CE Disposable Laparoscopic Trocar: Izinqakotho Zokuzimisela

Ukuziqonda Ukumakhiwe kuka-CE kwezitrokaru zokusebenza ngokushesha zokugcina isikhumba

Kungani Ukumakhiwe kuka-CE Kuyimfanele Ukufuna Ukuhlanganisa Emazweni E-EU

Isilumkiso se-CE (Conformité Européenne) asiyi nje isitikha esihle kodwa ngoko ke isilumkiso esisifanayo sokuthi kufanele kwenziwe ngokuzenzakalelayo yezinkampani zokusebenza kwezinhlangano zase-Europe. Uma sibhala ngokuphelele ngamaphoyinti ase-laparoscopic atholakalwa ngokushesha, ukuthi kune-silumkiso se-CE kubonisa ukuthi kuyasebenza ngokuphathelene nokulinganisa okuphambili okwenzekile ngu-EU Medical Device Regulation 2017/745. Abahleli abayishaya lemyalo bafana nezinkinga ezingcono ngoba bazokwazi ukuthengisa noma ukuthengiselwa kwezinto zabo kuzo zonke izindawo zase-EEA ngaphandle kokulandela ukulandela okuphambili. Lokhu silumkiso kusenza ukuthi? Kukhombisa konke okubhekene nalo ukuthi lezizikhumba ziyasebenza ngokuphathelene nokulinganisa okuphambili ngokuhlanganisa ubudlelwano bezempilo, ukusebenza kwazo ngokuphambili kumaqondo, nokuchaza ubukhulu bephrojekthi. Abakompani abayishaya lemyalo bafana nokuthi izinto zabo ziphulwe emagazini, bafana nezimfundo eziningi ezinokuphika kude kwezinkampani zemisiyeni ezingu-500,000, futhi bafana nezinkinga zokugcina ubuso bakho obungabikho ngamashumi amabili.

Ukuchaza kwezinto ezizokuphulwa ngokugcina kwezinto zokusebenza kwezibhanki zase-EU (Iklasi IIa)

Ngaphansi kwezibhanki zase-EU, izinto zokusebenza kwezibhanki zasezibhankeni zokuphulwa ngokugcina zichazwa njenge- Izinto zokusebenza zase-EU Iklasi IIa —isibonelo esihlanganisa izinto ezingasemthwakweni ophakeme okuncane, okufanele:

• Zifikelela emaphakathini amaningi (isibonelo, ukufikelela kumkhono wokubhankisa umsila wokubhankisa),
• Zisusela izinhlobo zokusebenza zomzimba ngapansi kwamashumi amabili namahlanu, noma
• Zinokuthintela isibindi esikhulu uma zingafani.

Le yiklasi iyathinta ukuthi kubaluleke ukuthi i-Notified Body yase-EU ibe yindlela eyodwa yokubonisa ukuthi izinto ziyavuma. Abahleli kufanele bakhombise ukuthi zivuma ngokusebenzisa izindaba zokusebenza zokuhlela, ukuphatha isibindi ngokwesiqephu se-ISO 14971, nokubonisa ukuthi zivuma ngokwesibindi sokusebenza futhi ngokwesibindi sokusebenza.

Ukuvuma kwezindaba zokusebenza zase-EU zokusebenza kwezibhanki zasezibhankeni zokuphulwa ngokugcina (CE)

Izindaba Zokusebenza: Ukuphatha Isibindi, Ukubonisa Isibindi Sokusebenza, Futhi Ukuphatha Ukusebenza Kwabantu

Umbhalo wokusebenzisa izinto zokuziphatha ngokwemithombo kuyisibonelo sokugcina ukuthi kufanele kubhekwe ngokuphelele kwe-MDR yezinto ezizokusebenziswa kanye nezokugcina kwe-CE zezinto zokuziphatha ngokwemithombo zokuziphatha ngokwemithombo. Kufanele kubhekwe ngokuphelele ukuthi kuyini okukhethwe ngokwesifundo, izindlela zokwenza izinto, nokuthi kutholakala ubukhulu bokuphepha nokusebenza kahle. Izinqubo eziphambili zivame ukuba ziyi:

