Medical Instruments
Yingstar is the premier manufacturer of medical PCBAs and medical PCB assemblies. Since medical electronics are associated with human health, strict safety and dependability standards must be met. For instance, the majority of PCBA manufacturers can provide primary certifications like ISO9001 and ISO14001. However, this is insufficient for a company like Yingstar, which can manufacture medical PCBAs and provides medical PCB Assembly services. We must adhere to medical industry standards, including ISO 13485 accreditation. In addition, certain implantable medical electronics necessitate greater precision and stability, so they must be designed to withstand severe medical environments, undergo more testing during production, and have their soldering quality monitored during assembly, etc.
Since the COVID-19 pandemic began, the global demand for medical electronics is continuously increasing. Yingstar has received numerous inquiries from the medical industry in this context. We produce a variety of medical PCBA devices, including CT scanners, surgical lighting, and several other products. Here are some examples of the medical PCB Assembly for medical products that we can supply to our clients:
Pacemakers
Respirators
Nursing monitor
Electric wheelchair
Digital nutrition pumps
MRI equipment
Patient locator
Cochlear implants
Ventilators
X-Rays
Surgical Machines
Electronic Implants
Defibrillators and Pumps
Monitoring and Diagnostic Equipment
Laboratory Equipment
Scanning technology
Control Systems
Insulin pumps
Medical PCB Assembly (Medical PCBA) Standard
Medical device development involves thorough risk assessment. These criteria are tested using several methods. Yingstar follows these key standards:
ISO 9000 or 9001: Addresses electronic product design, manufacturing, and testing quality and dependability.
ISO 13485: This QMS is for medical device makers. It regulates product design, development, manufacture, and post-market surveillance.
IEC 60601: International standards for medical electrical equipment safety and efficacy. Electric shock, radiation, and mechanical dangers are prioritized.
IEC 61010-1: Electric measuring, controlling, and lab equipment safety.
Electronic assemblies, including PCBs, must meet IPC-A-610. It covers soldering, hygiene, and other PCB fabrication standards.
FDA 21 CFR Part 820: This FDA rule specifies QMS requirements for medical device makers. Design, manufacture, and device labeling are covered.
UL 94: This standard governs PCB flammability. It specifies flame and ignition resistance.
CFR 820: Production and quality assurance.
Focus of Medical PCB Assembly
Medical PCB Assembly applications in the lab or operation room must be reliable. Medical equipment cannot fail. Thus, medical device circuit boards require the following PCB assembly practices:
- The medical device’s component count, the board size, and thermal management need careful consideration when doing PCB design.
- A successful board requires precise component placement and trace routing.
- Reliable medical PCB assembly devices require component selection. The best medical PCBA device components are trustworthy, sturdy, and long-lasting.
- Choose an established medical PCB assembly facility or medical PCBA fabricator. Ensure high-quality circuit board production.
- Lead-free medical PCB assembly is efficient, and a sustainable company can boost your project.
- Medical PCBAs need high cleaning. In medical equipment, residual cleaning agents may harm patients. Cleaning prevents short circuits caused by surface stains.
- To ensure dependability, performance, and safety, assembled circuit boards must be inspected and tested.
- Engineers should consult EMI guidelines to avoid EMI on the medical PCBAs.
To ensure that the medical PCB assembly will meet or exceed manufacturing requirements and customer satisfaction demands, we provide comprehensive documentation with traceability to all of our medical customers and have a deep appreciation for the sensitive nature of the medical field.
Contact Yingstar today and find out why thousands of engineers rely on us for their medical PCB assembly projects.
