Chii chinonzi EU Medical Device Regulation chine chekufamba scooters?

Chii chinonzi EU Medical Device Regulation chine chekufamba scooters?
IEU ine mutemo wakasimba kwazvo wezvishandiso zvekurapa, kunyanya nekushandiswa kweiyo itsva Medical Device Regulation (MDR), iyo mirairo pamusoro pezvibatsiro zvekufambisa senge.mobility scooters zvakare akajeka. Iyi inotevera mirairo mikuru yekufamba scooters pasi peEU Medical Device Regulation:

1. Kuronga uye Kutevedzera
Manual wiricheya, mawiricheya emagetsi nemamobility scooters ese akaiswa mukirasi yemidziyo yekurapa maererano neAnnex VIII Mitemo 1 uye 13 yeEU Medical Device Regulation (MDR). Izvi zvinoreva kuti zvigadzirwa zvinoonekwa sezvigadzirwa zvine njodzi yakaderera uye vagadziri vanogona kuzivisa kuti zvigadzirwa zvavo zvinoenderana nezvinodiwa nemutemo ivo pachavo.

2. Technical Documentation uye CE Kumaka
Vagadziri vanofanirwa kugadzirira zvinyorwa zvehunyanzvi, kusanganisira kuongororwa kwenjodzi uye kuzivisa kwekuenderana, kuratidza kuti zvigadzirwa zvavo zvinosangana nezvinodiwa zveMDR. Kana yapera, vagadziri vanogona kunyorera CE mucherechedzo, vachibvumira zvigadzirwa zvavo kuti zvitengeswe pamusika weEU

3. Mitemo yeEurope
Mobility scooters inofanirwa kuenderana neyakajeka miyero yeEurope, kusanganisira asi isina kugumira kune:

TS EN 12182: Inotsanangura zvakajairwa uye nzira dzekuyedza dzezvigadzirwa zvekubatsira uye tekinoroji zvekubatsira vanhu vakaremara.

TS EN 12183: Inotsanangura zvakajairwa zvinodikanwa uye nzira dzekuyedza dzemawiricheya emaoko

TS EN 12184: Inotsanangura zvinodikanwa zvakajairwa uye nzira dzekuyedza dzemagetsi kana bhatiri mawiricheya, mobility scooters, uye majaja ebhatiri.

TS ISO 7176 nhepfenyuro: Inotsanangura nzira dzakasiyana dzekuedza dzemawiricheya uye mobility scooters, kusanganisira zvinodiwa uye nzira dzekuyedza dzezviyero, misa uye yakakosha nzvimbo yekufambisa, kumhanya kwakanyanya, uye kukurumidza uye kudzika.

4. Kuita uye kuchengetedzwa kwekuongorora
Mobility scooters dzinofanirwa kupasa dzakatevedzana dzekuita uye kuchengetedza bvunzo, kusanganisira yemakanika uye durability bvunzo, kuchengetedzeka kwemagetsi uye electromagnetic kuenderana (EMC) bvunzo, nezvimwe.

5. Kutariswa kwemusika uye kutarisa
Iyo mitsva yeMDR regulation inosimbisa kutariswa kwemusika uye kutariswa kwemidziyo yekurapa, kusanganisira kuwedzera kuongororwa kwakarongwa kwekuyambuka-muganho kuferefetwa kwekiriniki, kusimbisa mushure memusika zvinotarisirwa kune vanogadzira, nekuvandudza nzira dzekudyidzana pakati penyika dzeEU.

6. Kuchengeteka kwemurwere uye kubuda pachena kweruzivo
Mutemo weMDR unosimbisa kuchengetedzeka kwemurwere uye kubuda pachena kweruzivo, zvinoda yakasarudzika chiziviso chemudziyo (UDI) system uye yakazara EU yezvokurapa mudziyo dhatabhesi (EUDAMED) yekuvandudza chigadzirwa traceability.

7. Uchapupu hwekiriniki uye kutarisa kwemusika
Iyo MDR regulation inosimbisawo mitemo yehumbowo hwekiriniki, kusanganisira yakawanda-center yekiriniki yemvumo yekuferefeta nzira inorongedzerwa muEU yese, uye inosimbisa misika yekutarisa zvinodiwa.

Muchidimbu, iyo EU yezvokurapa mudziyo mirau pakufamba scooters inosanganisira kupatsanurwa kwechigadzirwa, zviziviso zvekuteerera, zviyero zveEuropean zvinofanirwa kuteverwa, kuita uye kuchengetedzwa kwekuyedza, kutarisa kwemusika uye kutarisa, kuchengetedza kwevarwere uye kubuda pachena kweruzivo, uye humbowo hwekiriniki uye kutariswa kwemusika. Iyi mirairo inoitirwa kuve nechokwadi chekuchengetedza uye kushanda kwekufamba kwekubatsira zvishandiso senge mobility scooters uye kuchengetedza hutano uye kodzero dzevatengi.

