Menene Dokokin Na'urar Likitan EU ke da shi don babur motsi?
EU tana da tsauraran ƙa'idoji na na'urorin likitanci, musamman tare da aiwatar da sabuwar Dokar Na'urar Kiwon Lafiya (MDR), ƙa'idodi kan taimakon motsi kamar su.babur motsis kuma sun fi bayyana. Waɗannan su ne manyan ƙa'idodi don babur motsi a ƙarƙashin Dokar Na'urar Likita ta EU:
1. Rarrabewa da Biyayya
Kujerun guragu na hannu, kujerun guragu na lantarki da na'urorin motsa jiki duk an rarraba su azaman na'urorin likitanci na Class I bisa ga Annex VIII Dokokin 1 da 13 na EU Medical Device Regulation (MDR). Wannan yana nufin cewa waɗannan samfuran ana ɗaukar samfuran ƙananan haɗari kuma masana'antun za su iya ayyana cewa samfuran su sun cika ka'idodin ka'idoji da kansu.
2. Takardun Fasaha da Alamar CE
Masu sana'a dole ne su shirya takaddun fasaha, gami da nazarin haɗari da bayyana daidaito, don tabbatar da cewa samfuran su sun cika mahimman buƙatun MDR. Da zarar an gama, masana'antun za su iya neman alamar CE, suna barin samfuran su sayar da su a kasuwar EU
3. Matsayin Turai
Masu motsi masu motsi dole ne su bi takamaiman ƙa'idodin Turai, gami da amma ba'a iyakance ga:
TS EN 12182: Abubuwan buƙatu na gaba ɗaya da hanyoyin gwaji don samfuran taimako da kayan aikin fasaha ga mutanen da ke da nakasa
TS EN 12183: Kayyade buƙatu na gaba ɗaya da hanyoyin gwaji don kujerun guragu na hannu
TS EN 12184: Kayyade buƙatu na gabaɗaya da hanyoyin gwaji don kujerun guragu na lantarki ko baturi, injin motsa jiki, da caja baturi
TS EN ISO 7176 Jerin: Yana ba da bayanin hanyoyin gwaji daban-daban don kujerun guragu da masu motsi, gami da buƙatu da hanyoyin gwaji don girma, taro da sararin motsa jiki, matsakaicin saurin gudu da haɓakawa da haɓakawa.
4. Gwajin aiki da aminci
Masu motsi masu motsi dole ne su wuce jerin ayyuka da gwaje-gwajen aminci, gami da gwaje-gwajen inji da ɗorewa, amincin lantarki da gwajin dacewa na lantarki (EMC), da sauransu.
5. Kula da kasuwa da sa ido
Sabuwar tsarin MDR yana ƙarfafa kulawar kasuwa da sa ido kan na'urorin likitanci, gami da haɓaka haɓakar kimantawa na binciken asibiti na kan iyaka, ƙarfafa ka'idodin ka'idojin bayan kasuwa ga masana'antun, da haɓaka hanyoyin daidaitawa tsakanin ƙasashen EU.
6. Amintattun marasa lafiya da bayyana gaskiya
Tsarin MDR yana jaddada amincin haƙuri da bayyana gaskiyar bayanai, yana buƙatar tsarin gano na'ura na musamman (UDI) da cikakkiyar bayanan na'urar likitancin EU (EUDAMED) don haɓaka gano samfur.
7. Shaidar asibiti da kula da kasuwa
Ka'idar MDR kuma tana ƙarfafa ka'idodin shaidar asibiti, gami da tsarin ba da izinin bincike na asibiti da yawa wanda aka daidaita a cikin EU, kuma yana ƙarfafa buƙatun kula da kasuwa.
A taƙaice, ƙa'idodin na'urorin likitanci na EU game da babur motsi sun haɗa da rarrabuwar samfur, sanarwar yarda, ƙa'idodin Turai waɗanda dole ne a bi su, aiki da gwajin aminci, kulawa da kasuwa da sa ido, amincin haƙuri da bayyana gaskiya, da shaidar asibiti da kulawar kasuwa. Waɗannan ƙa'idodin an yi niyya ne don tabbatar da aminci da ingancin na'urori masu taimako na motsi kamar su babur motsi da kare lafiya da haƙƙin masu amfani.
