Cov cuab yeej siv kho mob

Cov cuab yeej siv kho mob

FDA-Ua raws Stainless Hlau & Aluminium Enclosures rau Diagnostic & Therapeutic Equipment
SKU: ZT-MDE-020|Lub Sijhawm Lead: 20-30 Hnub rau Kev Cai Teeb Meem
304/316 stainless hlau los yog 5052 txhuas
CNC xovxwm nres thiab laser vuam kab
Diagnostic imaging Cheebtsam, cov cuab yeej saib xyuas tus neeg mob, thiab cov cuab yeej kho mob
Kev nyab xeeb ntawm tus neeg mob (kev cais hluav taws xob, tsis muaj qhov ntse ntse), kev huv huv rau kev tiv thaiv kab mob, thiab kev ua raws cai
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Kev tsis

Zento Trilium Hlau Tech Co., Ltd. Zoo siab txais tos mus yuav cov khoom siv kho mob ruaj khov ua nyob rau hauv Suav teb nov los ntawm peb lub hoobkas. Yog tias koj muaj lus nug txog kev pabcuam customized, thov koj xa email rau peb.

 

Product Summary

Medica- Device-Enclosures-cabinet

Kev kho mob- qib enclosure fabricated los ntawm 304/316 stainless hlau los yog 5052 txhuas ntawm peb CNC xovxwm nres thiab laser vuam kab ntawm Ruqing chaw.

 

Cov khoom siv hauv tsev kuaj mob, cov cuab yeej saib xyuas neeg mob, thiab cov cuab yeej kho mob hauv tsev kho mob, tsev kho mob, thiab chaw kho mob hauv tsev.

 

Qhov tseem ceeb ntawm engineering yog tus neeg mob kev nyab xeeb (kev cais hluav taws xob, tsis muaj qhov ntse ntse), kev huv huv rau kev tiv thaiv kab mob, thiab kev tswj hwm kev ua raws cai (ISO 13485 kev paub, FDA 21 CFR Tshooj 820 cov ntaub ntawv sib xyaw).

 

Cov txheej txheem tsim khoom & khoom siv

 

Medical Enclosures: Safety by Design

Cov cuab yeej siv kho mob tsis yog lub thawv xwb - lawv yogkev nyab xeeb- cov khoom tseem ceeb. Lub ntug ntse tuaj yeem ua rau tus neeg mob lossis tus kws kho mob raug mob. Ib qho chaw hauv av tsis zoo tuaj yeem ua rau hluav taws xob poob siab. Lub crevice tuaj yeem khaws cov kab mob.

Kauj Ruam 1: Kev Xaiv Cov Khoom Siv thiab Traceability
Tag nrho cov ntaub ntawv yogntau -traceablerau mill daim ntawv pov thawj. Rau 316L, peb tuaj yeem muabPositive Material Identification (PMI)pov thawj. Qhov kev taug qab no yog qhov tseem ceeb rau kev ua raws FDA 21 CFR Part 820.

Kauj Ruam 2: Fabrication nrog kev nyab xeeb hauv siab

Tsis muaj Sharp Edges:Tag nrho cov npoo nthuav tawm yogdov, hemmed, los yog radiusedtshem tawm qhov kev pheej hmoo ntawm kev txiav. Qhov no yog qhov tsis yog - qhov yuav tsum tau sib tham tau rau cov khoom siv kho mob.

Cleanable Seams:Pom seams yogtsis tu ncua laser-weldedthiab av yaug. Tsis muaj stitch welds, tsis qhib seams.

Captive Hardware:Tag nrho cov fasteners yograug ntes(tsis tuaj yeem poob tawm) lossiszaisrov qab nkag npog. Tsis muaj cov ntsia hlau xoob uas tuaj yeem ua cov khoom txawv teb chaws.

Kauj Ruam 3: Nto Finishing rau Kev Tswj Kab Mob

Stainless hlau:Electropolishing muab lub smoothest, feem ntau huv si nto (Ra tsawg dua los yog sib npaug rau 0.4μm). Nws kujpassivatesqhov saum npoo rau qhov siab tshaj plaws corrosion tiv thaiv cov tshuaj tua kab mob hnyav.

Aluminium:Peb thovantimicrobial hmoov txheejmuaj nyiaj ions (EPA{0}} npe). Qhov no inhibits cov kab mob loj hlob ntawm siab -kov nto.

