Dab tsi yog cov qauv kev nyab xeeb rau kev siv diodes hauv cov khoom siv kho mob?

Ib, Hluav Taws Xob Kev Nyab Xeeb: Kab Liab Tsis Txaus rau Kev Tswj Tam Sim No
1. Tus neeg mob to tam sim no txwv
Raws li IEC 60601-1 tus qauv, circuits hauv cov khoom siv kho mob uas tuaj rau hauv kev sib cuag ncaj qha lossis tsis ncaj nraim nrog cov neeg mob, xws li electrocardiographs, defibrillators, infusion twj, thiab lwm yam, yuav tsum nruj me ntsis tswj tam sim no. Raws li kev ua haujlwm ib txwm muaj, DC tivthaiv ntawm tus neeg mob qhov xau tam sim no yuav tsum tsis pub tshaj 10 μ A, thiab AC tivthaiv yuav tsum tsis pub tshaj 100 μ A (0Hz-1kHz). Qhov kev txwv no yog nyob ntawm qhov chaw pib kev nyab xeeb ntawm lub cev -10 μ A DC tam sim no dhau los ntawm lub plawv tuaj yeem ua rau ventricular fibrillation, thaum AC feem ntau yuav ua rau cov leeg nqaij lossis paj hlwb stimulation.

Case: Ib hom tshuaj saib xyuas tau pom tias muaj "kev pheej hmoo ncaj qha ntawm hluav taws xob poob rau cov neeg mob" thaum lub sijhawm kuaj FDA daim ntawv pov thawj vim muaj ESD diode leakage tam sim no ntau dhau ( ntsuas ntawm 35 μ A), ua rau qhov project ncua ntawm 18 lub hlis thiab poob ntau dua 10 lab US las.

2. Cov kev cai tshwj xeeb rau cov khoom siv tiv thaiv ESD
Cov cuab yeej kho mob yuav tsum xeem dhau IEC 60601-1-2 EMC xeem, nrog ESD cov cai ntawm ± 15kV tiv tauj tawm thiab ± 25kV huab cua tawm. Tom qab kev sim, qhov tso tawm tam sim no nce ntxiv ntawm ESD diode yuav tsum tsawg dua 1 μ A, thiab cov cuab yeej tsis yuav tsum tsis txhob ya. Cov neeg siv khoom siv qib ESD diodes tuaj yeem ntsib 10 npaug ntawm cov dej ntws tam sim no tom qab ESD poob siab, uas tsis tuaj yeem ua tau raws li qib kev kho mob.

Cov txheej txheem xaiv:

Cov dej xau tam sim no ntawm qib kho mob ESD diodes yuav tsum ua raws li cov cai hauv qab no: IR<0.1 μ A @ 25 ℃, IR<0.5 μ A @ 60 ℃ (operating room ambient temperature).
Piv txwv li, ASIM cov qauv kho mob tshwj xeeb ESD3V3E0017LA (DFN0603 pob) muaj qhov xau tam sim no tsuas yog 0.05 μ A ntawm 25℃thiab 0.2 μ A ntawm 60 degree, deb dua li tus qauv txwv.
3. Anti tremor tiv thaiv
Rau cov khoom siv uas tuaj yeem cuam tshuam nrog cov neeg mob, xws li defibrillators, lawv cov ESD diodes yuav tsum xeem dhau qhov kev ntsuas tiv thaiv kev tshee (xws li IEC 60601-2-27). Qhov kev ntsuam xyuas xav kom cov khoom xau tam sim no tseem ua tau raws li qhov txwv ntawm 10 μ A hauv qab 5000V high-voltage mem tes cuam tshuam, thiab tsis muaj kev tawg lossis luv luv yuav tsum tshwm sim.

