Nzira yekuwana sei ruzivo rwepasirese certification yemagetsi mawiricheya?

Nzira yekuwana sei ruzivo rwepasirese certification yemagetsi mawiricheya?

Kuwana ruzivo rwepasi rese certification yemagetsi mawiricheya kunosanganisira zvinotevera matanho uye zvinodiwa:

1. Nzwisisa mirairo inoshanda uye zviyero
Magetsi mawiricheyavane zvakasiyana certification zvinodiwa munyika dzakasiyana uye matunhu. MuEU, mawiricheya emagetsi anofanirwa kutevedzera zvinodiwa neMedical Device Regulation (MDR) [Regulation (EU) 2017/745] uye Machinery Directive (MD) [2006/42/EC]. Pamusoro pezvo, iyo Electromagnetic Compatibility Directive (EMC Directive) [2014/30/EU] uye iyo Low Voltage Directive (LVD) [2014/35/EU] inoda kutariswa.

2. Conformity ongororo uye certification matanho
Kurongeka kwechigadzirwa uye kuenderana nzira sarudzo: Sarudza kurongeka kwemagetsi wiricheya uye sarudza yakakodzera nzira yekuongorora nzira. Magetsi mawiricheya anowanzo kurongedzerwa seKirasi I michina yekurapa, asi nekuti inosanganisira madhiraivha emagetsi, angangoda kuongororwa nemutumbi unoziviswa.
Clinical evaluation: Vagadziri vanofanirwa kuita ongororo yekiriniki kuratidza kuchengetedzwa uye kushanda kwechishandiso.
Risk manejimendi: Risk manejimendi anoitwa zvinoenderana neISO 14971 kuona uye kuderedza njodzi dzinogona kunge dziripo panguva yehupenyu hwechishandiso.
Kugadzirira kwegwaro rehunyanzvi: Kusanganisira tsananguro yechigadzirwa, kiriniki yekuongorora report, njodzi manejimendi, kugadzira uye magwaro ekudzora mhando, nezvimwe.
Declaration of Conformity (DoC): Mugadziri anofanirwa kusaina uye kuburitsa chiziviso chekuenderana chinotaura kuti wiricheya yemagetsi inoenderana nemirairo nemitemo yeEU.
Yakaziviswa ongororo yemuviri: Sarudza boka rakaziviswa kuti riongorore uye ribvumire magwaro ehunyanzvi echigadzirwa, manejimendi enjodzi, kuongororwa kwekiriniki, nezvimwe.

3. Zvakananga zvinodiwa kuti CE certification
Iyo CE certification yemagetsi mawiricheya muEU inofanirwa kutevedzera EN 12184 yakajairwa, iyo inotsanangura izvo chaizvo zvinodiwa uye nzira dzekuyedza dzemagetsi mawiricheya. Yemukati meyedzo inosanganisira yekuyedza kuchengetedza, simba uye kugadzikana kuyedza, brake system kuyedza, uye kuchengetedza kwemagetsi uye kuyedza kuita

4. Zvinodiwa zveFDA 510K chitupa
MuUnited States, mawiricheya emagetsi, seKirasi II michina yekurapa, inofanirwa kupasa iyo FDA's 510K gwaro rekuongorora. Izvi zvinosanganisira matanho akadai seyakajairwa ongororo yekushandiswa, gwaro riripo uye kudzosa data, kuenzanisa kwemusika uye kunyora zvinyorwa

5. Kuwana tsamba yemvumo
Mushure mekupasa chitupa cheFDA 510K, wiricheya yemagetsi inogashira tsamba yemvumo, rinova gwaro rakakosha rinosimbisa kutevedza kwechigadzirwa.

6. Zvimwe zvitupa
Pamusoro peEC uye FDA 510K chitupa, mawiricheya emagetsi angangodawo kupasa zvimwe zvitupa zvepasi rose, senge CB certification (International Electrotechnical Commission Electrical Product Conformity Testing Certification)

Nekutevera matanho ari pamusoro uye zvinodiwa, vagadziri vanogona kuve nechokwadi chekuti mawiricheya emagetsi anozadzikisa zvinodiwa zvemusika wepasirese, nekudaro zviri pamutemo uye zvakachengeteka kupinda mumusika unotangwa.