Medical-Device-Enclosures

Tus Kws Kho Mob Biomedical's Near-Ntxhais: Cov Ntsiab Lus Loose Screw
Thaum lub sij hawm tsim kev tshuaj xyuas, tus kws kho mob biomedical tau hais txog qhov kev txhawj xeeb: Lub vaj huam sib luag nkag tau ruaj ntseg los ntawm M3 screws uas, yog tias loosened, tuaj yeempoob rau hauv lub cuab yeej. Hauv tus neeg mob- cov khoom siv txuas nrog, lub hau ntswj xoob yog ib qhokev poob siab.

Peb qhov kev daws teeb meem:Peb redesigned lub vaj huam sib luag nrogcaptiv screws(screws nrog nylon thaj lossis ib lub tshuab ntxhua khaub ncaws uas khaws cia rau hauv lub vaj huam sib luag). Txawm tias thaum xoob tag nrho, cov ntsia hlau tseem nyob nrog lub vaj huam sib luag. Qhov kev hloov pauv yooj yim no tshem tawm qhov teeb meem kev nyab xeeb.

Kev Nyab Xeeb Hluav Taws Xob: Kev sib tsoo thiab kev sib cais
Cov khoom siv hluav taws xob kho mob yuav tsum tau ua rawsIEC 60601-1: Kev qhia tshwj xeebcov qauv kev nyab xeeb. Peb cov enclosures muaj xws li:

Grounding studsnrog cov khoom siv xauv khoom (lub hnub qub washers) kom paub meej<0.1Ω bond

Kev cai mounting caisrau tus neeg mob- txuas circuits (nylon standoffs, insulated brackets)

Cov ntaub ntawv pobsuav nrog cov ntaub ntawv pov thawj, daim ntawv qhia kev sib txuas, thiab cov ntawv ceeb toom txuas ntxiv mus

Ntim Ntim:
Cov khoom siv kho mob xav tauhuv ntimtxhawm rau tiv thaiv kev kis kab mob thaum lub sijhawm xa khoom thiab khaws cia. Peb ntim enclosures hauv achav huv huv- thaj chaw sib haum xeebsivlint-wrapping dawbthiabvalidated ntim cov ntaub ntawv. Cov ntawv pov thawj ntawm kev huv huv muaj.

 

Quality Control & Certification

 

Edge Safety Inspection:

100% tactile tshuaj xyuas ntawm tag nrho cov npoo raug. Txhua lub ntug ntse yog tsis lees paub thiab rov ua haujlwm dua.

Grounding Continuity:

Tag nrho cov ntsiab lus hauv av raug txheeb xyuas<0.1Ω with milliohm mus. Cov ntaub ntawv ntsuam xyuas tuaj yeem taug qab tau rau tus lej xov tooj.

 

Surface Finish Verification:

Roughness:Tshawb xyuas nrogportable nto roughness tester .

Antimicrobial kev ua tau zoo:Cov hmoov txheej yog kuaj raws li ISO 22196 (yog tias tau teev tseg).

Dimensional Verification:

Qhov tseem ceeb mounting interfacestxheeb xyuas ntawmXi'an Edward CMM (0.005 hli raug) .

Cov ntaub ntawv pob:

Cov ntaub ntawv pov thawj (EN 10204 3.1)

Weld maps thiab welder tsim nyog

Cov ntawv ceeb toom txuas ntxiv mus

Certificate of Cleanness (yog tias xav tau)

ISO-9001-2015
ISO-14001-2015
ISO-45001-2018

 

Engineering Notes & FAQ

 

Q1: Koj lub chaw puas muaj ntawv pov thawj ISO 13485?

Peb ua haujlwm raws li ISO 9001: 2015 thiab ISO 13485-paub. Qhov no txhais tau tias peb nkag siab txog cov cuab yeej kho mob QMS cov cai (traceability, documentation, change control) thiab tuaj yeem tsim los txhawb koj daim ntawv pov thawj ISO 13485. Peb muab cov ntaub ntawv tsim nyog rau koj QMS.

Q2: Cov ntaub ntawv dab tsi tau sib haum nrog kev siv tshuaj tua kab mob ntau zaus siv hydrogen peroxide lossis tshuaj dawb?

