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ISO13485 is also called "medical device quality management system for regulatory requirements".
Scope of quality management system certification: Production of PCB components for electrocardiograph and endoscope.Through IS013485: 2016 certification, it not only proves that under the quality assurance system, FASTPCBA can continuously provide high-quality products that meet the needs of medical device customers, and further demonstrates our company's higher requirements for product quality standards. The successful passing of this IS013485: 2016 certification is an endorsement of our company's product quality and safety regulations aspects.
Article | Description | Capability | |
Sercive | PCB and SMT assembly with one-stop service | ||
Material | Laminate materials | FR4, high TG FR4, high frequency, alum, FPC | |
Board cutting | Number of layers | 1-48 | |
Min.thickness for inner layers (Cu thickness are excluded) | 0.003”(0.07mm) | ||
Board thickness | Standard | (0.1-4mm±10%) | |
Min. | Single/Double:0.008±0.004” | ||
4layer:0.01±0.008” | |||
8layer:0.01±0.008” | |||
Bow and twist | 7/1000 | ||
Copper weight | Outer Cu weight | 0.5-4 0z | |
Inner Cu weight | 0.5-3 0z | ||
Drilling | Min size | 0.0078”(0.2mm) | |
Drill deviation | ±0.002″(0.05mm) | ||
PTH hole tolerance | ±0.002″(0.005mm) | ||
NPTH hole tolerance | ±0.002″(0.005mm) | ||
Solder mask
| Color | Green,white,black,red,blue… | |
Min solder mask clearanace | 0.003″(0.07mm) | ||
Thickness | (0.012*0.017mm) | ||
Silkscreen | Color | white,black,yellow,blue… | |
Min size | 0.006″(0.15mm) | ||
E-test | Function Test | 100% Functional test | |
PCBA Testing | X-ray,AOI Test,Functional test | ||
Pcb assembly | one-stop service electronic manufacxturer service | ||
Component sourcing | Yes | ||
Certificate | IATF16949,ISO9001 | ||
Delivery time: | PCB | 3-12days | |
PCBA | 8-20days | ||
Tolerance of pcb | ±5% | ||
Max size of finish board | 450*450mm | ||
MOQ | NO MOQ (1pcs) | ||
Surface Finish | HASL,ENIG,immersion silver,immersion tin,OSP… | ||
PCB outline | Square,circle,irregular(with jigs) | ||
package | QFN,BGA,SSOP,PLCC,LGA | ||
Sub-assembly | Plastic,metal,screen |
FASTPCBA Technology Co., Ltd is a professional PCB manufacturer in China, Shenzhen. With 14 years of development, FASPCBA turns into a first class manufacturer of HDI PCB, with production capability 35,000 square meters. FASTPCBA is providing high quality bare PCB and PCB assembly service,including components sourcing, function test,conformal coating and complete assembly for clients all over the world.
Our aggressive business strategy enables us to deliver high competitive services for our diverse, competitive customer base. Through this strategy, we are able to make fast, flexible decisions in response to changing market conditions and create most value and benefits for customers.
As for Service, we provide 7days 24hours on-line professional Pre-sale, Selling and After-Sale service to solve any question about the order. Any time, any requirement will get Prompt Reply from our well-trained and friendly support staff.
Our main market is Europe, north USA,Australia, South America, and Asia. we will put much more effort to build connection with more customers in more area. All we want to do, is to connect the world by our products, to share the Value, Happyness and Achievement with more customers.
Certificates:
All of our PCB and PCBA are ISO, TS, RoHS and UL approved.
Quality Guarantee is the basis of our clients' trust.