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Medical Device PCB Assemblies: Understanding Standards and Regulations

Mar 20, 2024

When it comes to medical equipment, the key requirement is to function as intended and accurately each and every time it is used. Any medical equipment that fails to function as expected will put a doctor into a tough situation and also jeopardize life of a patient using them. Therefore, medical equipment must be designed to comply with stringent and exacting standards regulating the medical sector. Having said this, the compliance extends to all components, including printed circuit board assemblies that are integral parts of these devices. This post gives an overview of the standards and regulations that apply to medical device PCB assembly design and manufacturing.

Standards and Regulations Governing Medical Device PCB Assembly Manufacturing

Numerous standards govern the design and manufacturing of medical device PCBs. Adherence to these standards would depend on the market segment the board is intended for. The following are some common standards and regulations governing medical device PCB assembly manufacturing.

• ISO: This is the acronym for the International Organization for Standardization which publishes quality standards related to PCB design and manufacturing.

  • ISO 9000: The ISO 9000 standard outlines precise standards for PCB design, production, and testing in terms of quality and dependability. Original equipment manufacturers (OEMs) must hold an ISO 9000 certification regarding the performance and safety of medical equipment.
  • ISO 13485: This industry standard is updated for medical technology devices and focuses on current trends. This standard guarantees that PCB assembly manufacturers adhere to strict quality control and documentation procedures.
• IEC 60601 - This set of standards addresses the functionality and safety of medical electrical equipment, including PCB-containing devices. Electromagnetic compatibility, electrical safety, and system functionality are all covered under the standard.
• IPC- (Industry for Printed Circuits): One of the most popular standards in the medical device manufacturing industry is IPC. Guidelines for the design, fabrication, and testing of printed circuit boards and electronic assemblies are published by the Industry for Printed Circuits - IPC. The following set of IPC standards is particularly pertinent to PCB manufactured for use in medical devices:
  • IPC-A-600:This specifies the circuit board’s acceptability.
  • IPC-A-610: This specifies the acceptability of electronic assemblies.
  • IPC-A-630: This specifies the acceptability standard for inspection, manufacturing, and testing of PCBs.
  • IPC 6012: This specifies the performance and qualification requirements for the PCBs.

FDA: The US Food and Drug Administration is responsible for managing and approving medical devices by monitoring their production, operation, and safety. The FDA has specified in 21CFR820 the standards for the manufacturing and quality system regulations for medical devices. When producing medical PCBs for the healthcare industry, OEMs and contract manufacturers adhere to certain common criteria. ISO has published a standard for quality management while creating medical PCB assemblies in order to concentrate on the dependability and quality of medical devices.

Factors you must consider while designing PCBs and assembling them in medical devices

When you are designing PCBs in medical devices, you must consider a few factors that can help you increase the lifespan of your devices. Take a look below at the factors that you can keep in mind while designing them:

• Consistency: The primary requirement of the medical device is to produce dependable results because its use has the potential to impact human life. Therefore, accuracy is crucial while creating a medical printed circuit board.
• Safety: A few medical gadgets are worn on the body or implanted as tiny circuits. One fundamental necessity of the medical PCB design is to safeguard the patient against any risks resulting from high temperatures or vibrations.
• Convenience: When building a medical PCB, user-friendliness is crucial. Here, the product's ease of use and robustness are important factors to take into account.
• Lifespan: To guarantee a long lifespan for the medical equipment, an efficient on-board battery or power design is required. Recognizing the repeated failure points can help in designing a robust product and improving the device’s timeline.

The industrial standards and regulations discussed in this post play a pivotal role in ensuring the quality, safety, and reliability of medical device PCB assemblies. Hence, it is always recommended to partner with a PCB assembly services provider who strictly adheres to these standards and regulations. If you are considering PCB assembly services for medical devices, then many names may emerge, but Accelerated Assemblies stands tall among them. For them, it is not just a regulatory requirement, but a fundamental aspect of their commitment to serving the healthcare industry and its patients with utmost safety and precision, maintaining the quality of tools. Contact their team today and discuss your medical device PCB assembly requirements.