Unayo ntoni uMthetho weSixhobo sezoNyango we-EU kwizithuthuthu zokuhamba?

Unayo ntoni uMthetho weSixhobo sezoNyango we-EU kwizithuthuthu zokuhamba?
I-EU inolawulo olungqongqo kakhulu lwezixhobo zonyango, ngakumbi ngokuphunyezwa koMthetho omtsha we-Medical Device Regulation (MDR), imimiselo yokuncedisa ukuhamba njengeisikuta sokuhambas nazo zicace ngakumbi. Oku kulandelayo yimimiselo ephambili yee-scooters zokushukuma phantsi koLawulo lweSixhobo sezoNyango se-EU:

1. Ukuhlelwa kunye nokuThotyelwa
Izihlalo zabakhubazekileyo ezenziwe ngesandla, ii-wheelchairs zombane kunye ne-mobility scooters zonke zihlelwa njengezixhobo zonyango ze-Class I ngokweSihlomelo VIII iMithetho 1 kunye ne-13 ye-EU Medical Device Regulation (MDR). Oku kuthetha ukuba ezi mveliso zithathwa njengeemveliso ezinomngcipheko ophantsi kwaye abavelisi banokubhengeza ukuba iimveliso zabo zithobela iimfuno zolawulo ngokwazo.

2. Uxwebhu lobuGcisa kunye nokuMakisha iCE
Abavelisi kufuneka balungiselele amaxwebhu obugcisa, kubandakanywa uhlalutyo lomngcipheko kunye nokubhengezwa kokuthotyelwa, ukubonisa ukuba iimveliso zabo ziyahlangabezana neemfuno ezibalulekileyo ze-MDR. Nje ukuba zigqityiwe, abavelisi banokufaka isicelo sophawu lwe-CE, bavumele iimveliso zabo ukuba zithengiswe kwimarike ye-EU

3. Imigangatho yaseYurophu
Ii-scooters zokuhamba kufuneka zihambelane nemigangatho ethile yaseYurophu, kubandakanywa kodwa kungaphelelanga apho:

I-TS EN 12182 ichaza iimfuno jikelele kunye neendlela zokuvavanya iimveliso ezincedisayo kunye nezixhobo zobugcisa kubantu abakhubazekileyo.

I-EN 12183: Icacisa iimfuno ngokubanzi kunye neendlela zokuvavanya kwizitulo ezinamavili eziqhutywa ngesandla

I-TS EN 12184 ichaza iimfuno jikelele kunye neendlela zokuvavanya izitulo ezinamavili zombane okanye ibhetri, ii-scooters zokuhamba kunye neetshaja zebhetri.

Uthotho lwe-ISO 7176: Ichaza iindlela ezahlukeneyo zovavanyo lwezitulo ezinamavili kunye nee-scooters zokushukuma, kubandakanya iimfuno kunye neendlela zovavanyo zobungakanani, ubunzima kunye nendawo yokuhambisa esisiseko, isantya esiphezulu, kunye nokukhawulezisa kunye nokuhla.

4. Uvavanyo lokusebenza kunye nokhuseleko
Ii-scooters zokuhamba kufuneka ziphumelele uthotho lweemvavanyo kunye nokhuseleko, kubandakanya iimvavanyo zoomatshini kunye nokuqina, ukhuseleko lombane kunye novavanyo lokuhambelana kwe-electromagnetic (EMC), njl.

5. Ukongamela imarike kunye nokongamela
Ummiselo omtsha we-MDR womeleza ukulawulwa kwemarike kunye nokongamela izixhobo zonyango, kubandakanywa nokunyusa uvandlakanyo olulungelelanisiweyo lophando lwezonyango olunqamleza imida, ukomeleza iimfuno zolawulo lwasemva kwentengiso kubavelisi, kunye nokuphucula iindlela zolungelelwaniso phakathi kwamazwe e-EU.

6. Ukhuseleko lwesigulane kunye nolwazi olungafihliyo
Ummiselo we-MDR ugxininisa ukhuseleko lwesigulane kunye nolwazi olungafihliyo, olufuna inkqubo yokuchongwa kwesixhobo esisodwa (i-UDI) kunye nedatha yedatha ye-EU ebanzi yesixhobo sonyango (EUDAMED) ukuphucula ukulandelwa kwemveliso.

7. Ubungqina bezonyango kunye nokuhlolwa kweemarike
Ulawulo lwe-MDR lukwaqinisa imigaqo yobungqina bekliniki, kubandakanywa inkqubo yogunyaziso yophando lwezonyango olunamaziko amaninzi alungelelaniswe kwi-EU iphela, kwaye yomeleza iimfuno zolawulo lwemarike.

Ngamafutshane, imimiselo yezixhobo zonyango ze-EU kwii-scooters zokushukuma ibandakanya ukuhlelwa kwemveliso, izibhengezo zokuthotyelwa, imigangatho yaseYurophu ekufuneka ilandelwe, uvavanyo lokusebenza nokhuseleko, ukubeka iliso kunye nokongamela kweemarike, ukhuseleko lwesigulane nolwazi olucacileyo, kunye nobungqina bekliniki kunye nokuhlolwa kwemarike. Le mimiselo yenzelwe ukuqinisekisa ukhuseleko kunye nokusebenza kwezixhobo zokuncedisa ukuhamba ezifana ne-mobility scooters kunye nokukhusela impilo kunye namalungelo abathengi.

