FAQ: What Should You Know About IPC-A-610?

IPC A-610 is one of the most used electronics inspection standards in the industry. Many OEM teams rely on it to confirm that their contract manufacturer builds assemblies that are safe, clean, and consistent. Whether you design, review, or assemble PCBAs, understanding this standard removes guesswork and helps prevent quality issues before products reach the field.

Below are the most common questions people ask about IPC A-610 and its application to medical device manufacturing.

What is IPC A 610, and why does it matter?

IPC-A-610 is a widely used inspection standard for electronic assemblies. It outlines what good soldering should look like, how components should be mounted, and the expected level of cleanliness and artistry. It’s important because it provides both engineers and assembly teams with a single, consistent set of guidelines against which to measure quality 

Medical devices require tight tolerances and consistent assembly quality to support patient safety. IPC-A-610 helps contract manufacturers like Spartronics deliver work that meets regulatory and functional expectations.
 

Who uses IPC A 610 in medical device manufacturing?

Engineers, quality teams, technicians, and contract manufacturers use IPC-A-610 every day for PCBA inspection verification and final acceptance. This standard applies to assembled boards only and does not govern bare PCBs.

OEMs rely on it to set expectations. We use IPC-A-610 training to keep assembly practices aligned with FDA and ISO 13485 quality systems.

What are the IPC A 610 product classes?

There are three product classes defined in IPC-A-610.  Class 1 is for basic consumer devices. Class 2 is for general industrial products. Class 3 is for high-reliability electronics.
Many medical devices are placed in Class 3 because they must deliver reliable electrical performance, last for years, and avoid hidden failures. Class 3 requirements raise the standards for everything from solder joints and cleanliness to component alignment and lead trimming.

How does IPC A 610 affect solder joint criteria?

IPC A 610 defines the exact appearance and measurable features of acceptable solder joints. It describes wetting angles, fillet height, lead coverage, pad fill, and acceptable voiding.

In medical device manufacturing, issues such as poor solder flow or excessive voiding can cause intermittent failures. While IPC-A-610 is commonly used as a visual reference, the actual soldering requirements are defined by J-STD-001, which technicians follow to ensure processes meet stringent Class 3 reliability standards.
 

Does IPC-A-610 include training and certification?

Yes. IPC offers training for operators, specialists, trainers, and master trainers. With IPC-certified trainers on site, teams can train operators directly to IPC-A-610, ensuring certified staff can accurately spot defects, interpret diagrams, and fully understand Class 3 requirements for high-reliability assemblies.

We invest in IPC-A-610 certification because it boosts inspection accuracy and helps ensure that our quality processes are consistent across shifts and facilities. Many OEMs request or require IPC-certified teams.
 

How does IPC-A-610 connect to ISO 13485 and FDA expectations?

IPC A 610 supports ISO 13485 and FDA design and process control requirements. It gives documented acceptance criteria that can be inserted into quality plans and inspection procedures.
Medical device manufacturers often reference IPC A-610 criteria in device history records and process validation documents. This creates traceability and consistent artistry from prototype to production.

What defects does IPC A-610 help identify?

It helps inspectors catch poor solder coverage, lifted pads, incorrect polarity, misalignment, solder bridging, contamination, and conductor damage. These defects often cause field failures that are hard to diagnose.
Using the standard reduces rework, improves reliability, and ensures that assemblies can withstand vibration, shock, and thermal cycling in clinical environments.

How do contract manufacturers apply IPC-A-610 on the production floor?

We follow IPC-A-610 as the standard for acceptability of electronic assemblies, applying it at defined inspection and verification points. IPC-A-610–trained operators are positioned at inspection steps, among soldering operators who are also J-STD-001 certified, and with test technicians during the tabletop/test process. Our work instructions include IPC images to help technicians clearly see and evaluate acceptable artistry during first-article reviews, reflow verification, and final inspection.

At Spartronics, we pair IPC-A-610 with automated optical inspection, technician cross-training, and ongoing improvement efforts to maintain consistent build quality across all product lines.
 

Does IPC-A-610 address cleanliness and contamination?

Yes. It provides criteria for acceptable levels of flux residue, foreign particles, and surface debris. Cleanliness is critical for medical electronics because contamination can create leakage paths or interfere with sensor performance.

Following IPC-A-610 helps verify that assemblies are clean enough for sterilization, packaging, or long-term clinical use.

IPC A 610 is one of the most essential standards for anyone building or reviewing medical electronic assemblies. It reduces risk, builds trust, and provides a shared understanding of what high-reliability manufacturing should look like. When your contract manufacturer follows IPC-A-610 and holds strong quality certifications, you can be confident that your products will perform as designed and comply with regulations.

If you want support from a contract manufacturing partner that meets IPC-A-610 standards and understands the demands of medical device production, contact Spartronics to discuss your project needs.