Ndeapi maitiro uye bvunzo dzekuchengetedza anodiwa kune mobility scooters?

Sechishandiso chekubatsira chekufambisa, kuita uye kuyedza kuchengetedzwa kwema mobility scooters kwakakosha kuti uve nechokwadi chekuchengetedzwa kwemushandisi uye kutevedza kwechigadzirwa. Zvinoenderana nemhedzisiro yekutsvaga, anotevera ndiwo makuru ekuita uye bvunzo dzekuchengetedza dzinofanirwa kuitwa nema mobility scooters:

Maximum kutyaira kumhanya bvunzo:

Iyo yakanyanya kumhanya yekutyaira yekufamba scooter haifanirwe kudarika 15 km / h. Muedzo uyu unova nechokwadi chekuti mobility scooter iri kushanda nekumhanya kwakachengeteka kuderedza njodzi yetsaona.
Braking performance test:
Inosanganisira yakachinjika mabhureki emugwagwa uye yakachengeteka yakatenuka mabhureki bvunzo kuti ive nechokwadi chekuti scooter inogona kunyatsomira pasi pemamiriro akasiyana emugwagwa.

Hill-inobata kuita uye static kugadzikana bvunzo:
Inoedza kugadzikana kwescooter pamateru kuti ive nechokwadi chekuti haitsvedzeri kana yamiswa pamateru.

Dynamic kugadzikana bvunzo:
Inoongorora kugadzikana kwe scooter panguva yekutyaira, kunyanya kana uchitendeuka kana kusangana nemigwagwa isina kuenzana

Chipingamupinyi uye gomba rekuyambuka bvunzo:
Inoedza hurefu nehupamhi hwezvipingamupinyi izvo scooter inogona kuyambuka kuti iongorore kupfuura kwayo

Giredhi rekukwira kugona bvunzo:
Inoongorora kugona kwekutyaira kwescooter pane imwe nzvimbo yakatsetseka

Minimum turning radius bvunzo:
Inoedza kugona kwe scooter kutendeuka munzvimbo diki, iyo inonyanya kukosha pakushanda munzvimbo yakamanikana.

Theoretical driving distance test:
Inoongorora chinhambwe chinogona kufamba nescooter mushure mekuchaja kamwe chete, iyo inonyanya kukosha kune emagetsi scooters.

Simba uye control system bvunzo:
Inosanganisira control switch bvunzo, charger bvunzo, kutyaira kudzvinyirira bvunzo panguva yekuchaja, simba paKudzora chiratidzo bvunzo, mota yekudzivirira bvunzo yekudzivirira, nezvimwe kuve nechokwadi chekuchengetedza uye kuvimbika kwemagetsi system

Muedzo wekudzivirira wedunhu:
Edza kana waya dzese uye zvinongedzo zvemobility scooter zvinogona kuchengetedzwa nemazvo kubva kune overcurrent

Muedzo wekushandisa simba:
Ita shuwa kuti mashandisirwo emagetsi e mobility scooter haapfuure 15% yezviratidzi zvakatsanangurwa nemugadziri.

Parking brake kuneta simba bvunzo:
Edza kushanda uye kugadzikana kwebhureki yekupaka mushure mekushandisa kwenguva refu

Chigaro (kumashure) cushion flame retardancy test:
Ita shuwa kuti chigaro (kumashure) cushion ye mobility scooter haiburitse kupfungaira kunofambira mberi uye kupisa kwemurazvo panguva yekuedzwa.

Simba rinodiwa bvunzo:
Inosanganisira static simba bvunzo, kukanganisa simba bvunzo uye kuneta simba kuyedza kuve nechokwadi chechimiro chesimba uye kusimba kweiyo mobility scooter.

Kuedzwa kwemamiriro ekunze:
Mushure mekuenzanisa mvura, tembiricha yakakwira uye yakaderera tembiricha bvunzo, ita shuwa kuti mobility scooter inogona kushanda zvakajairwa uye kusangana nematanho akakodzera.

Izvi zvinhu zvekuyedza zvinofukidza kuita, kuchengetedzeka uye kusimba kweiyo mobility scooter, uye matanho akakosha ekuona kuti mobility scooter inoenderana neEU MDR mirau uye mamwe akakodzera mwero. Kuburikidza nemiedzo iyi, vagadziri vanogona kuona kuti zvigadzirwa zvavo zvinozadzisa zvese zvinodiwa kuchengetedza uye kuita zvinodiwa zvisati zvaiswa pamusika.