316L stainless hlau nrog electropolished tiav yog tus qauv kub. Nws tiv taus pitting los ntawm chlorides (bleach) thiab peroxides. Aluminium nrog antimicrobial hmoov tsho tiv no kuj haum tab sis tej zaum yuav qhia kom hniav zoo nkauj hnav lub sij hawm. Zam 304 stainless rau tshuaj dawb -hnyav tshuaj tua kab mob- nws thiaj li yuav pit.

Q3: Kuv xav tau lub kaw lus kom tau raws li IEC 60601-1 cov kev cai tam sim no. Koj muab dab tsi?

Peb muab:
Grounding kev npaj (studs, hnub qub washers) nrog<0.1Ω continuity
Kev sib cais mounting rau tus neeg mob- txuas txuas
Cov ntaub ntawv pov thawj rau cov khoom siv hluav taws xob
Kev soj ntsuam tas mus li qhia tau traceable rau serial tooj
Kev ntsuam xyuas qhov dej xau zaum kawg yog ua los ntawm koj (tus kws tsim khoom siv) ntawm cov khoom sib dhos ua ke.

Q4: Koj puas tuaj yeem muab cov ntaub thaiv npog nrog cov ntaub ntawv pov thawj biocompatibility?

Cov ntaub thaiv npog nws tus kheej (stainless steel, aluminium) feem ntau suav tias yog biocompatible. Rau tus neeg mob-cov chaw tiv tauj, peb tuaj yeem muab cov ntaub ntawv pov thawj thiab cov ntaub ntawv txheej txheem los txhawb koj cov ntaub ntawv biocompatibility. Peb tsis ua cytotoxicity lossis sensitization kuaj- qhov no yog lub luag haujlwm ntawm cov chaw tsim khoom.

 

modular-1
Tau txais Custom Quote

Muab koj cov kev xav tau ntawm cov ntaub ntawv, cov ntaub ntawv nyiam, thiab cov ntaub ntawv tswj kev xav tau. Peb pab neeg ua haujlwm engineering yuav muab kev soj ntsuam kev ua raws cai thiab kev siv nyiaj txiag tsis pub dhau 24 teev.

 

Cov Txheej Txheem Zoo Txhawb Cov Khoom Siv no

 

  • ISO-9001-2015ISO 9001 Daim ntawv pov thawjNyem rau saib

 

workshop

Cov cuab yeej tshuaj xyuas siv rau qhov no:

Xi'an Edward CMM (0.005mm qhov tseeb) - Kev txheeb xyuas qhov cuam tshuam tseem ceeb

Milliohm Meter - Grounding continuity (<0.1Ω)

Surface Roughness Tester - Electropolished tiav validation

Zento Trilium Hlau Tech Co., Ltd Tianjin, Suav teb|info@zento-trilium.com

 

 

Technical Specifications

 

Specification

Paub meej

Cov khoom xaiv

304 Stainless hlau (Standard)
316L Stainless hlau (Ntaus tshuaj tua kab mob)
5052 Aluminium nrog antimicrobial hmoov txheej (Lub teeb yuag)

Khoom Thickness

1.0mm-1.5mm (lub cev)
1.5mm - 2.0mm (Cov tswv cuab ntawm cov qauv)

Nto tiav

Stainless: #4 Txhuam los yog Electropolished
Aluminium: Antimicrobial hmoov txheej (EPA{0}} npe)

Kev kho ntug

Tag nrho cov ntug nthuav tawmdov, hemmed, los yog radiused-tsis muaj ntug

Kev huv huv

Seamless los yog tsis tu ncua welded seams, av flush
Tsis muaj cov hlua khi rau ntawm tus neeg mob-fab qhov chaw

Kev nyab xeeb hluav taws xob

IEC 60601-1 Cov kev cai hauv av
Kev sib cais mounting rau tus neeg mob- txuas txuas

Kev tswj hwm kev paub

Cov ntaub ntawv sib xws nrog FDA 21 CFR Part 820
Cov ntaub ntawv Fabrication txhawb ISO 13485 QMS

Ntim

Ib leeg qhwv hauv cov yeeb yaj kiab tiv thaiv, kev cai ua npuas ncauj, validated huv ntim

Daim ntawv pov thawj

Raws li ISO 9001; cov ntaub ntawv pov thawj thiab cov ntaub ntawv txheej txheem muab

 

Cim npe nrov: Tuam Tshoj Medical Device Enclosures manufacturers, lwm tus neeg, Hoobkas

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