Imigangatho yamazwe ngamazwe yeHemodialysis Consumable

I-Hemodialysis lunyango olusindisa ubomi kwizigulane ezinokusilela kwezintso, kwaye umgangatho wezinto ezisetyenziswayo ezisetyenziswa kwinkqubo udlala indima ebalulekileyo ekuqinisekiseni ukhuseleko lwesigulane kunye nokusebenza konyango. Kodwa ngaba ababoneleli bezempilo kunye nabavelisi banokuqinisekisa njani ukuba ezi mveliso zihlangabezana nemigangatho ephezulu yokhuseleko kunye nokusebenza? Kulaphoizinto ezisetyenziswayo hemodialysisimigangathoyiza ekudlaleni. Ukuqonda eziimimiselo yamazwe ngamazweinokunceda iikliniki, izibhedlele, kunye nabathengisi bagcine elona nqanaba liphezulu lokhathalelo.

Kutheni iMigangatho ibalulekile kwiHemodialysis Consumables?

Izixhobo zonyango kunye nezinto ezisetyenziswayo kwi-hemodialysis kufuneka zihlangabezane neemfuno ezingqongqo zokulawula ukuqinisekisabiocompatibility, ukuqina, inzala, kunye nokusebenza kakuhle. Ekubeni i-dialysis inxibelelana ngokuthe ngqo nomsinga wegazi lomguli, nakuphi na ukuthotywa komgangatho kunokukhokelela kwiingozi ezinzulu zempilo, kuquka ukosuleleka, ukosuleleka kwegazi, okanye ukususwa kwetyhefu engafanelekanga.

Ngokubambelela kwinto eyaziwayoimigangatho yokusetyenziswa kwe-hemodialysis, ababoneleli bezempilo banokuzithemba ukuba iimveliso abazisebenzisayo zidibana namanqanaba aphezuluukhuseleko, ukuthembeka, kunye nokusebenza kakuhle. Le migangatho ikwanceda abavelisi baveliseizinto ezihambelanayo, ezikumgangatho ophezuluezithobela imimiselo yokhathalelo lwempilo yehlabathi.

ImiGangatho ePhambili yaMazwe ngaMazwe yeHemodialysis Consumables

Imibutho emininzi yamazwe ngamazwe iseka kwaye ilawule imigangatho yeizinto ezisetyenziswayo hemodialysis, eqinisekisa ukuba ahlangabezana ngqongqoukusebenza, imathiriyeli, kunye neemfuno zokhuseleko. Eminye yemigangatho ebalulekileyo ibandakanya:

1. ISO 23500: Amanzi kunye ne-Dialysis Umgangatho we-Fluid

Ukucoceka kwamanzi kubalulekile kwi-hemodialysis, njengoko amanzi angcolileyo anokungenisa izinto eziyingozi kwigazi lomguli.ISO 23500inikeza izikhokelo zokulungiswa kunye nomgangatho we-dialysis fluids, ukuqinisekisa ukuba ukungcola okufana neebhaktheriya, isinyithi esinzima, kunye ne-endotoxins iyancitshiswa.

2. ISO 8637: I-Bloodlines kunye ne-Extracorporeal Circuits

Lo mgangatho ubandakanyahemodialysis bloodlines, izihlanganisi, kunye neenkqubo zetyhubhu, ukuqinisekisa ukuhambelana kwabo kunye noomatshini be-dialysis kunye nokuthintela ukuvuza okanye ukusuleleka. Izinto ezisetyenziswayo kufuneka zibenon-toxic, biocompatible, kwaye ihlala ixesha elideukumelana noxinzelelo oluphezulu lwegazi.

3. ISO 11663: Igxininisa kwiHemodialysis

I-dialysis igxininisa indima ebalulekileyo ekususeni i-toxins egazini.ISO 11663iseka imilinganiselo yolawulo lomgangatho kwezi zigxininisi, iqinisekisa ukwakheka kweekhemikhali ezifanelekileyo kunye nobunyumba ukuthintela ukwenzakala kwesigulane.

4. ISO 7199: Ukusebenza kweDialyzer kunye noKhuseleko

IiDialyzers, ezikwaziwa ngokuba zizintso ezenziweyo, kufuneka zihluze inkunkuma ngokufanelekileyo ngaphandle kokwenza umonakalo wegazi okanye ukusabela komzimba.ISO 7199ichaza iimfuno zokusebenza, iinkqubo zovavanyo, kunye neendlela zokuvala inzala ukuqinisekisaukususwa kwe-toxin engaguqukiyokwayeukhuseleko lwesigulane.

