Indlela Yokukhetha Izibani Zokuhlinzwa: Umhlahlandlela Ophelele Wesitifiketi se-CE, ISO 13485 kanye ne-FDA Wokuthengwa Kwezibhedlela

Umbhali: Ithimba Lobunjiniyela Bezokwelapha laseMicare | Kushicilelwe: Agasti 13, 2026

Uma ithimba lokuthengwa kwempahla esibhedlela lihlola izinhlelo zokukhanyisa ngokuhlinzwa, isitifiketi sokulawula siyindawo yokuhlola yokuqala - futhi engaxoxiswana ngayo -. Isibani sokuhlinzwa ngaphandle kwesitifiketi esifanele akuyona nje ingozi yokuthenga; kuyisibopho sokuphepha kwesiguli.

Lo mhlahlandlela uchaza kahle ukuthi yiziphi izitifiketi ezibalulekile, ukuthi ngayinye ifunani, nokuthi ungaqinisekisa kanjani ukuthobela imithetho komhlinzeki ngaphambi kokusayina i-oda lokuthenga.

Kungani Isitifiketi Sibaluleke Kakhulu Kunokuba Amashidi Okucacisiwe

Izibani zokuhlinzwa zisebenza ezindaweni ezibucayi lapho ukwehluleka kungeyona inketho. Izinhlangano ezilawulayo e-US, eYurophu, nakwamanye amazwe sezisungule izinhlaka zokuqinisekisa eziqinisekisa:

• Ukuphepha kukagesi — ukuvimbela ukushaqeka, umlilo, noma ukuphazamiseka kukagesi neminye imishini ye-OR
• Ukuphepha kwe-Photobiological — ukuqinisekisa ukuthi ukukhanya kwamaza okukhanya akubangeli umonakalo we-retina kumaqembu okuhlinzwa ngesikhathi sezinqubo ezinde
• Ukuthembeka kwemishini — ukuqina kwengalo, izilinganiso zomthwalo wokuxhumana, kanye nokuphepha kokumiswa
• Ukuhambisana kokungabi namagciwane — izinto ezingamelana nokuhlanzwa okuphindaphindiwe ngezibulala-magciwane zezinga lesibhedlela

Ishidi lemininingwane elibonisa ukuthi “160,000 lux” alisho lutho uma ukukhanya kungakahlolwa ku-IEC 60601-2-41 — indinganiso yamazwe ngamazwe echaza ngqo ukuthi izibani zokuhlinzwa kumele zisebenze kanjani nokuthi lelo nani le-lux kumele lilinganiswe kanjani.

Izinhlaka Ezintathu Ezinkulu Zokuqinisekisa

1. Imvume ye-FDA (Imakethe yase-United States)

Izibani zokuhlinzwa ezithengiswa e-United States kumele zithole imvume ye-FDA 510(k) nge-Center for Devices and Radiological Health (CDRH). Ikhodi yomkhiqizo yi-FSY (Umthombo Wokukhanya Kokuhlinzwa).

Okudingwa yi-510(k):

• Ukubonakaliswa kokulingana okukhulu nedivayisi yesibikezelo esivele sikhona emakethe yase-US
• Ukuhlolwa kokusebenza ngaphansi kwe-IEC 60601-1 (Ukuphepha Okujwayelekile) kanye ne-IEC 60601-2-41 (Izidingo ezikhethekile zezibani zokuhlinzwa)
• Ukuhlolwa kokuhambisana kwe-electromagnetic (EMC) ngokwe-IEC 60601-1-2
• Ukulethwa kwemibhalo yobuchwepheshe, ukulebula, kanye nemibiko yokuhlolwa ku-FDA

Indlela yokuqinisekisa: VakashelaIdathabheyisi Yesaziso Se-FDA 510(k) Sangaphambi Kwemakethebese usesha ngegama lenkampani noma ikhodi yomkhiqizo i-FSY. Inombolo esemthethweni engu-510(k) (ifomethi: K######) izobonisa umfakisicelo, igama ledivayisi, usuku lwesinqumo, kanye nokusetshenziswa okuhlosiwe.

⚠️ Ifulegi elibomvu: Umhlinzeki othi “uvunyelwe yi-FDA” ngedivayisi yezokwelapha yeSigaba II. I-FDA isula (ayiwamukeli) amadivayisi angu-510(k). Uma umhlinzeki engakwazi ukunikeza inombolo ye-K, cela amadokhumenti — uma engakwazi ukuwakhiqiza, ungaqhubeki.

Imithombo ebalulekile ye-FDA:accessdata.fda.gov— isizindalwazi esingasesheka sawo wonke amadivayisi asuliwe.

