Kutheni i-17-4 Stainless Steel iyeyona ndlela ilungileyo yokukhetha izinto kwiibrakethi ze-Orthodontic?

Intshayelelo

Iibrakethi ze-Orthodontic kufuneka zibambe ubungakanani obuchanekileyo ngelixa zinyamezela uxinzelelo oluqhubekayo lokuhlafuna, i-wire torque, kunye nemijikelo yonyango ende, ngoko ke ukhetho lwezinto luchaphazela ngokuthe ngqo ukusebenza kunye nokuthembeka. Phakathi kwee-alloys ezikhoyo, intsimbi engagqwaliyo eqiniswa yimvula eyi-17-4 iyabonakala kuba idibanisa amandla aphezulu kakhulu kunye nokumelana nokugqwala okunamandla kunye nokuveliswa ngokuchanekileyo. Ezi mpawu zinceda iibrakethi ukuba zimelane nokuguquguquka, zigcine i-slot geometry, kwaye zigcine ukubonakaliswa okuzinzileyo kwe-torque eyakhelwe ngaphakathi kunye nokuhamba kwamazinyo. Ukuqonda ukuba kutheni le alloy isebenza kakuhle kangaka kunika abafundi umbono ocacileyo wendlela uyilo lwebrakethi, intuthuzelo yesigulana, kunye nokuqikelelwa kweklinikhi okudityaniswe ngayo, ukuseta izixhobo eziphambili kunye neenzuzo zonyango ezihlolwe kwinqaku eliseleyo.

Kutheni Ufanele Ukhethe Intsimbi Engagqwaliyo Eyi-17-4

Izibiyeli ze-Orthodontic ziphantsi kwamandla anzima amaninzi ngexesha lonyango, zifuna izixhobo ezibonelela ngozinzo olukhethekileyo loomatshini. Phakathi kwee-alloys ezahlukeneyo ezisetyenziswa kwimveliso ye-orthodontic, intsimbi engagqwali ye-17-4 precipitation-hardening (PH) iye yavela njengomgangatho weshishini. Eyaziwa ngokwesinyithi njengohlobo lwe-630, le ntsimbi ingagqwali ye-martensitic inika indibaniselwano enqwenelekayo yamandla aphezulu, ukumelana nokugqwala okugqwesileyo, kunye nokukwazi ukwenziwa ngokuchanekileyo.

Kwizicelo ze-orthodontic, izinto ezisetyenzisiweyo mazimelane namandla okuhlafuna kunye ne-torque eqhubekayo esetyenziswa yiii-archwiresngaphandle kokuguqulwa kweplastiki.Intsimbi engagqwaliyo eyi-17-4ifumana amandla amangalisayo okuvelisa anokudlula i-1,170 MPa (170 ksi) xa inyangwa ngokufanelekileyo ngobushushu, iqinisekisa ukuba ubukhulu obubalulekileyo be-bracket slot (ngesiqhelo iinkqubo eziqhelekileyo ze-0.018-intshi okanye i-0.022-intshi) zihlala zizinzile ngokupheleleyo kulo lonke ixesha lonyango lweklinikhi. Olu kuqina kolwakhiwo luvumela abavelisi ukuba bayile ii-brackets ezisezantsi, ezikhululekileyo ngaphandle kokubeka emngciphekweni ukunyaniseka koomatshini okufunekayo ukuze kushukume amazinyo ngempumelelo.

Iingenelo zokuthembeka kweklinikhi

Ukuthembeka kweklinikhi kwi-orthodontics kuxhomekeke ekubonakalisweni okuqikelelweyo kwe-torque (edla ngokuqala kwi--7° ukuya kwi-+22°), i-tip, kunye neentshukumo zokungena ezakhiwe kwi-bracket prescription. Xa i-bracket slot iguquka phantsi komthwalo we-archwire enzima ye-rectangular, intshukumo yamazinyo emiselweyo iyaphazamiseka, nto leyo ekhokelela kwixesha elide lonyango kunye neziphumo ezingalindelekanga. I-17-4 stainless steel ithintela le slot deformation, ivumela abavelisi ukuba bagcine ukunyamezelana okuqinileyo—okudla ngokuba nzima njenge-+/- 0.001 intshi—oku kuthetha iziphumo zeklinikhi eziqikelelweyo.

