Electronic Circuit Board EMS PCB Assembly For Medical Equipment UL 94v0 ISO13485

Product Specification

Electrical circuits manufacturing service for medical equipment with UL 94v0 ISO13485

ISO13485:2016
The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. As such we strictly adhere to our quality system to ensure we consistently design, develop and produce the medical devices with regularized guideline.

IBE has been serving the contract manufacturing (OEM/EMS) industry nearly 20 years based in China. The service includes Electronic Design , PCB Fabrication, SMT and PCB Assembly, Components Sourcing, Prototyping, Box Build, and Turnkey Solution. To expand the business and provide better services to North American customers, IBE opened a new facility IBE (USA) in Fremont,CA since 2017, which can provide a full range of PCB assembly service. Also established the facility campus in Vietnam since 2020.IBE continues to invest in new technologies, providing a complete manufacturing solution to meet customers' needs and make the process more economical. Our major products are in markets of Smart Home Appliance,Smart Metering,Medical Facility,Automotive Electronic Device,Electromobile Power Charging Electronic Device, Digital Earphone,etc.

FAQ:

1.How does a printed circuit board assembly (PCB assembly) work?

The primary function of a PCB assembly is to integrate the electronic components of a device into a compact or defined space. Acting as the central hub of the electronic circuit of a device, the PCB provides insulation for all other electrical components, allowing them to be safely connected to a power source.

2. What information is required for a turnkey PCB assembly order?

For turnkey projects, we’ll need the following:

Gerber file

Bill of materials (BOM)

Component placement list (CPL)

All relevant CAD and .stp file

3. Are you UL / Underwriters Laboratory approved?

IBE pursues all applicable UL certifications for our products, and we offer several products certified with UL and CSA based on customer’s demand

Underwriters Laboratories (UL) grants multiple certifications, including:

IBE is certified for PCB by UL file E326838

4. Do you offer RoHS&REACH-compliant assemblies?

Yes, IBE does offer assemblies that comply with the European Union’s Restriction of Hazardous Substances (RoHS) Directive and REACH.

5. Do you offer testing and inspection services?

Yes, IBE offers a comprehensive list of testing and inspection services for both SMT and through-hole assemblies.

Visual inspection/scanning microscopes

AOI inspection

In-circuit test

Functional testing include automated test equipment and system

Burn-in tests

Low/High Temp Chamber Testing

X-ray inspection and repair

Salt fog tester

Drop Test

packing vibration

Conformal coating and potting

6. What are your PCB assembly standards?

IBE has obtained the following IPC electronics industry standards for PCB assembly

IPC-A-600G for PCB production

IPC-620 for practices and requirements for cables, wire, and harness assembly manufacturing

IPC-A-610E PCBA Acceptability of Electronic Assemblies

7.Can you ship to my contract manufacturer for the final build?

Yes, we can ship your assemblies for final production. We can also offer turnkey, box build, and labor-only services

8.Where do you manufacture your products?

We have production plant based in shenzhen,China; Fremont,US,Bac Ninh,Vietnam, where to produce it depends on customer.