UKCA certification inoreva zviyero zvetifiketi zvinoda kuzadzikiswa pakutengesa michina yekurapa mumusika weUK. Zvinoenderana nemirairo yeBritish, kutanga kubva muna Ndira 1, 2023, zvishandiso zvekurapa zvinotengeswa kuUK zvinofanirwa kuenderana neUKCA certification zvinodiwa, kutsiva yekare CE certification. Kuwana UKCA certification kunoda kuteedzera mirau uye zviyero zvehurumende yeBritish uye masangano akakodzera, uye mashandisirwo anoenderana uye maitiro ekuongorora.
Chii chinonzi UK Conformity Assessment (UKCA) chitupa?
UKCA certification inzira yekutevedzera yemidziyo yekurapa kuti uwane mukana wemusika muUnited Kingdom (UK). MuUK, kuiswa kweUKCA mamaki kwakatsiva yekare CE mamaki. Ichi chitupa chakakosha kuti uve nechokwadi chekuti mudziyo wako wekurapa unoenderana nezvinodiwa neUK Medical Device Regulation (UK MDR).
Ndeapi michina yekurapa inoda UKCA certification?
Mumusimboti, zvese zvishandiso zvekurapa zvine mazinga epamusoro emhando kuti atengeswe mumusika weUK anoda kuwana UKCA certification. Izvi zvinosanganisira zvichangobva kutangwa uye zvigadzirwa zvakatobvumidzwa.
Zvishandiso zvekurapa zvinoda UKCA certification zvinosanganisira asi hazvina kuganhurirwa kune: compression therapy midziyo, defibrillators, infusion pombi, pacemakers, yekurapa laser midziyo, X-ray michina, etc. Zvisinei, zvakananga zvinodiwa zvinogona kusiyana zvichienderana nezvinhu zvakaita sechikamu uye chinangwa. yemudziyo. Zvinokurudzirwa kuti ubvunze sangano rezvitupa rehunyanzvi kana dhipatimendi rakakodzera kuti uwane ruzivo rwakanyanya.
Ndiani wandinofanira kutsvaga UKCA certification?
Kuti uwane chitupa cheUKCA chezvishandiso zvekurapa, vagadziri vanofanirwa kupa sangano rechitatu rinonzi UK Approved Body kuti riite ongororo yekuteerera uye chitupa chinosangana neUKCA zvinodiwa.
Ndeapi matanho anodiwa kune UKCA certification?
Iyo UKCA certification process inosanganisira kupatsanurwa kwechigadzirwa, tekinoroji gwaro rekuongorora, yemhando yekuongorora uye yekupedzisira chitupa. Zvese zvinodiwa zvinodiwa zvinofanirwa kusangana kuratidza kutevedzera.
Sarudza chigadzirwa chiyero: Sarudza kana chigadzirwa chako chichida UKCA certification uye inodiwa chiyero chechitupa.
Kugadzirira kwezvinyorwa uye kuyedzwa: Gadzirira chigadzirwa magwaro ehunyanzvi uye ita bvunzo dzinodiwa uye kuongororwa kwechigadzirwa kuti uve nechokwadi chekutevedzera zvinoenderana neEU tekinoroji zviyero.
Ipa sangano retifiketi: Sarudza UK-yakatenderwa certification body uye uvape kuti vaongorore uye vasimbise zvigadzirwa zvako.
Ita ongororo: Boka rezvitupa richaita ongororo yechigadzirwa, kusanganisira ongororo yezvinyorwa uye zvinokwanisika pa-saiti kuongororwa.
Kuburitswa kwechitupa: Kana chigadzirwa chichisangana nezvinodiwa, sangano retifiketi rinoburitsa UKCA certification.
Ndeapi mapoinzi enguva aunoda kutarisisa kune UKCA certification?
Hurumende yeBritain yakaita hurongwa hwekuchinja kweUKCA certification. Pamidziyo yekurapa, nguva iyi yakawedzerwa zvakare muna Chikunguru 2023. Nguva yekushanda inoenderana nechikamu chemidziyo yekurapa uye rudzi rwechitupa cheEU.
Izvi zvinoreva kuti vagadziri vemidziyo yekurapa vanogona kuisa zvigadzirwa zvavo pamusika weUK vachishandisa zvese UKCA uye CE mamaki zuva risati rataurwa. Zvinokurudzirwa kunyorera UKCA certification nekukurumidza sezvinobvira kuti uve nechokwadi chekuwana musika panguva uye kudzivirira kunonoka.
Nguva yekutumira: Zvita-28-2023