Ngaphezu koko, ukuqina kwezinto ezisetyenzisiweyo kunciphisa umngcipheko wokuqhekeka kwamaphiko okubopha ngexesha lokubopha okanye xa izigulane ziluma ngengozi ukutya okuqinileyo. Ngokunciphisa kakhulu utyelelo olungxamisekileyo kunye namazinga okungaphumeleli kwezibiyeli, i-17-4 stainless steel inika oogqirha isixhobo esithembekileyo kakhulu esixhasa amandla angaphazanyiswayo e-biomechanical ukusuka kwinqanaba lokuqala lokulinganisa ukuya kwinkcukacha yokugqibela.

Kutheni iphumelela ngaphezu kwentsimbi engagqwaliyo eqhelekileyo

Iintsimbi ze-austenitic stainless steels eziqhelekileyo, ezifana ne-304, 316L, okanye ii-alloys ezisemgangathweni ze-18-8, zisetyenziswa kakhulu kwizixhobo zonyango ngokubanzi kodwa aziphumeleli kwizicelo ze-orthodontic ezixineneyo kakhulu. Umda ophambili weentsimbi ze-stainless steels ezingama-300-series kukungakwazi kwazo ukuqina ngonyango lobushushu; zixhomekeke kuphela ekusebenzeni ngokubandayo ukuze zifumane amandla aphezulu, nto leyo edla ngokunganelanga kwiindawo ezincinci.

Ngokwahlukileyo koko, intsimbi engagqwaliyo eyi-17-4 idlula kwinkqubo yokuqina kwemvula edala isakhiwo se-martensitic esicociweyo kakhulu. Olu tshintsho lwe-metallurgical luvumela i-17-4 ukuba ifikelele kumanqanaba obunzima ukuya kuthi ga kwi-44 HRC (iRockwell Hardness Scale C), idlula kakhulu i-20-25 HRC eqhelekileyo ye-annealed 316L (ehlala ivelisa kwi-170-310 MPa kuphela). Ngenxa yoko, i-17-4 inika ubunzulu obuphezulu besakhiwo, okuvumela ukwenziwa kwezakhiwo ezincinci nezinomtsalane apho ii-alloys eziqhelekileyo ziya kuvelisa okanye zidilike phantsi kwemithwalo yeklinikhi.

Iipropati eziphambili ze-17-4 Stainless Steel

Ukusebenza okugqwesileyo kwentsimbi engagqwaliyo eyi-17-4 kwi-orthodontics kubangelwa ngokuthe ngqo kulwakhiwo lwayo oluthile lwe-metallurgical kunye nempendulo yayo ekusetyenzisweni kobushushu. I-alloy idla ngokuba ne-15.0% ukuya kwi-17.5% ye-chromium, i-3.0% ukuya kwi-5.0% ye-nickel, kunye ne-3.0% ukuya kwi-5.0% yobhedu, kunye nezixa ezincinci ze-columbium (niobium) kunye ne-tantalum. Olu xube oluchanekileyo ludala izinto ezilinganisa ukuqina koomatshini beentsimbi ze-martensitic kunye nokuqina kokusingqongileyo kweeklasi ze-austenitic.

Ukuqonda ezi mpawu kubalulekile kubavelisi bezixhobo zokuqala (ii-OEM) kunye noogqirha ngokufanayo, njengoko bengachazi nje kuphela indlela esebenza ngayo ibracket emlonyeni kodwa nendlela eveliswa ngayo, igqityiwe kwaye ihlanjululwe ngayo.

Amandla, ubulukhuni, kunye nokumelana nokuguguleka

Iimpawu zoomatshini zentsimbi engagqwaliyo eyi-17-4 zinokulungiswa ngonyango oluthile lobushushu. Kwimeko ye-H900 (ekwi-482°C / 900°F kangangeyure enye), le nto ifumana amandla okutsalwa afikelela kwi-1,310 MPa (190 ksi). La mandla agqithisileyo adibene nobunzima obuphezulu, obuthetha ngokuthe ngqo ukuxhathisa ukuguguleka okungaqhelekanga.

