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What Regulations and Standards Apply to Medical PCB Assembly?

 Oct 20, 2020

Medical PCB Assembly

Printed circuit boards (PCBs) have become important across industries because of their use in electronic devices, and the medical industry is no exception. With continuous development in the tech world, today, more and more medical research and treatment methods have become computerized. This means PCBs for medical devices are becoming a standard requirement throughout this industry. As medical devices are essential to diagnose and treat illnesses and improve a patient’s health, setting strict standards for accuracy and patients’ safety is imperative. To create desirable outcomes and prevent device recalls, OEMs must follow strictest and demanding PCB assembly guidelines. These design standards control how the PCBs are made, documented, tracked, tested, and inspected. Would you like to know what standards and regulations are required for a medical PCB assembly? This post explains the same.

An Overview of Medical PCB Assembly Standards and Regulations

Medical devices are varied and used in different areas such as diagnosis, less or non-invasive procedures, 24-hour patient monitoring, remote monitoring, clinical research, and more. Thus, all biomedical devices demand specific standards and regulations. Here are some standards and regulations every PCB manufacturer should be aware of. So, let's have a look at them.

  • IPC: Formerly called the Institute for Printed Circuits (hence acronym IPC), it is presently called the Association Connecting Electronics. It is an international industry association responsible for publishing a series of standards for circuit boards. Some important standards are as follows:
    • IPC-A-600: This standard covers the acceptability of the circuit boards.
    • IPC-A-6012: It covers the qualification as well as performance specifications for PCBs.
    • IPC-A-610: It also covers the acceptability of electronic assemblies. There are different IPC standards for wire harnesses, soldering, enclosures, and cables.
  • ISO 9000: ISO stands for the International Organization for Standardization. It publishes several standards with the 9000 series that covers reliability and quality requirement of circuit board design, manufacturing, and testing. OEMs should be certified in one of the ISO 9000 standards for basic safety and essential performance of medical equipment.
  • FDA: The U.S. Food and Drug Administration introduces 21CFR820, which is a quality system regulation. The standard requires that the medical device OEM should carry out their manufacturing and quality control processes when they are not verified by subsequent test or inspections. If OEMs have the relevant accreditations and certifications, then regulatory bodies confirm that the product meets certain requirements. This streamlines the whole qualification process and helps reduce the time to market for the product.

These pointers are the common standards that OEMs work and comply with.

ISO 13485: Quality Management System When Building Medical PCBs

ISO 13485 is an important standard for the circuit board manufacturer as it decides the quality management system for devices in the medical industry. This standard is aligned with the ISO 9000 series for specifying in-depth quality and reliability requirement for medical products. ISO 13485 defines the specific criteria for the board manufacturer to put a documentation process for tracking all materials and components used in circuit board manufacturing. This is essential for medical equipment where manufacturers understand the recall process for material and components. Have a look at important highlights of ISO 13485:

  • Risk management and design control
  • Process Analysis
  • Promotion and awareness of other regulations
  • Documented quality control processes

Not all the standards require OEMs to be certified to develop medical products. But, these standards and regulations demonstrate to clients that the manufacturer has invested in the necessary systems and is fully focused on PCB assembly guidelines to satisfy all the requirements. All the above-mentioned information will help you understand the importance of standards and regulations in PCB assemblies for medical devices. If you are looking for PCBs to build your next medical equipment, then it is important to source them from an ITAR certified manufacturer like Accelerated Assemblies. The company provides PCB assemblies for the medical industry.