Miyero iyo mawiricheya emagetsi anofanirwa kutevedzera mukutengeserana kwenyika
Sechishandiso chakakosha chekubatsira kugadzirisa, mawiricheya emagetsi anoita basa rinowedzera kukosha mukutengeserana kwenyika. Kuti ive nechokwadi chekuchengetedza, kushanda uye kutevedzera mawiricheya emagetsi, nyika nematunhu dzakagadzira nhevedzano yezviyero nemirau. Inotevera ndiyo mipimo mikuru iyomawiricheya emagetsiinofanirwa kutevedzera mukutengeserana kwenyika:
1. EU miitiro yekuwana musika
EU Medical Device Regulation (MDR)
Magetsi mawiricheya akaiswa seKirasi I zvekurapa zvekushandisa mumusika weEU. Zvinoenderana neEU Regulation (EU) 2017/745, mawiricheya emagetsi anotumirwa kunze kwenyika kunhengo dzeEU anofanirwa kuita zvinotevera zvinodiwa:
Inopindirana neEU Akatenderwa Mumiriri: Sarudza anowirirana uye ane ruzivo Mumiriri Akatenderwa weEU kuti abatsire vanogadzira nekukurumidza uye nemazvo kugadzirisa matambudziko akasiyana.
Kunyoreswa kwechigadzirwa: Tumira chikumbiro chekunyoresa chigadzirwa kunhengo yenhengo uko mumiriri weEU aripo uye zadzisa tsamba yekunyoresa.
MDR magwaro ehunyanzvi: Gadzirira CE zvinyorwa zvehunyanzvi zvinosangana nezvinodiwa nemirairo yeMDR. Panguva imwecheteyo, magwaro ehunyanzvi anodawo kuchengetwa nemumiriri weEU kune EU official spot checks.
Declaration of Conformity (DOC): Mawiricheya ndeemidziyo yeKirasi I, uye chiziviso chekuenderana chinodiwa zvakare.
Test standards
EN 12183: Inoshanda kune mawiricheya ane mutoro usingadariki 250kg uye mawiricheya emaoko ane magetsi ekubatsira.
TS EN 12184: Inoshanda kune mawiricheya emagetsi ane kumhanya kwakanyanya kusingadarike 15 km / h uye kutakura imwe uye mutoro usingadariki 300 kg.
2. US market access standards
FDA 510 (k) chitupa
Magetsi mawiricheya anoiswa seClass II michina yekurapa muUnited States. Kuti upinde mumusika weUS, unofanirwa kuendesa gwaro re510K kuFDA uye kubvuma kuongororwa kwehunyanzvi hweFDA. Musimboti weFDA's 510K kuratidza kuti iyo yakaziviswa mudziyo wekurapa wakaenzana nemudziyo wakatengeswa zviri pamutemo muUnited States.
Zvimwe zvinodiwa
Chitupa chekunyoresa: Magetsi mawiricheya anotumirwa kuUnited States anofanirawo kupa chitupa chekunyoresa.
Chinyorwa chekugadzira: Ipa yakadzama chigadzirwa bhuku.
Rezinesi rekugadzira: Rezinesi rekugadzira rinoratidza kuti maitiro ekugadzira anoenderana nemirairo.
Marekodhi ekudzora emhando: Ratidza iwo emhando yekudzora marekodhi ekugadzirwa kwechigadzirwa.
Chirevo chekuongorora chigadzirwa: Ipa mushumo wekuongorora chigadzirwa kuratidza mhando yechigadzirwa
3. UK misika yekuwana zviyero
UKCA certification
Mawiricheya emagetsi anotengeswa kunze kwenyika kuUK midziyo yekurapa yeKirasi I zvinoenderana nezvinodiwa neUKMDR2002 yemidziyo yekurapa uye inoda kunyorera chitupa cheUKCA. Mushure meChikumi 30, 2023, Michina yekurapa yeKirasi I inofanirwa kumakwa nemucherechedzo weUKCA isati yatumirwa kuUK.
Zvinodiwa
Taura yakasarudzika UKRP: Vagadziri vanofanirwa kutsanangura yakasarudzika UK Responsible Person (UKRP).
Kunyoreswa kwechigadzirwa: UKRP yapedza kunyoreswa kwechigadzirwa neMHRA.
Mapepa ehunyanzvi: Kune CE magwaro ehunyanzvi kana UKCA magwaro ehunyanzvi anozadzisa zvinodiwa.
4. Mitemo yepasi rose
ISO 13485
ISO 13485 ndiyo chiyero chepasi rose chekurapa mudziyo wemhando yekutarisira masisitimu. Kunyangwe isiri iyo yakananga kudiwa kwekuwana musika, inopa vimbiso yemhando yekugadzira uye kugadzirwa kwemidziyo yekurapa.
Mhedziso
Magetsi mawiricheya anofanirwa kutevedzera zvakaomesesa zviyero uye mirau mukutengeserana kwepasirese kuti ive nechokwadi chekuchengetedza uye kushanda kwezvigadzirwa. Vagadziri vanofanirwa kunzwisisa zvinotarisirwa zvinodikanwa zvemusika unotangwa uye kuona kuti zvigadzirwa zvavo zvinosangana neakakodzera kuyedzwa zviyero uye tekinoroji yakatarwa. Nekutevedzera zviyero izvi, mawiricheya emagetsi anogona kupinda mumusika wepasirese zvakanaka uye nekupa zvemhando yepamusoro zvekubatsira kuvandudza kune vashandisi pasi rese.
Nguva yekutumira: Zvita-16-2024