Kwimeko ye-orthodontics, ukumelana nokuguguleka kubaluleke kakhulu. Njengoko iingcingo zentsimbi engagqwaliyo, i-titanium, okanye i-nickel-titanium archwires zityibilika kwi-bracket slot, ukungqubana kunye nokuguguleka koomatshini kunokutshintsha ubukhulu be-slot ngokuhamba kwexesha. Ubunzima obuphezulu be-17-4 kunciphisa oku kuguguleka okurhabaxa, okuthintela i-archwire ekubopheni okanye ekuchotsheni i-slot, ngaloo ndlela kuqinisekisaiimekheniki zokutyibiliza ezikhawulezayokuyo yonke i-18 ukuya kwi-24 period yonyango eqhelekileyo.

Ukumelana nokugqwala kunye nokupholisha

Indawo engaphakathi emlonyeni idla ngokuba ne-pH etshintshatshintshayo (idla ngokuhla ngaphantsi kwe-pH 5.5 emva kokutya), umsebenzi we-enzyme, kunye nokufuma okungaguqukiyo. Umxholo we-chromium oyi-15.0% ukuya kwi-17.5% kwintsimbi engatyiwayo eyi-17-4 unceda ukwakheka komaleko we-oxide oqinileyo, ongasebenziyo okhusela isinyithi esingaphantsi kwi-oxidation kunye nokuhlaselwa yi-corrosive. Nangona i-17-4 ingenakumelana nokugqwala kancinci kune-316L, i-17-4 isebenza kakuhle kakhulu emlonyeni, ixhathisa ukungcoliswa kunye nokuwohloka ngenxa yokutya okune-asidi.

Ukongeza, uxinano kunye nolwakhiwo olufanayo lwe-17-4 kwenza ukuba ikwazi ukucoleka kakhulu. Abavelisi banokusebenzisa ukugqitywa ngobuninzi, ukupholisha ngombane, okanye ukugquma ngoomatshini ukuze bafumane uburhabaxa bomphezulu (Ra) ngaphantsi kakhulu kwe-0.2 micrometers. Olu gqibo lufana nesipili lubalulekile ekunciphiseni ukuqokelelwa kweplaque, ukuphucula ucoceko lwesigulane, kunye nokunciphisa ukulingana kokungqubana nxamnye ne-archwire.

Imigangatho efanelekileyo kunye neenkcukacha

Ukuqinisekisa ukhuseleko lwesigulane kunye nokusebenza kakuhle kwemveliso, intsimbi engagqwaliyo eyi-17-4 esetyenziswa kwi-orthodontics kufuneka ihambelane nemigangatho engqongqo yamazwe ngamazwe. Eyona nkcazelo ifanelekileyo yi-ASTM F899, iStandard Specification yeeSteels eziQokelelweyo zeZixhobo zotyando, echaza ukwakheka kweekhemikhali kunye neemfuno zoomatshini zebanga le-17-4 lezonyango.

Ukongeza, abavelisi badla ngokubhekisa kwi-ASTM A564 kwiimfuno eziqhelekileyo zentsimbi engagqwaliyo eqinisiweyo nebanda. Ukuthobela le migangatho kuqinisekisa ukuba izinto eziluhlaza azinazo izinto ezingcolileyo eziyingozi (ezifana nesalfure okanye i-phosphorus egqithisileyo, egqunywe kwi-0.030% kunye ne-0.040% ngokulandelelana) kwaye zinobume obufunekayo bokwakha ukuze ziphumelele uvavanyo lwe-ISO 10993-5 (cytotoxicity) kunye ne-ISO 10993-10 (sensitization).

17-4 Intsimbi Engagqwaliyo Xa kuthelekiswa Nezinye Izinto

Ngelixa intsimbi engagqwaliyo eyi-17-4 ilawulaisibiyeli se-orthodonticKwimarike, isoloko ivavanywa xa ithelekiswa nezinye izinto ezifana nentsimbi engagqwaliyo engama-316L, i-titanium ecocekileyo, i-cobalt-chromium (Co-Cr) alloys, kunye ne-polycrystalline alumina (ceramic). Isixhobo ngasinye sineprofayili eyahlukileyo yeempawu zoomatshini, iimpawu zobuhle, kunye neendleko zokuvelisa.

Ukukhetha izixhobo ezifanelekileyo kufuna ukulinganisela ngononophelo ukusebenza kakuhle kwezonyango, intuthuzelo yesigulana, kunye nokuba kunokwenzeka na ngokwezoqoqosho. Uthelekiso oluthe ngqo lubonisa ukuba kutheni i-17-4 isasele isisiseko esithandwayo kwiibrakethi zesinyithi ezikumgangatho ophezulu.

