Izindaba

Njengamanje, uveli coronavirus (Covid-19) ubhubhane uyasakazeka. Ukusakazeka komhlaba wonke kuhlola ikhono lawo wonke amazwe ukulwa nobhubhane. Ngemuva kwemiphumela emihle yokuvimbela nokulawulwa kwe-ebhubhane kanye nokulawula eChina, amabhizinisi amaningi asekhaya ahlose ukukhuthaza imikhiqizo yawo ukusiza amanye amazwe nezifunda ngokuhlanyisana nobhubhane. NgoMashi 31, 2020, uMnyango Wezentengiselwano, ukuphathwa kwamasiko okujwayelekile kanye nokuphathwa kwezidakamizwa kweChina kwakhipha isimemezelo esihlanganyelwe kumadivayisi wezokwelapha ahlobene nokuvimbela ama-coronavirus ahlobene (njengemaski yezokwelapha, izigqoko zokuvikela ezokwelapha, umoya wokuvikela kanye I-thermometers ethambile), ebeka ukuthi kusuka ngo-Ephreli 1, abathengisi bamanye imikhiqizo kumele bafakazele ukuthi bathole isitifiketi sokubhaliswa kwamadivayisi wezokwelapha eChina futhi bahlangabezana namazinga ekhwalithi we emazweni noma izifunda. Amasiko angakhipha izimpahla kuphela ngemuva kokuthi ziqinisekiswe njengezifaneleko.

Isimemezelo esihlanganyelwe sikhombisa ukuthi iChina inamathela ngokubaluleka okukhulu kwikhwalithi yezokwelapha esetshenzisiwe. Lokhu okulandelayo kufingqiwe kwezinkinga ezithile okulula ukudideka lapho kuthunyelwa e-European Union nase-United States.

iyuniyani yase-Europe

(1) NgoMark CE

CE ngumphakathi waseYurophu. I-CE Mark iyimodeli yokulawula i-EU yemikhiqizo ebhalwe ku-EU. Emakethe ye-EU, isitifiketi se-EU, isitifiketi se-CE singokwesitifiketi sokulawulwa komthethonqubo. Noma ngabe imikhiqizo ekhiqizwe amabhizinisi ngaphakathi kwe-EU noma imikhiqizo ekhiqizwa kwamanye amazwe ifuna ukujikeleza ngokukhululeka emakethe ye-EU, uphawu lwe-EU kumele lufanelwe ukukhombisa ukuthi imikhiqizo ihambisana nezidingo eziyisisekelo zendlela entsha yokuvumelanisa kwezobuchwepheshe nokuma okujwayelekile. Ngokwezidingo ze-PPE ne-MDD / MDR, imikhiqizo ethunyelwa ku-EU kufanele ibhalwe ngophawu lwe-CE.

(2) Mayelana nezitifiketi

Ukunamathisela uphawu lwe-CE isinyathelo sokugcina ngaphambi kokuthi umkhiqizo ungenise imakethe, okukhombisa ukuthi zonke izinqubo seziqediwe. Ngokwezidingo ze-PPE ne-MDD / MDR, imishini yokuzivikela (efana ne-Class III yokuvikela umuntu) noma imishini yezokwelapha (efana ne-class is merililization) kufanele ihlolwe yi-European Union . Isitifiketi sezokwelapha CE kufanele sikhishwe ngumzimba owazisiwe, futhi isitifiketi kufanele sibe nenombolo yomzimba owazisiwe, okungukuthi, ikhodi enamadijithi amane ayingqayizivele.

(3) Izibonelo zezidingo zemikhiqizo yokuvimbela ubhubhane

1. Imaski ihlukaniswe ngamamaski ezokwelapha kanye namaski avikelekile.

Ngokusho kwe-EN14683, imaski ihlukaniswe izigaba ezimbili: Thayipha ngingu-I II / iir. Thayipha imaskhi ilungele kuphela iziguli kanye nabanye abantu ukunciphisa ingozi yokutheleleka nokudlulisela, ikakhulukazi esimweni sezifo ezithathelwanayo noma izifo eziwumshayabhuqe. Uhlobo lwe-II Mask lusetshenziswa ikakhulukazi udokotela egumbini lokusebenza noma elinye imvelo yezokwelapha enezidingo ezifanayo.

2 Izinga laseYurophu lezingubo zokuzivikela zezokwelapha lise-EN14126.

(4) Izindaba zakamuva

I-EU 2017/745 (MDR) iyindlela entsha ye-EU yezokwelapha ye-EU. Njengohlobo oluthuthukisiwe lwe-93/42 / EEC (MDD), umthethonqubo uzoqala ukusebenza futhi wenziwe ngokugcwele ngoMeyi 26, 2020. NgoMashi 25, i-European Commission yamemezela isiphakamiso sokuhlehlisa ukuqaliswa kwe-MDR ngonyaka owodwa, Okuthunyelwe ekuqaleni kuka-Ephreli ukuthola ukuvunywa yiPhalamende laseYurophu noMkhandlu ngaphambi kokuphela kukaMeyi. Bobabili i-MDD ne-MDR bacacisa ukusebenza komkhiqizo ukuze kuqinisekiswe impilo kanye nokuphepha kwabasebenzisi.