Loluphi uvavanyo lokusebenza kunye nokhuseleko olufunekayo kwii-scooters zokuhamba?

Njengesixhobo esincedisayo sokuhamba, uvavanyo lokusebenza kunye nokhuseleko lwee-scooters zokuhamba lungundoqo ukuqinisekisa ukhuseleko lomsebenzisi kunye nokuthotyelwa kwemveliso. Ngokweziphumo zophando, ezi zilandelayo zezona ziphambili iimvavanyo kunye nokhuseleko ekufuneka zenziwe ii-scooters zokuhamba:

Esona santya siphezulu sovavanyo lokuqhuba:

Esona santya siphezulu sokuqhuba se-scooter sokushukuma akufanele sidlule kwi-15 km/h. Olu vavanyo luqinisekisa ukuba isithuthuthu sokushukuma sisebenza ngesantya esikhuselekileyo ukunciphisa umngcipheko weengozi.
Uvavanyo lokusebenza kweBraking:
Ibandakanya ukunyanzeliswa kwendlela ethe tye kunye nolona vavanyo lukhuselekileyo lwethambeka lokuqinisekisa ukuba isithuthuthu sinokumisa ngempumelelo phantsi kweemeko zendlela ezahlukeneyo.

Ukusebenza kwe-Hill-hold kunye novavanyo oluzinzileyo lozinzo:
Uvavanya uzinzo lwesithuthuthu kwithambeka ukuqinisekisa ukuba asityibiliki xa sipakwe kwithambeka.

Uvavanyo lozinzo olunamandla:
Ivavanya uzinzo lwe-scooter ngexesha lokuqhuba, ngakumbi xa ujika okanye udibana neendlela ezingalinganiyo

Umqobo kunye novavanyo lokuwela umsele:
Ivavanya ubude kunye nobubanzi bemiqobo enokuthi isithuthuthu siwele ukuvavanya ukudlula kwayo

Uvavanyo lwesakhono sokunyuka kwiBanga:
Ivavanya isakhono sokuqhuba sesikuta kwithambeka elithile

Ubuncinci bovavanyo lweradiyasi:
Uvavanya ukukwazi kwesikuta ukujika kwesona sithuba sincinci, esibaluleke ngakumbi ekusebenzeni kwindawo emxinwa.

Uvavanyo lomgama wokuqhuba ngethiyori:
Ivavanya umgama onokuwuhamba isikuta emva kwentlawulo enye, ebaluleke kakhulu kwizithuthuthu zombane.

Uvavanyo lwenkqubo yamandla kunye nolawulo:
Kubandakanya uvavanyo lolawulo lokutshintsha, uvavanyo lwetshaja, uvavanyo loxinzelelo lokuqhuba ngexesha lokutshaja, amandla kuvavanyo lokulawula umqondiso, uvavanyo lokukhusela isitishi semoto, njl.njl. ukuqinisekisa ukhuseleko kunye nokuthembeka kwenkqubo yombane

Uvavanyo lokhuseleko lwesekethe:
Vavanya ukuba ingaba zonke iingcingo kunye noqhagamshelo lwesithuthuthu sokushukuma zinokukhuselwa ngokufanelekileyo kwi-overcurrent

Uvavanyo lokusetyenziswa kwamandla:
Qinisekisa ukuba ukusetyenziswa kwamandla e-scooter yokushukuma akudluli kwi-15% yezalathi ezichaziweyo zomenzi.

Uvavanyo lwamandla ebrake yokupaka:
Ukuvavanya ukusebenza kunye nokuzinza kwebhuleki yokupaka emva kokusetyenziswa kwexesha elide

Isihlalo (ngasemva) sovavanyo lwe-cushion flame retardancy:
Qinisekisa ukuba isihlalo (ngasemva) umcamelo wesikuta sokushukuma asivelisi umsi oqhubekayo kunye nokuvutha kwedangatye ngexesha lovavanyo.

Uvavanyo lweemfuno zamandla:
Kubandakanya uvavanyo lwamandla angatshintshiyo, uvavanyo lwamandla empembelelo kunye novavanyo lwamandla okudinwa ukuze kuqinisekiswe amandla olwakhiwo kunye nokuqina kwesithuthuthu sokushukuma.

Uvavanyo lwemfuno yemozulu:
Emva kokulinganisa imvula, ubushushu obuphezulu kunye novavanyo lobushushu obuphantsi, qinisekisa ukuba i-mobility scooter inokusebenza ngokuqhelekileyo kwaye ihlangabezane nemigangatho efanelekileyo.

Ezi zinto zovavanyo zibandakanya ukusebenza, ukhuseleko kunye nokuqina kwe-scooter yokuhamba, kwaye ngamanyathelo abalulekileyo okuqinisekisa ukuba i-scooter yokuhamba iyahambelana nemimiselo ye-EU MDR kunye neminye imigangatho efanelekileyo. Ngolu vavanyo, abavelisi banokuqinisekisa ukuba iimveliso zabo zihlangabezana nazo zonke iimfuno eziyimfuneko zokhuseleko kunye nokusebenza ngaphambi kokuba zifakwe emarikeni.