Iikhrayitheriya zokuthelekisa eziphambili

Xa kuthelekiswa izinto zokulungisa amazinyo, iinjineli kunye neengcali zonyango zigxila kumandla okuvelisa, ubulukhuni, i-friction coefficient, kunye nokuhambelana kwezinto eziphilayo. Amandla okuvelisa alawula ukumelana kwebracket nokuguquguquka, ngelixa ubulukhuni buchaphazela ukuguguleka kunye nokungqubana. Ukuhambelana kwezinto eziphilayo kuvavanywa ngokusekelwe kumandla ezinto zokuvelisa ukubangelwa kukunganyamezelani, ikakhulu kugxilwe ekukhutshweni kwe-nickel.

Iingenelo zokusebenza

Xa ithelekiswa nentsimbi engagqwaliyo eyi-316L, i-17-4 inika amandla okuvelisa ngaphezulu kwesithathu, nto leyo evumela iiprofayili zebracket ezincinci kakhulu (ii-mini-twins) ngaphandle kokulahlekelwa kukuqina. Xa ithelekiswa ne-titanium, i-17-4 ibonisa ubulukhuni obuphezulu kakhulu, nto leyo ethintela iingxaki ezinzima zokubopha kunye nokutshixa kwe-archwire ezidla ngokunxulunyaniswa neebracket ze-titanium ezithambileyo.

Ngaphezu koko, nangona iibrakethi zeseramikhi zibonelela ngobuhle obuphezulu, ukubuthathaka kwazo okubangelwa kukwaphuka kwamaphiko okubopha rhoqo kunye neenkqubo ezinzima zokuqhawula izibopho ezinokonakalisa i-enamel yamazinyo. Intsimbi engagqwaliyo ye-17-4 iyaziphepha ngokupheleleyo ezi mpazamo zinkulu, inika enye indlela ethambileyo kodwa ehlala ixesha elide eqinisekisa ukuba iza kuqikelelwa ngokwezonyango.

Izinto ezibalulekileyo ezitshintshiselanayo

Eyona nto iphambili enxulumene nentsimbi engagqwaliyo ye-17-4 ngumxholo wayo we-nickel. Nangona ingaphantsi kwe-316L (equlethe i-10-14% ye-nickel), i-nickel ye-3-5% kwi-17-4 isenokubangela ukuba abantu bangabi namdla kwizigulane ezisengozini. Idatha ye-Epidemiological ibonisa ukuba malunga ne-10-15% yoluntu ngokubanzi lunohlobo oluthile lwe-allergy ye-nickel.

Kwaba baguli bathile, oogqirha bamazinyo kufuneka batshintshe iibrakethi ezili-17-4 ngezinye iindlela ezingenayo i-nickel, ezifana neebrakethi ze-titanium okanye ze-ceramic, nangona zinobunzima boomatshini. Ukongeza, iibrakethi ezili-17-4 azinazo iimpawu zobuhle ezifunwa kakhulu ze-clear aligners okanye izixhobo ze-ceramic zolwimi, nto leyo ezibeka ngokuqinileyo njengezixhobo ze-biomechanical zemveli, ezisebenzayo kakhulu kunezisombululo zobuhle.

Izinto ekufuneka ziqwalaselwe kukwenziwa nokulawulwa komgangatho

Iijiyometri ezintsonkothileyo zeebrakethi zanamhlanje ze-orthodontic—ezinee-contours ezidityanisiweyo, ii-angulations ezichanekileyo ze-torque-in-base, kunye ne-undercuts zokubopha—zenza ukuba i-subtractive machining yendabuko ingasebenzi kakuhle. Ngenxa yoko, eli shishini liye lamkela ngokubanziUkubumba Inaliti Yesinyithi (i-MIM)njengenkqubo eqhelekileyo yokuvelisa iibrakethi zentsimbi engagqwali ezili-17-4.

I-MIM idibanisa ukuguquguquka koyilo lwe-plastic injection molding kunye nokuqina kwesakhiwo sesinyithi esibunjiweyo, kodwa ifuna imigaqo yokulawula umgangatho engqongqo ukuqinisekisa ukuba imveliso yokugqibela ihlangabezana nemigangatho yezonyango echanekileyo.