2. Ukumaka kwe-CE (Izimakethe ze-European Union kanye ne-EEA)

Uphawu lwe-CE (i-Conformité Européenne) luyimpoqo ezibanini zokuhlinzwa ezithengiswa e-EU kanye nase-European Economic Area. Ngaphansi koMthethonqubo Wedivayisi Yezokwelapha we-EU (MDR 2017/745), owathatha indawo ye-MDD endala ngoMeyi 2021, izibani zokuhlinzwa zihlukaniswa njengamadivayisi e-Class IIa.

Lokho i-CE MDR 2017/745 ekudingayo:

• Imibhalo yobuchwepheshe ekhombisa ukuhambisana Nezidingo Zokuphepha Nokusebenza Okujwayelekile (GSPR) ku-Annex I
• Umbiko Wokuhlola Emtholampilo (CER) — ngisho nakumadivayisi angahlaseli, umenzi kumele abonise ubufakazi bezokwelapha
• Uhlelo Lokuphatha Ikhwalithi oluqinisekiswe yi-ISO 13485:2016 yiNhlangano Eyaziswayo
• Isimemezelo Sokuhambisana esisayinwe nguMmeli Ogunyaziwe we-EU uma umenzi engaphandle kwe-EU
• Ukubhaliswa kusizindalwazi se-EUDAMED (ukuqaliswa ngezigaba; okwamanje kuyimfuneko ye-UDI kanye nokubhaliswa kwabadlali)

Indlela yokuqinisekisa:

1. Cela iSimemezelo Sokuhambisana (i-DoC) — kumele ibhale uhlu lomthethonqubo othize we-MDR, igama le-Notified Body kanye nenombolo ye-ID, kanye nokuhlukaniswa komkhiqizo.
2. Qinisekisa Umzimba Owaziswayo ku-Isizindalwazi se-NANDO seKhomishini yaseYurophu.
3. Hlola ukuthi i-DoC isayinwe yi-EU Authorized Representative uma umenzi engekho kwi-EU.

⚠️ Ifulegi elibomvu: Uphawu lwe-CE olungenayo inombolo yoMzimba Eyaziswayo. Kumadivayisi e-Class IIa, ukuziveza kokuhambisana akuvunyelwe ngaphansi kwe-MDR. Uphawu lwe-CE olunesiginesha yomkhiqizi kuphela futhi olungenayo inombolo ye-NB aluhambisani nemithetho.

3. ISO 13485:2016 — Uhlelo Lokuphatha Ikhwalithi

I-ISO 13485 akuyona isitifiketi somkhiqizo — iyisitifiketi sesistimu yekhwalithi yokukhiqiza. Kodwa-ke, yile:

• Kuyadingeka njengesisekelo sokumaka i-CE ngaphansi kwe-MDR
• Okulindeleke yiminyango yokuthengwa kwempahla ezibhedlela njengobufakazi bokulawulwa kwenqubo yokukhiqiza
• Isisekelo lapho iMibutho Eyaziswayo ihlola khona umenzi ngaphambi kokunikeza imvume yamadokhumenti obuchwepheshe

Lokho okufakwa ukuhlolwa kwe-ISO 13485:

• Izilawuli zokuklama nokuthuthukiswa (ukulandeleka kusukela ekucacisweni kuya kumkhiqizo oqediwe)
• Iziqu zomhlinzeki kanye nokuhlolwa okuzayo
• Ukuqinisekiswa kwenqubo yokukhiqiza
• Izinhlelo zokulungisa nokuvimbela (i-CAPA)
• Ukuqapha nokusingatha izikhalazo ngemuva kwemakethe

Indlela yokuqinisekisa: Cela isitifiketi samanje se-ISO 13485. Hlola ukuthi sikhishwe yinhlangano eqinisekisiwe yesitifiketi (bheka uphawu lwe-IAF MLA lwenhlangano yesitifiketi), sihlanganisa ububanzi bomkhiqizo obufanele, futhi sinosuku lokuphelelwa yisikhathi olusebenzayo.

I-IEC 60601-2-41: Izinga Lobuchwepheshe Elingemuva Kwezitifiketi

Zonke izinhlaka zesitifiketi ezingenhla zibhekisela ku-IEC 60601-2-41:2022, indinganiso yamazwe ngamazwe enesihloko esithi"Imishini kagesi yezokwelapha - Ingxenye 2-41: Izidingo ezikhethekile zokuphepha okuyisisekelo kanye nokusebenza okubalulekile kwezibani zokuhlinzwa kanye nezibani zokuxilongwa."

Le nqubo ichaza:

Isibani sokuhlinzwa esihlolwe futhi saqinisekiswa yi-IEC 60601-2-41 yilabhorethri egunyaziwe yomuntu wesithathu sizoqinisekiswa yilezi zinhlaka - hhayi ukuthi sizibike.