• Ukuphatha izinkinga ngokuphelele ngokuhambisana ne-ISO 14971—kubhekwa kwezinto zokusebenza kwezinto zokuziphatha ngokwemithombo, ukubuyela kwamaphoyinti amabili ngokuphelele, nokuthi kuyini okukhethwe ngokwesifundo ngokwesikhundla sokubeka isihlalo;
• Amaphayile wokubonisa ukuthi izinto zokuziphatha ngokwemithombo ziyisibonelo sokuphepha ngokuphelele kwezinto zokuziphatha ngokwemithombo zokubona ngokuphelele, ngokusebenzisa izindaba zokufunda kwezinsiza zokufunda noma izindaba zokufunda zokwesibonelo sokubona ngokuphelele;
• Ukubonisa ukuthi izinto zokuziphatha ngokwemithombo ziyasebenza ngokuphelele ngokuhambisana ne-IEC 62366-1, kubhekwa kwezindlela zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izinkulungwane zokusebenzisa izinto zokuziphatha ngokwemithombo ngokuphelele ngokusebenzisa izink......

Ukubonisa ukuthi izinto zokuziphatha ngokwemithombo azikwazi ukusebenza ngokuphelele kuyisibonelo sokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwezinkinga zokugcina ukuthi kufanele kubhekwe ngokuphelele kwe......

Umgangatho wokubonisa ukuthi izinto zokuziphatha ngokwemithombo ziyasebenza ngokuphelele nge-Notified Body

Ngokubhaqwa njengamadivayisi we-Clas IIa, amatrokaru we-laparoscopic atholakala kuzo ngokuphathelene ne-CE kufuneka ahlale kwezifundo zokulinganisa ngokuphelele yomthwalo wase-EU. Le ndlela iyaphawula izifundo zezinto ezilandelayo:

1. Isistimu sesiqinisekiso sesifo (QMS) somphathi, esiqinisekiswe ngokusebenza kwi-ISO 13485:2016;
2. Ukuhlukaniswa kwezifundo zezinto zokusebenza—kufaka ukuthi isifundo sokuhlanzwa, ukuthi isifundo sokugcina isikhathi sokusebenza, nokuthi isifundo sokuhlola ubukhulu bokusebenza;
3. Ukuvumela kwezifundo zokusebenza emva kokuthengiswa (PMS) nokuthi kubhekwe ngokujabulisayo.

Ngokuphumelela kwesifundo, umthwalo wase-EU uyaliza i-Certificate yomthwalo wase-EU yokuqinisekisa ngokusebenza ngokulandelayo IX we-MDR 2017/745. Ukuvumela okuphambili kufuna ukuthi kwenziwe izifundo zemithwalo engazihlalwa ngokungafani ngezinyangana zombili—lokhu kuyisibonelo esibalulekile, ngoba 63% yezifundo zokuvumela kwezinhlayiya zokusebenza zasezinsizini zazilinkiwe nezinkinga zokuvumela emva kokuthengiswa (MedTech Europe, 2024).

Ukuthatha isimo, Ubukhulu, nokuthi kubhekwe ngokujabulisayo kwezinhlayiya zokusebenza zokuthengiswa kwe-CE zama-trokaru we-laparoscopic

Izinhlayiya zokubaluleka kwezinhlayiya zokubaluleka: Ukuthintwa kwe-blade, Ukusetyenziswa kwe-shield, nokubhekwa ngokwezinye izinyathelo

Izitrokaru zesikhathi esingasizi sezibhodi zase-Europe (CE) ziyatholakala ngezindlela eziningi zokuhlinzekileyo zokuhlinzekileyo zokugcina zisikwele kusukela ukuthi zihlinze izimpilo yezincwadi. Uma lezi zixhuma kwindawo yomphakathi, isistimu sokubuyisa isikhumba sasemva siphumela ngokushesha, sobuyisa amaphakathi amabi ngokushesha ukuze asizange sibhale ngokungafanelekile. Emva kokusebenzisa isithu, ishildi esisikwele sibuyisa ngokuzenzakalelayo lezi zikhumba ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuyise ngokuzenzakalelayo ukuthi sibuye sibuy......