Iindlela zokubumba kunye nonyango lobushushu

Inkqubo ye-MIM iqala ngokuxuba umgubo wentsimbi engagqwaliyo oyi-17-4 kunye ne-thermoplastic binder ukwenza i-feedstock. Le feedstock ifakwe kwiimolds ezenziwe ngokwezifiso ukuze yenze 'inxalenye eluhlaza' enkulu malunga ne-15-20% kune-bracket yokugqibela. I-binder emva koko isuswa ngamakhemikhali okanye ngobushushu, idala 'inxalenye emdaka', ethi kamva itshiswe kwi-vacuum enobushushu obuphezulu okanye kwi-hydrogen furnace malunga ne-1,300°C.

Ngexesha lokusila, ibracket iyancipha iye kubukhulu bayo bokugqibela, ifikelela kuxinano olungaphezulu kwe-97% yezinto ezibunjiweyo (ngesiqhelo >7.5 g/cm³). Emva kokusila, iibracket ziyaqina. Unyango oluqhelekileyo lwe-orthodontics yi-Condition H900, apho iindawo zifudunyezwa ukuya kuma-482°C kangangeyure enye kwaye zipholiswe ngumoya, nto leyo eyenza ukuba zibe namandla kwaye zibe lukhuni ngakumbi xa zisetyenziswa eklinikhi.

Ukuhlolwa, ukulandelelwa, kunye nokuthobela imithetho

Ngenxa yokuba ubukhulu be-bracket slot bulawula ngokuthe ngqo intshukumo yamazinyo, ukuhlolwa kobukhulu bubalulekile kulawulo lomgangatho. Abavelisi basebenzisa ii-optical optical Coordinate Measuring Machines (CMMs) ezikwaziyo ukuqinisekisa ububanzi kunye nobunzulu be-slot ngokuchanekileyo ukuya kwi-2 microns. Umgangatho weshishini ufuna amazinga eziphene angaphantsi kwe-0.1% (<1,000 PPM) kwiintsilelo ze-slot dimension.

Ukulandelelana kwezixhobo zonyango kugunyaziswa yimigaqo yezixhobo zonyango efana naleICandelo 820 le-ISO 13485 kunye ne-FDA 21 CFR. Ibhetshi nganye yeebrakethi ze-MIM 17-4 kufuneka ilandelelwe ibuyele kwinxalenye ethile yomgubo wesinyithi ongavuthwanga. Amaxwebhu okuthobela imithetho aquka iingxelo zovavanyo lwezinto (ii-MTR) eziqinisekisa ukwakheka kweekhemikhali, iilog zesithando esitshisayo, kunye nokuhlolwa koxinano emva kokusila, ekufuneka kuqinisekiswe rhoqo uxinano lokugqibela olungaphezulu kwe-7.5 g/cm³.

Amanyathelo okufaneleka komthengisi

Kwi-OEMs ezifuna iibrakethi ezili-17-4 kubavelisi bezivumelwano, isiqinisekiso esiqinileyo somthengisi sibalulekile. Inyathelo lokuqala libandakanya ukuphonononga amandla e-MIM omthengisi, ngokukodwa ukuphonononga ukuchaneka kwezixhobo zabo kunye nolawulo lwe-sintering furnace, njengoko ukutshintsha kobushushu obuyi-10°C ngexesha lokusinta kunokubangela ukuqhekeka okungamkelekanga kobukhulu.

Abathengi kufuneka baqinisekise ubuchule bomthengisi emva kokucubungula. Oku kuquka ukuphonononga iinkqubo zabo zokuwa, ukupholisha ngombane, kunye nokuthambisa ukuqinisekisa ukuba iibrakethi ziyahlangabezana nokugqitywa komphezulu weRa < 0.2 µm ofunekayo. Okokugqibela, umthengisi kufuneka aqinisekise umntu wesithathu ukuba izinto zakhe ezigqityiweyo ze-17-4 ziyaphumelela uvavanyo lwe-ISO 10993-5 cytotoxicity kunye ne-sensitization, okuqinisekisa ukuba ii-residual MIM binders zisusiwe ngokupheleleyo.