Umehluko obalulekile: “Kuhlolwe ku-IEC 60601-2-41″ yilabhorethri yomkhiqizi uqobo ≠ “kuqinisekiswe ku-IEC 60601-2-41″ yi-CB egunyaziwe (i-Certification Body). Cela njalo umbiko wokuhlolwa womuntu wesithathu, hhayi nje ishidi lemininingwane.

Izinga le-IEC lishicilelwe yi-International Electrotechnical Commission. Yithole ku-isitolo sewebhu.iec.ch.

Ukuqhathaniswa Kwesitifiketi Ngemakethe

Imibuzo Eyisikhombisa Okufanele Uyibuze Noma Yimuphi Umhlinzeki Wezibani Zokuhlinzwa

Ngaphambi kokusayina isivumelwano sokuthenga, cela izimpendulo ezibhaliwe zalokhu okulandelayo:

1. "Sicela unikeze inombolo yakho engu-510(k) K (yabathengi base-US) noma inombolo yakho yokuhlonza ye-CE Declaration of Conformity with Notified Body (yabathengi base-EU)."
2. "Ubani owenze ukuhlolwa kwakho kwe-IEC 60601-2-41 — ilebhu yakho yangaphakathi noma ilebhu ye-CB egunyaziwe evela eceleni? Sicela unikeze umbiko wokuhlolwa."
3. "Iyini inhloso yesitifiketi sakho se-ISO 13485:2016? Ingabe sihlanganisa ukuklama nokuthuthukiswa, noma ukukhiqiza kuphela?"
4. "Ubani uMmeleli wakho Ogunyaziwe we-EU?" (Kuyadingeka kubakhiqizi abangewona abe-EU abathengisa e-EU)
5. "Iyini inqubo yakho yokuqapha ngemuva kwemakethe? Ingabe unayo uhlelo lwe-Medical Device Vigilance olusebenzayo?"
6. "Ingakanani isikhathi sokuphila esilinganisiwe semojuli ye-LED, futhi iyini inqubomgomo yewaranti ekukhanyeni okuphumayo?"
7. "Singakwazi yini ukuhlela ukuhlolwa kwemboni, noma ingabe indawo yakho ibhaliswe kunoma yiziphi izinhlangano ezifanelekayo zezinsizakalo zesibhedlela ezifana ne-Achilles, i-Avetta, noma i-DUNS ziqinisekisiwe?"

Umhlinzeki ongakwazi ukuphendula imibuzo 1-4 ngokucacile nangokubhala akufanele adlulele ohlwini lwakho lwabathengisi oluvunyiwe.

Indlela iMicare Ebhekana Ngayo Nokuthobela Imithetho

I-Micare Medical ibilokhu ikhiqiza izinhlelo zokukhanyisa ngokuhlinzwa kusukela ngo-2007 esikhungweni sethu eNanchang, eShayina. Imikhiqizo yethu yile:

• Ibhaliswe yi-FDA — indawo yethu kanye nomugqa wemikhiqizo yokukhanya kokuhlinzwa kubhaliswe ne-US Food & Drug Administration
• Iqinisekiswe yi-CE ngaphansi kohlaka lwe-EU Medical Device Regulation (MDR 2017/745)
• Kwenziwe ngaphansi kohlelo lokuphatha ikhwalithi lwe-ISO 13485:2016
• Kuhlolwe ngokwe-IEC 60601-2-41 ukuze kutholakale ukukhanya, ukuboniswa kombala, kanye nemingcele yokuphepha kagesi
• Kutholakala nemibiko yokuhlola evela eceleni kanye nemibhalo ephelele yokuthobela imithetho yezidingo ezithile zemakethe eziqinisekisiwe

Kumaqembu okuthenga ezibhedlela adinga amaphakheji aphelele emibhalo yobuchwepheshe — kufaka phakathi isiqinisekiso sokubhaliswa kwe-FDA, iSimemezelo Sokuhambisana, isitifiketi se-ISO 13485, kanye nemibiko yokuhlola ye-IEC 60601-2-41 — xhumana nethimba lethu lokuthengisa kwamanye amazwe ku-info@micare.cnnoma ngokusebenzisasurgicallight.com/contact-us.

Imibuzo Evame Ukubuzwa

U: Ingabe ukumakwa kwe-CE kwanele ukuthengisa izibani zokuhlinzwa e-UK ngemuva kwe-Brexit? Impendulo: Cha. Kusukela ngoJanuwari 1, 2021, i-UK idinga ukumakwa kwe-UKCA (UK Conformity Assessed) kwamadivayisi ezokwelapha abekwe emakethe yase-UK. Amadivayisi amakwe nge-CE abe nesikhathi sokushintsha, kodwa abakhiqizi manje kumele bathole ukumakwa kwe-UKCA nge-UK Approved Body. Izindinganiso zobuchwepheshe zihlala zihambisana nezidingo ze-EU MDR.

