloa i le tuʻuina atu o faʻatonuga mo le faʻamaʻiina o masini faʻafomaʻi.

E le gata i lea, o le EMA o loʻo tuʻuina atu taʻiala ma tulafono faʻatonutonu mo le faʻamaʻiina o masini faʻafomaʻi, e aofia ai manava manava.O le "Taʻiala ile Tulaga Lelei, Saogalemu, ma le Lelei o Mea Faʻafomaʻi" na tuʻuina atu e le EMA o loʻo faʻamamafaina ai le taua o faiga faʻamaʻi lelei e faʻamautinoa ai le saogalemu o tagata maʻi ma le aoga o masini.

O mana'oga fa'ama'i fa'ama'i ma fa'atonuga mo fa'amama fa'amama e 'ese'ese i atunu'u 'ese'ese, e atagia ai le ta'utinoga fa'ava-o-malo i le saogalemu o tagata ma'i ma le fa'atonutonuina o fa'ama'i.I Saina, o le National Health Commission ma le State Administration for Market Regulation o loʻo tuʻuina atu taʻiala ma faʻataʻitaʻiga mo le faʻamaʻiina o mea faʻafomaʻi, e aofia ai le manava manava.I totonu o le Iunaite Setete, o le Food and Drug Administration ma le Association for the Advancement of Medical Instrumentation o loʻo faia ni matafaioi taua i le faʻavaeina o taʻiala ma tulaga.I totonu o Europa, o le European Committee for Standardization ma le European Medicines Agency e faʻamautinoa le saogalemu ma le aoga o masini faʻafomaʻi e ala ia latou tulafono faatonutonu.

E ala i le tausisia o nei manaʻoga ma tulafono faatonutonu, e mafai e fomaʻi soifua maloloina ona tausia se siosiomaga saogalemu ma le le lelei, faʻaitiitia le lamatiaga o faʻamaʻi pipisi e fesoʻotaʻi ma le soifua maloloina, ma faʻamautinoa le lelei o le faʻaogaina o masini manava.E taua tele mo nofoaga fa'alesoifua maloloina le fa'afou fa'atasi ma ta'iala ma fa'ata'ita'iga fou e tu'uina atu ai le tausiga sili i tagata mama'i.

Manatua, o faiga fa'amama sa'o e le gata e puipuia ai ma'i ae e saofagā fo'i i le manuia lautele o faiga fa'alesoifua maloloina i le lalolagi atoa.