Isikhokelo seendleko kunye nokukhethwa

Ukuthengwa ngobuchule kwezibiyeli zentsimbi engagqwaliyo ezili-17-4 kufuna ukuqonda izinto ezibangela iindleko ezihambelana nenkqubo ye-MIM kunye nexabiso leklinikhi lexesha elide elibonelelwa zizinto. Nangona ezinye izinto zinokubonelela ngeendleko eziphantsi zezinto eziluhlaza okanye iingenelo zobuhle obuncinci, i-17-4 imele ibhalansi efanelekileyo yokwenziwa, ukuqina, kunye noqoqosho lweyunithi.

Kubasasazi bamazinyo, ii-OEM, kunye nabathengi bezonyango, ukuhamba ngomxokelelwane wokubonelela ngezi zibiyeli kuthetha ukuvavanya utyalo-mali lwezixhobo kwangaphambili xa kuthelekiswa nokonga okukhulu kwimveliso.

Ixabiso xa lithelekiswa nexabiso lexesha elide

Ixabiso lezinto eziluhlaza ze-17-4 MIM feedstock ngokubanzi liqala kwi-$15 ukuya kwi-$25 ngekhilogram. Ngenxa yokuba ibracket enye ye-orthodontic inobunzima obuyi-gram (ngesiqhelo yi-0.1 ukuya kwi-0.3 grams), ixabiso lezinto eziluhlaza ngeyunithi nganye alinamsebenzi. Iindleko zokwenyani zizixhobo zokubumba ngenaliti, inkqubo yokusila enamandla kakhulu, kunye nokulungiswa okucokisekileyo emva kokugqitywa kwezonyango.

Nangona kunjalo, ixabiso leklinikhi eliveliswa ziibrakethi ezili-17-4 lingaphezulu kakhulu kweendleko zokwenziwa kwazo.

Izinto ezibalulekileyo ekufuneka ziqwalaselwe

• Izigqibo ezibalulekileyo kunye nesizathu sokuba Kutheni i-17-4 Stainless Steel yeyona nto ilungileyo kwiibrackets ze-Orthodontic?
• Iinkcukacha, ukuthobela imithetho, kunye nokuhlolwa komngcipheko okufuneka kuqinisekiswe ngaphambi kokuba uzibophelele
• Amanyathelo alandelayo asebenzayo kunye nezilumkiso abafundi abanokuzisebenzisa ngoko nangoko

Imibuzo ebuzwa qho

Kutheni intsimbi engagqwaliyo eyi-17-4 ikhethwa kwiibrakethi ze-orthodontic?

Inika amandla aphezulu, ubulukhuni obunyangwa bubushushu, kunye nokumelana nokugqwala, inceda ii-bracket slots zigcine imo yazo kwaye zinike intshukumo yamazinyo enokuqikelelwa ngakumbi.

I-stainless steel eyi-17-4 ithelekiswa njani ne-304 okanye i-316L yeebrakethi?

I-17-4 inokuba lukhuni xa imvula ingena, ngoko ke inamandla kakhulu kwaye ayigugi ngaphezu kweentsimbi ezisetyenziswa kakhulu ezisebenzisa i-stainless steels ezingama-300 ezisetyenziswa kwiindawo ezinoxinzelelo oluphantsi.

Yeyiphi inzuzo yeklinikhi evela ekuzinzeni okungcono kwe-slot?

Ubukhulu besloti ezinzileyo buphucula ukubonakaliswa kwe-torque, bunciphisa ukuguquguquka ngeengcingo eziziingxande, kwaye bunceda ukunciphisa ukulibaziseka okubangelwa kukungasebenzi kakuhle kwebracket.

Ngaba intsimbi engagqwaliyo eyi-17-4 iyanceda ekunciphiseni ukwaphuka kwezibiyeli?

Ewe. Ukuqina kwayo kunye nobunzima bayo kunciphisa umngcipheko wokuqhekeka nokuguguleka kwephiko lentambo, nto leyo enokunciphisa ukutyelela okungxamisekileyo ngexesha lonyango.

Ngaba iDenrotary inazo izibiyeli ze-orthodontic zentsimbi engagqwali ezili-17-4?

Ewe. I-Denrotary inezibiyeli ze-MIM 17-4 zentsimbi engagqwaliyo kwaye ivelisa iimveliso ze-orthodontic phantsi kweenkqubo zomgangatho we-CE, FDA, kunye ne-ISO13485.