U: Ingabe isibhedlela e-US singathenga isibani sokuhlinzwa esine-CE marking kuphela? Impendulo: Cha. Kudingeka imvume ye-FDA 510(k) yezibani zokuhlinzwa ezithengiswayo futhi ezithengiswayo e-United States. Ukumaka kwe-CE akwanelise izidingo ze-FDA. Lezi zinhlelo ezimbili zidinga izinhlelo zokusebenza ezihlukene kanye nemibhalo yokuhlola ehlukile, yize ukuhlolwa okuningi kobuchwepheshe okuyisisekelo (uchungechunge lwe-IEC 60601) kufana.

U: Uyini umehluko phakathi kwe-FDA 510(k) kanye ne-FDA PMA? A: Izibani zokuhlinzwa (ikhodi yomkhiqizo i-FSY) zingamadivayisi eSigaba II futhi ngokuvamile zisulwa ngendlela ye-510(k), okudinga ukuboniswa ukulingana okukhulu nedivayisi ebikezelayo ethengiswa ngokusemthethweni. I-PMA (Ukuvunyelwa Kwangaphambi Kwemakethe) igcinelwe iSigaba III, amadivayisi anobungozi obukhulu (isb., amadivayisi enhliziyo angafakwa) futhi idinga idatha yesilingo somtholampilo. Ngeke ubone izibani zokuhlinzwa zidlula ku-PMA ngaphansi kwezimo ezijwayelekile.

U: Kufanele iqinisekiswe kangaki i-ISO 13485? A: Izitifiketi ze-ISO 13485 zisebenza iminyaka emithathu, kanti ukuhlolwa kokuqapha okuphoqelekile kuminyaka yokuqala neyesibili. Ekupheleni komjikelezo weminyaka emithathu, kudingeka ukuhlolwa okuphelele kokuqinisekiswa. Hlola njalo usuku lokukhishwa kwesitifiketi kanye nosuku lokuphelelwa yisikhathi lapho ubuyekeza imibhalo yomhlinzeki.

U: Yikuphi ukukhanya okuncane okudingekayo ukuze kutholakale ukukhanya kokuhlinzwa egumbini lokuhlinza? A: I-IEC 60601-2-41 icacisa okungenani ukukhanya okungu-40,000 lux enkabeni yensimu yokukhanya, okulinganiselwa kumitha eli-1 ukusuka ekhanda lokukhanya. Kokuhlinzwa okujulile okuyinkimbinkimbi (isb., isisu, isifuba), izibani ezinikeza ukukhanya okungu-80,000–160,000 okunombala omuhle (Ra ≥ 90) ziyathandwa. Njalo qinisekisa ukuthi amanani e-lux alinganiswa ngokwendlela ye-IEC 60601-2-41, hhayi ukulinganisa kwensimu ekhululekile.

Isifinyezo

Ukukhetha isibani sokuhlinzwa esiqinisekisiwe kudinga ukuqinisekisa amadokhumenti emazingeni amathathu:

1. Ukugunyazwa kwemakethe — i-FDA 510(k) yase-US; i-CE ngaphansi kwe-MDR 2017/745 yaseYurophu
2. Ikhwalithi yokukhiqiza — ISO 13485:2016 evela kuMgwamanda Oqashelwayo noma i-CB
3. Ukusebenza komkhiqizo — Imibiko yokuhlolwa komuntu wesithathu eya ku-IEC 60601-2-41

Amashidi emininingwane kanye nezimangalo zokumaketha akuzona izinto ezithatha indawo yamadokhumenti okuhambisana nomthetho aqinisekisiwe. Umhlinzeki onokwethenjelwa uzohlinzeka ngazo zonke izigaba ezintathu zamadokhumenti ngaphandle kokungabaza.

Uma unemibuzo mayelana nemibhalo yethu yesitifiketi noma ukucela iphakheji yedatha yobuchwepheshe yokuhlolwa kokuthengwa kwakho, vakashelai-surgicallight.comnoma xhumana nethimba lethu ku-info@micare.cn or surgicallight.com/contact-us.

Izinkomba:

• Ukuphathwa Kokudla Nezidakamizwa e-US. Idathabheyisi Yezaziso Zangaphambi Kwemakethe engu-510(k).accessdata.fda.gov
• IKhomishini YaseYurophu. Umthetho Wedivayisi Yezokwelapha we-EU 2017/745. Ijenali Esemthethweni ye-EU.
• IKhomishini Yobuchwepheshe Bogesi Yomhlaba Wonke. I-IEC 60601-2-41:2022 — Izibani Zokuhlinza.isitolo sewebhu.iec.ch
• ISO. ISO 13485:2016 — Amadivayisi ezokwelapha — Izinhlelo zokuphatha ikhwalithi.iso.org
• IKhomishini YaseYurophu. I-NANDO — Izinhlangano Eziqanjwe Ngendlela Entsha.ec.europa.eu