Ukugxilwa kwe-ISO 13485 nokuziphatha ngokwabantu ngokuphathelene ne-EN ISO 14971 & IEC 62366-1

Ukufumana ukuthi kwenziwe i-ISO 13485:2016 kusho ukuthi unesistimu yokuphatha ubukhulu esebenzayo yokuphatha ubukhulu okubalulekileyo ekwenzeni kwezinto zokusebenza ezihlukene zokugcina izikhathi zokugcina (CE marked disposable laparoscopic trocars) ngokuphathelene nokuhlela, futhi ngokuphathelene nokulawula. Lokho okwenza le ndlela yokusebenza kahle kuyi-EN ISO 14971 yezindaba zokuphatha izinkinga. Ngokuhlanganisa laba amabili, kusiza izindustria ukuthola izinkinga ezingakwazi ukuzalwa ngaphambi kokuba zibe yizinkinga, ukuvavanya ukuthi zingakhi kakhulu, bese kuzinconywa ngaphambi kokuba kubonakale umuntu. Izinkinga zokubhukuda ziyisinye sezinkinga ezikwenzekayo lapha, njengoba kunezinkinga ezingakwazi ukuzalwa ngokwenza izinto ngokungafanele ngezinkampani zokusebenza kwemithombo yezempilo. Kuyisinye sokuthi kubhekwa ukuthi abadokotela bakhuluma ngokuphelele ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okusho ukuthi abadokotela bakhuluma ngokuphatha izinkinga zokusebenza ngokuphatha i-IEC 62366-1, okush......

Ukuhlanganisa kwezinsizakwane kwinzuzo yezinsizakwane kwaye Ukuphatha Kuphela Kwimithambo Yokuqinisekisa

Ukubheka kwezinsizakwane (PMS), Ukuthumela Imibiko Yezinsizakwane, Nokuthabathwa Kwemithambo Yomthombo 83

Umunye wokuphatha ukuthi izinhlelo zokuziphatha kwezomnotho azikwazi ukuphela uma izimkhiwo ze-CE zihlanganiswe. Izimpahla zidinga ukubheka ngaphandle kwezinto ezithile emva kokuthi izimpahla zifika emakethe njengoba kufanele. Ukubheka ngaphandle kwemakethe akuyiyo nje indlela yokugcina amasheku, kodwa yindlela yokubheka ukuthi izimpahla zezinkampani zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zezimpahla zezincwadi zez......

IMIBUZOMA - Amatrocars eziyisisekelo zesikhathi esinye sokulapa ezinamandla emhlabathi ye-EU

Umkhakha we-EU wuYini futhi kuyini okubalulekile ngakho kumatrocars esikhathi esinye sokulapa?

Umkhakha we-EU uyinkhakha eyidingekile ekhombisa ukuthi isikhathi sesiphumo sesikhathi esinye sokulapa, njengokuthi amatrocars esikhathi esinye sokulapa, ayizindikimela izimpendulo zase-EU, ekhombisa ukuthi kunezinhlobo zokuphepha, ukusebenza nokuhlelwa.

Amatrocars esikhathi esinye sokulapa ayalahleka kuziphi izigaba zase-EU MDR?

Amatrocars esikhathi esinye sokulapa ayilahlekile njengezikhathi sesiphumo sezigaba se-IIa ngase-EU MDR, esihlanganisa izikhathi zesiphumo sezinhlobo ezinamandla emhlabathi.

Izinhlobo zokuphepha ziyisisekelo zini kumatrocars esikhathi esinye sokulapa eziyisisekelo zesikhathi esinye sokulapa?

Amatrocars esikhathi esinye sokulapa eziyisisekelo zesikhathi esinye sokulapa ayinamandla okukhupha umshayeli, amashidi ezingqondweni, nezibalo zokubonisa ngokwesibonelo ukukhupha izimpilo zomhlangozi.

Ukuthi abantu bakhathazeka kusukela kuthi yini kumthetho wamatrocars esikhathi esinye sokulapa?

Ukuchaza kwabantu bakhethe ukuthi abasemthethweni bakhathazeka kusukela kuthi yini kumthethwo wamatrocars, ikakhulu ngesikhathi sobulungiswa, ngokuchaza ukusebenzisa ngokwesibonelo ngokwesifundo sase-IEC 62366-1.

Ukubhekana kwezindawo zokuthengiswa (PMS) kukuphi futhi kungani okuphambili?

I-PMS iyisikhathi sokubheka ukusebenza kweprodukthi emizini yezinto ezinjalo, ukukhipha imininingwane ngamaphroblemi, nokuzinikela ukuthi kufakelwe ngokushesha nokulungiswa ukuze kubuyiselwe ukuthi kuyasebenza ngokulinganayo nokuphepha.