Kunyatso uraya utachiona hwemaventilator mumidziyo yekurapa kunoita basa rakakosha mukuchengetedza kuchengetedzwa kwemurwere nekudzivirira kupararira kwehutachiona.

Nyika dzakasiyana uye maindasitiri ezvehutano akagadzira zvakati zvinodiwa uye mirau ine chekuita nekuuraya utachiona hwemafemu ekufema.Ichi chinyorwa chine chinangwa chekuongorora nhungamiro uye zviyero zvakatemerwa nenyika dzakasiyana siyana, zvichitarisa kuChina nedzimwe nyika dzakabudirira.Nekunzwisisa iyi mirau, vashandi vehutano vanogona kuve nechokwadi chekuuraya hutachiona hwekufema ventilator uye kuchengetedza mwero wepamusoro wekutarisirwa kwevarwere.

1. Disinfection Zvinodiwa muChina

MuChina, izvo zvinodikanwa zvekuuraya hutachiona zvekufema ventilator zvinodzorwa neNational Health Commission (NHC) uye State Administration for Market Regulation (SAMR).Iyo "Nhungamiro yeDisinfection in Healthcare Settings" yakapihwa neNHC inopa mirairo yakadzama yekuuraya utachiona michina yekurapa, kusanganisira yekufema.Zvinoenderana nemirairo iyi, nzira yekuuraya hutachiona inofanirwa kutevedzera misimboti yekunyatso, kushanda, uye kuchengetedza.Nhungamiro inotsanangurawo zvinokurudzirwa mishonga yekuuraya utachiona, nguva yekufumurwa, uye kufefetedza kwakaringana panguva yekuita disinfection.

Zvakare, iyo SAMR inoona nezvekuitwa kwezviyero zvakaita se "Medical Devices - Quality Management Systems - Zvinodiwa kune Regulatory Zvinangwa" (YY/T 0287) uye iyo "Medical Devices - Application yeRisk Management kune Medical Devices" (YY/T 0466.1 ).Aya mazinga anovimbisa kuti maventilator ekufema anosangana nemhando yezvinodiwa uye anoiswa disinfectant zvakanaka asati ashandiswa.

2. Zvinodiwa muUnited States

MuUnited States, iyo Chikafu neDrug Administration (FDA) inopa gwara uye mirau yekuuraya hutachiona hwekufema ventilators.Zvinoenderana neFDA's "Nhungamiro yeIndasitiri uye FDA Vashandi - Kugadzira Zvishandiso zvekurapa muHutano Zvirongwa: Nzira dzekusimbisa uye Kuisa Mazita," mavheti ekufema anofanirwa kuita nzira yakasimbiswa yekudzokorora kuti ive nechokwadi chekuchengetedza kwavo uye kushanda.

Pamusoro pezvo, iyo Association for the Advancement of Medical Instrumentation (AAMI) inoburitsa zviyero zvakaita se "ANSI/AAMI ST79:2017 - Comprehensive Guide to Steam Sterilization uye Sterility Assurance in Health Care Facilities."Iyi chiyero inodonongodza maitiro akanakisa ekuuraya hutachiona uye sterilization yemidziyo yekurapa, kusanganisira yekufema, kudzivirira kutapukira kwakabatana nehutano.

3. Zvinodiwa zveEurope

MuEurope, zvinodikanwa zvekuuraya hutachiona zvekufema ventilator zvinotongwa neEuropean Committee for Standardization (CEN) neEuropean Medicines Agency (EMA).Iyo CEN yakagadzira yakajairwa "EN ISO 17664: 2017 - Sterilization yeMedical Devices - Ruzivo ruchapihwa neMugadziri weKugadziridzwa kweResterilizable Medical Devices" kutungamira vagadziri mukupa mirairo yekuuraya hutachiona hwemidziyo yekurapa.

Zvakare, iyo EMA inopa nhungamiro uye mirairo yekuuraya hutachiona hwemidziyo yekurapa, kusanganisira yekufema maventilator.Iyo "Nhungamiro pamusoro peHunhu, Kuchengetedzeka, uye Kubudirira kweMidziyo Yekurapa" yakapihwa neEMA inosimbisa kukosha kwemaitiro ekuuraya hutachiona kwakakodzera kuti ave nechokwadi chekuchengetedzwa kwevarwere uye kushanda kwechigadzirwa.

Zvinodiwa zvekuuraya hutachiona uye mirau yekufema maventilator zvinosiyana munyika dzakasiyana siyana, zvichiratidza kuzvipira kwepasirese kuchengetedzeka kwemurwere uye kutonga kwehutachiona.MuChina, National Health Commission uye State Administration yeMusika Regulation inopa nhungamiro uye zviyero zvekuuraya hutachiona hwemidziyo yekurapa, kusanganisira yekufema.MuUnited States, iyo Chikafu neDrug Administration uye iyo Association for the Advancement of Medical Instrumentation vanoita basa rakakosha mukumisa nhungamiro nezviyero.MuEurope, European Committee for Standardization uye European Medicines Agency inova nechokwadi chekuchengetedza uye kushanda kwemidziyo yekurapa kuburikidza nemirairo yavo.

Nekutevedzera izvi zvinodiwa uye mirau, vashandi vehutano vanogona kuchengetedza nharaunda yakachengeteka uye isina hutachiona, kuderedza njodzi yehutano hunoenderana nehutachiona, uye kuve nechokwadi chekushanda kwakakwana kwemafemu ekufema.Izvo zvakakosha kuti zvivakwa zvehutano zvigare zvakagadziridzwa neazvino nhungamiro uye zviyero zvekupa tarisiro yakanakisa kuvarwere.

Rangarira, maitiro akakodzera ekuuraya hutachiona haango chengetedza varwere chete asiwo anobatsira mukubudirira kwese kwehutano hwehutano pasi rese.