2, Mechanical kev nyab xeeb: lub zog muaj zog thiab kev tiv thaiv ntawm cov khoom txav
1. Ntim kev ntseeg tau
Cov cuab yeej kho mob yuav tsum xeem dhau qhov kev ntsuas lub zog ntawm IEC 60601-1, suav nrog:

Drop test: The portable device should be dropped three times from a height of 1 meter onto a hardwood board (mass>50kg), npog tag nrho cov lus qhia ua tau thaum siv ib txwm.
Vibration test: Simulate lub vibration ib puag ncig thaum thauj los yog siv, nrog ntau zaus ntawm 10Hz-500Hz, acceleration ntawm 2g-5g, thiab lub sij hawm ntawm 2 teev.
Impact test: Ib nrab sine wave impact, ncov acceleration of 50g, duration of 11ms, three times in positive and negative directions.
Cov ntaub ntawv: Ib qho kev sojntsuam ultrasonic portable tau pom tias muaj diode ntim delamination ntawm -40℃↔ Tom qab 85℃qhov kub thiab txias cycling test, cov xau tam sim no tau nce los ntawm 0.1 μ A rau 15 μ A, uas tau txiav txim tias tsis tsim nyog.

2. Kev tiv thaiv kev txav mus los
Rau cov khoom siv uas muaj lub cev muaj zog- cov khoom siv tsav (xws li cov twj tso kua mis), lawv cov khoom txav mus los yuav tsum ua tau raws li cov hauv qab no:

Kev txwv nrawm: Qhov nrawm ntawm qhov txav yuav tsum tsis pub tshaj 2.5g kom tsis txhob muaj kev puas tsuaj rau cov neeg mob.
Kev nres thaum muaj xwm txheej ceev: Lub khawm nres thaum muaj xwm ceev yuav tsum tau muab los ntawm kev tswj lub ntsiab, thiab lub sijhawm nres yuav tsum tsawg dua 0.2 vib nas this.
Kev kuaj xyuas tus neeg mob: Yog tias cov khoom txav txav tuaj yeem cuam tshuam nrog tus neeg mob (xws li lub caj npab robotic), yuav tsum tau nruab qhov kev sib cuag sensor thiab lub zog yuav tsum nres tsis pub dhau 1 thib ob tom qab kev sib cuag.
3, Environmental adaptability: stability nyob rau hauv huab cua
1. Kev tswj kub thiab av noo
Cov cuab yeej kho mob yuav tsum ua haujlwm ruaj khov hauv ib puag ncig hauv qab no:

Qhov kub thiab txias: Cia kub -40℃- 70 degree, ua haujlwm kub 0℃- 40℃(qee yam khoom xws li cryogenic slicers yuav tsum txhawb -80℃).
Humidity ntau yam: Ua haujlwm av noo 10% mus rau 90% RH (tsis condensing), cia cov av noo 5% mus rau 95% RH (tsis condensing).
Cov ntaub ntawv: Ib qho oximeter tau ntsib qhov tsis zoo ntawm kev ntsuas qhov yuam kev los ntawm ± 2% mus rau ± 8% vim yog qhov nce ntawm cov xau tam sim no ntawm 5 μ A tom qab kev laus lub diode hauv ib puag ncig ntawm 85% RH thiab 85℃rau 1000 teev. Cov ntaub ntawv kho mob tsis tuaj yeem txheeb xyuas qhov tseeb.

2. Kev tiv thaiv corrosion thiab tiv thaiv plua plav

Kev ntsuas ntsev ntsev: Cov khoom siv siv hauv cov ntug dej hiav txwv yuav tsum dhau 48 teev ntsev tshuaj tsuag (5% NaCl tov, 35 degree) tsis muaj corrosion ntawm diode pins.
Dustproof rating: Nws yuav tsum tau raws li IP5X (dustproof) los yog IP6X (ua tiav plua plav) kom tsis txhob muaj plua plav nkag thiab ua rau luv luv Circuit Court.
4, Electromagnetic compatibility (EMC): Tsis txhob cuam tshuam thiab tiv thaiv kev cuam tshuam
1. Kev txwv tsis pub dhau
Cov khoom siv kho mob yuav tsum ua raws li CISPR 11 cov qauv, thiab lawv cov emissions (150kHz txog 30MHz) thiab hluav taws xob emissions (30MHz txog 1GHz) yuav tsum qis dua qhov txwv. Piv txwv li, cov hluav taws xob emission ntawm lub electrocardiogram saib nyob rau hauv ntau zaus ntawm 30MHz mus rau 1GHz yuav tsum tsawg dua 40dB μ V / m (10m nrug).