5. I-US FDA 510 (k) kunye nokuMakisha kwe-CE

Kwiimveliso ezithengiswa kwiAmazwe Amanyene kwayeudibano lwaseyurophu, i-hemodialysis consumables kufuneka ifumaneI-FDA 510(k) imvumeokanyeCE isiqinisekiso. Ezi mvume ziqinisekisa ukuba iimveliso ziyadibanaumgangatho ongqongqo, imathiriyeli, kunye nemigangatho ye-biocompatibilityngaphambi kokuba zithengiswe kwaye zisetyenziswe kwiindawo zeklinikhi.

Ukuqinisekisa ukuThotyelwa kweMigangatho ye-Hemodialysis Consumables

Intlanganisoimigangatho yokusetyenziswa kwe-hemodialysisifuna indibaniselwano yeuvavanyo olungqongqo, ulawulo lomgangatho, kunye nokuthotyelwa kwemithetho. Nantsi indlela abavelisi kunye nababoneleli bezempilo abanokuqinisekisa ukuba basebenzisa ezona mveliso zikhuselekileyo nezisebenzayo:

1. Umthombo ovela kuBavelisi abaQinisekisiweyo

Soloko ukhetha ababoneleli ukubababambelele kwi-ISO kunye ne-FDA / CE imimiselo. Abavelisi abaqinisekisiweyo balandela izikhokelo ezingqongqo zokuvelisa ukuhambisa izinto ezikumgangatho ophezulu, ezinokuthenjwa.

2. Ukuqhuba uVavanyo loMgangatho rhoqo

Inkqubouvavanyo kunye nokuqinisekiswayezinto ezityiwayo ziqinisekisa ukuba ziyaqhubeka nokuhlanganaubunyumba, ukuqina, kunye neemfuno zokusebenza. Oku kubandakanya uvavanyo lweungcoliseko lwebhaktheriya, imfezeko yezinto eziphathekayo, kunye nokungaguquguquki kweekhemikhali.

3. Ukuqeqesha abaBoneleli bezeMpilo ngokuSetyenziswa ngokuKhuselekileyo

Nokuba ezona zinto zisetyenziswayo zingcono kakhulu kufuneka ziphathwe ngokuchanekileyo ukuqinisekisa ukhuseleko lwesigulane. Ngokufanelekileyouqeqesho lokuvala inzala, ukugcinwa, nokuphathakunokunciphisa umngcipheko wosulelo kunye nokusilela kwezixhobo.

4. Ukubeka iliso kuHlaziyo loLawulo

Imigangatho yezonyango iyaguquka ngokuhamba kwexesha njengoko uphando olutsha kunye neteknoloji ivela. Ukuhlala unolwazi malunga neimimiselo yamva nje kunye nenkqubela phambiliiqinisekisa ukuba ababoneleli bezempilo kunye nabavelisi bayaqhubeka behlangabezana nemigangatho ephezulu.

Ikamva le-Hemodialysis Consumable Standards

Njengoko iteknoloji ihambela phambili,imigangatho yokusetyenziswa kwe-hemodialysisziyaphuhla ziphucukaukhuseleko lwesigulane, ukusebenza kakuhle konyango, kunye nokuzinza. Uphuhliso lwexesha elizayo lunokubandakanya:

•Abenzi boluvo abakrelekrelekwiisekethe ze-dialysis zokubekwa kweliso ixesha lokwenyani

•Izinto ezigudiswayo okanye ezinokuphinda zisetyenzisweukunciphisa impembelelo yokusingqongileyo

•Ukuphuculwa kweembrane zokuhluzaukususwa kwe-toxin ephuculweyo kunye nokuhambelana kwegazi

Ngokuhlala phambi kwezi zinto zintsha, ishishini lezempilo lingaqhubeka nokuphuculaumgangatho wonyango lwe-hemodialysiskunye neziphumo zesigulane.

Ukuqukumbela

Ukubambelela kwiimigangatho yezizwe ngezizwe yehemodialysis consumablesibalulekile ekuqinisekiseniekhuselekileyo, esebenzayo, kwaye ekumgangatho ophezulu unyango dialysis. Nokuba ungumnikezeli wezempilo, umboneleli, okanye umenzi, ukuqonda kunye nokuthobela le migangathoukuphucula ukhuseleko lwesigulane, ukwandisa ukusebenza kwonyango, kunye nokugcina ukuthotyelwa kwemithetho.

Ukuze ufumane isikhokelo kwiezikumgangatho ophezulu hemodialysis consumables, Sinomedulapha ukunceda. Qhagamshelana nathi namhlanje ukuze uhlolisiseizisombululo ezithembekileyo nezithobelayokwiimfuno zakho ze-dialysis.