Waɗanne ayyuka da gwaje-gwajen aminci ake buƙata don babur motsi?
A matsayin na'urar motsa jiki na taimako, aiki da gwajin aminci na masu motsi shine mabuɗin don tabbatar da amincin mai amfani da yarda da samfur. Dangane da sakamakon binciken, waɗannan su ne manyan ayyuka da gwaje-gwajen aminci waɗanda masu motsi na motsi ke buƙatar sha:
Matsakaicin gwajin saurin tuƙi:
Matsakaicin saurin tuki na babur motsi kada ya wuce 15 km/h. Wannan gwajin yana tabbatar da cewa babur motsi yana aiki a cikin amintaccen sauri don rage haɗarin haɗari.
Gwajin aikin birki:
Ya haɗa da birki a kwance da mafi girman gwajin birki mai tsauri don tabbatar da cewa babur na iya tsayawa da kyau a ƙarƙashin yanayin hanya daban-daban.
Ayyukan riƙon tudu da gwajin kwanciyar hankali:
Yana gwada kwanciyar hankali na babur a kan gangara don tabbatar da cewa baya zamewa lokacin da aka faka akan gangara.
Gwajin kwanciyar hankali mai ƙarfi:
Yana kimanta kwanciyar hankali na babur yayin tuƙi, musamman lokacin juyawa ko cin karo da hanyoyin da ba su dace ba
Gwajin tsallaka shinge da shinge:
Yana gwada tsayi da faɗin shingen da babur zai iya hayewa don kimanta iyawarsa
Gwajin iya hawan daraja:
Yana kimanta ƙarfin tuƙi na babur akan wani gangare
Mafi ƙarancin gwajin radius:
Yana gwada ikon babur don juyawa cikin ƙaramin sarari, wanda ke da mahimmanci musamman don aiki a cikin kunkuntar muhalli
Gwajin nisa na ka'idar tuƙi:
Yana ƙididdige nisan da babur zai iya tafiya bayan caji ɗaya, wanda ke da mahimmanci musamman ga mashinan lantarki
Gwajin tsarin iko da sarrafawa:
Ya haɗa da gwajin sauyawa na sarrafawa, gwajin caja, gwajin danne tuƙi yayin caji, ikon gwajin siginar sarrafawa, gwajin kariyar rumbun mota, da sauransu don tabbatar da aminci da amincin tsarin lantarki.
Gwajin kariyar kewaye:
Gwada ko duk wayoyi da haɗin haɗin keken motsi za a iya kiyaye su da kyau daga wuce gona da iri
Gwajin amfani da wutar lantarki:
Tabbatar cewa yawan wutar lantarki na babur motsi bai wuce 15% na ƙayyadaddun alamomin masana'anta ba.
Gwajin ƙarfin ƙarfin birki na yin kiliya:
Gwada inganci da kwanciyar hankali na birki na filin ajiye motoci bayan amfani na dogon lokaci
Wurin zama (baya) gwajin jinkirin harshen wuta:
Tabbatar cewa kujera (baya) matashin babur motsi baya haifar da ci gaba da hayaki da harshen wuta yayin gwajin.
Gwajin buƙatar ƙarfi:
Ya haɗa da gwajin ƙarfin tsaye, gwajin ƙarfin tasiri da gwajin ƙarfin gajiya don tabbatar da ƙarfin tsari da dorewa na babur motsi.
Gwajin buƙatun yanayi:
Bayan kwaikwayon ruwan sama, babban zafin jiki da gwajin ƙarancin zafin jiki, tabbatar da cewa babur motsi zai iya aiki akai-akai kuma ya dace da ƙa'idodi masu dacewa.
Waɗannan abubuwan gwajin sun ƙunshi aiki, aminci da dorewa na babur motsi, kuma matakai ne masu mahimmanci don tabbatar da cewa babur motsi ya bi ka'idodin EU MDR da sauran ƙa'idodi masu dacewa. Ta hanyar waɗannan gwaje-gwajen, masana'antun za su iya tabbatar da cewa samfuran su sun cika duk mahimman aminci da buƙatun aiki kafin a saka su a kasuwa.
Lokacin aikawa: Janairu-03-2025