2. Kev tiv thaiv kab mob

Electrostatic paug (ESD): ± 15kV tiv tauj tawm, ± 25kV pa tawm. Tom qab kev sim, cov cuab yeej siv yuav tsum rov ua haujlwm li qub.
Hluav taws xob Fast Transient (EFT): ± 2kV / 5kHz, cov khoom siv tsis muaj cov ntaub ntawv poob lossis kev ua haujlwm tsis zoo tom qab kuaj.
Surge: ± 1kV rau kab rau kab thiab ± 2kV rau kab rau hauv av. Tom qab kev sim, cov cuab yeej yuav tsum dhau qhov kev xeem ua haujlwm.
Case: Vim tsis txaus surge resistance ntawm lub diode, ib tug defibrillator tau ntsib cov ntaub ntawv poob tom qab ± 2kV surge test, ua rau txawv txav defibrillation zog tso zis, uas tau txiav txim raws li "muaj kev ruaj ntseg neeg mob kev ruaj ntseg".

5, Biocompatibility: Cov kev cai tshwj xeeb rau kev sib cuag ncaj qha nrog cov neeg mob
Rau diodes uas tuaj rau hauv kev sib cuag ncaj qha nrog cov neeg mob (xws li sensor interfaces hauv implantable devices), lawv yuav tsum ua tau raws li ISO 10993 tus qauv:

Cytotoxicity: Cov ciaj sia taus ntawm cov hlwb raug ntau dua 70% (MTT assay).
Allergenicity: Tsis muaj daim tawv nqaij tawm tsam (Guinea Pig Maximization Test).
Implantation test: Tsis muaj cov ntaub so ntswg hauv zos (xws li mob thiab necrosis).
Cov ntaub ntawv: Ib qho implantable ntshav qabzib ntsuas tau rov qab los vim yog cov khoom ntim diode tsis dhau ISO 10993-5 rhiab heev kuaj, ua rau mob liab thiab o ntawm daim tawv nqaij.

6, Kev Lag Luam Ua Lag Luam: Kev Tswj Xyuas Txheej Txheem Tag Nrho los ntawm Kev Xaiv mus rau Kev Tshawb Fawb
1. Kev xaiv ntaus ntawv

Tsawg to tam sim no qhov tseem ceeb: Cov dej ntws tam sim no ntawm kev kho mob qib diodes yuav tsum tsawg dua 0.1 μ A ntawm 25 degree, thiab qhov kub coefficient yuav tsum tsawg dua 2% / degree.
Kev ntim khoom muaj kev ntseeg siab: cov txheej txheem iav passivation (xws li ESD12D080TA-AEC) yog qhov nyiam, vim nws cov dej tsis kam tiv taus zoo dua rau cov txheej txheem ib txwm muaj.
Kev kuaj kev laus: Thaum ua haujlwm tsis tu ncua rau 1000 teev ntawm qhov ntsuas hluav taws xob thiab 60℃ib puag ncig, qhov ntws tawm tam sim no yuav tsum tsawg dua 0.1 μ A.
2. Kev kuaj xyuas

Kev sim ua haujlwm: Txheeb xyuas qhov kev tiv thaiv rau pem hauv ntej thiab thim rov qab, qhov hluav taws xob tawg, thiab lwm yam kev ntsuas ntawm diode siv lub oscilloscope thiab multimeter.
Kev ntsuas ib puag ncig: suav nrog qhov kub thiab txias siab (85℃/ 85% RH), kub caij tsheb kauj vab (-40 degree) ↔ 85 degree), ntsev tsuag, thiab lwm yam.
Kev kuaj EMC: Tso cai rau peb lub chaw kuaj mob thib peb los ua cov kev sim xws li kev siv hluav taws xob, hluav taws xob emission, ESD, EFT, thiab lwm yam.
3. Muab saw hlau traceability

Original Hoobkas tso cai: Ua ntej xaiv thawj lub Hoobkas tso cai cov neeg sawv cev kom tsis txhob yuav khoom los ntawm kev tsis raws cai.
Batch traceability: Xav kom cov neeg muag khoom muab cov lej batch thiab nug cov hnub tsim khoom, cov ntaub ntawv xeem, thiab lwm yam ntaub ntawv los ntawm thawj lub Hoobkas.
Cov ntaub ntawv pov thawj: Tshawb xyuas CE, FDA, NMPA thiab lwm daim ntawv pov thawj los xyuas kom meej tias cov khoom ua tau raws li qhov yuav tsum tau ua ntawm lub khw muag khoom.