Ndeapi maitiro chaiwo ekuchengetedza kwekuita kwe4 mavhiri mobility scooters?

Ndeapi maitiro chaiwo ekuchengetedza kwekuita kwe4 mavhiri mobility scooters?

Iyo yekuchengetedza maitiro ekuita zve4 mavhiri mobility scooterszvinosanganisira zvakawanda. Zvinotevera ndezvimwe zvakatemwa zviyero:

1. ISO zviyero
Sangano reInternational Organisation for Standardization (ISO) rakagadzira nhevedzano yemazinga epasi rose anoshanda kune emagetsi scooters, pakati peiyo ISO 7176 yakajairwa seti inovhara zvinodiwa uye nzira dzekuyedza dzemagetsi mawiricheya uye scooters. Aya mazinga anosanganisira:

Static kugadzikana: Inovimbisa kuti mobility scooter inoramba yakagadzikana pamateru akasiyana uye nzvimbo.
Dynamic kugadzikana: Inoedza kugadzikana kweiyo mobility scooter mukufamba, kusanganisira kutendeuka uye kumira kwechimbichimbi.
Braking performance: Inoongorora kushanda kweiyo mobility scooter's braking system pasi pemamiriro akasiyana
Kushandiswa kwesimba: Inoyera kushanda kwesimba uye hupenyu hwebhatiri hwekufamba scooter
Durability: Inoongorora kugona kwekufamba scooter kutsungirira kushandiswa kwenguva refu uye kuratidzwa kune akasiyana mamiriro ezvakatipoteredza.

2. FDA mitemo
MuUnited States, iyo Chikafu neDrug Administration (FDA) inoronga mafambiro scooters semidziyo yekurapa, saka vanofanirwa kutevedzera mirairo yeFDA, inosanganisira:

Premarket chiziviso (510(k)): Vagadziri vanofanirwa kuendesa premarket chiziviso kuFDA kuratidza kuti mamobility scooters avo akaenzana nemidziyo inowanikwa zviri pamutemo pamusika.
Quality System Regulation (QSR): Vagadziri vanofanirwa kumisa uye kuchengetedza mhando yemhando inoenderana nezvinodiwa neFDA, kusanganisira dhizaini dhizaini, maitiro ekugadzira, uye mushure memusika wekutarisa.
Zvinodiwa zvekuisa mazita: Mobility scooters dzinofanirwa kuve nemazita akakodzera, kusanganisira mirairo yekushandiswa, yambiro yekuchengetedza, uye manejimendi ekugadzirisa.

3. EU mitemo
MuEU, ma mobility scooters anofanirwa kuenderana neMedical Devices Regulation (MDR) uye yakakodzera EN zviyero. Zvinonyanya kudiwa zvinosanganisira:
CE yekumaka: mobility scooters anofanirwa kunge aine CE mucherechedzo unoratidza kutevedzera EU chengetedzo, hutano uye zvakatipoteredza zviyero.
Risk management: vagadziri vanofanirwa kuongorora njodzi kuti vaone njodzi dzinogona kuitika uye kutora matanho ekudzikisa njodzi
Clinical evaluation: mobility scooters inofanirwa kuongororwa nekiriniki kuratidza kuchengetedzeka kwavo uye kuita kwavo
Post-market surveillance: vagadziri vanofanirwa kutarisisa mashandiro ekufambisa scooters pamusika uye kurondedzera chero zviitiko zvakashata kana nyaya dzekuchengetedza.

4. Mimwe mitemo yenyika
Nyika dzakasiyana dzinogona kunge dziine dzadzo chaiyo mirau uye mirau yekufamba scooters. Semuyenzaniso:

Australia: Magetsi mobility scooters anofanirwa kuenderana neAustralia Standard AS 3695, iyo inovhara zvinodiwa zvemagetsi mawiricheya uye mobility scooters.
Canada: Hutano Canada inodzora kufamba scooters semidziyo yekurapa uye inoda kuteedzera iyo Medical Devices Regulations (SOR/98-282)
Iyi miyero nemirairo inovimbisa kuti mavhiri mana emagetsi ekufamba scooters anosangana nezvinodiwa zvakanyanya maererano nekuchengetedza, kuvimbika uye mhando, inopa kuchengetedzwa kwevashandisi.