4 Ways We Prove Your Device Won’t Fuel a Fire

A device that passes every electrical safety check can still be a fire hazard the moment something inside it overheats.

Flammability Testing for medical device housings, connectors, and internal components answers a question electrical safety testing alone doesn’t cover: if a fault does generate enough heat to ignite something, does the device stop the fire from spreading, or does it become the fuel. Our Flammability Testing for medical device service at the Oragadam laboratory covers four checkpoints across ignition sources, material self-extinguishing behaviour, and oxygen concentration thresholds, referenced to UL 94 for plastics classification, IEC 60695 for fire-hazard testing, and ASTM D2863 for oxygen index.

This checkpoint simulates the kind of overheating a poorly-rated resistor, an overloaded connector, or a failing solder joint can generate inside a device enclosure. A heated wire loop is pressed against the material at a specified temperature, and the material either self-extinguishes within a defined time or it doesn’t — there’s no partial pass. This checkpoint is run twice across most enclosure designs: once against the material specification a manufacturer submits, and once as a confirmation check on the actual moulded part, because processing conditions can shift a material’s flammability behaviour away from the raw resin’s rated performance.

This checkpoint goes further than the glow-wire checkpoint by applying an open flame directly to a sample under controlled conditions and classifying the material against UL 94 categories such as V-0, V-1, and V-2 based on burn time, dripping behaviour, and whether flaming particles ignite material below it. This checkpoint is the one most manufacturers already know by name because it’s the one referenced most often in a bill-of-materials flammability declaration, and it’s also the checkpoint we see most requests for repeat testing on when a resin grade or colourant changes mid-production.

Ignition resistance of medical-device enclosures testing evaluates the complete assembled housing rather than a flat material coupon, because a moulded enclosure with ribs, vents, and wall-thickness transitions doesn’t always behave the way a flat test plaque predicts. Limited oxygen index testing for medical device polymers determines the minimum oxygen concentration required to sustain combustion of the material, giving a single comparable number across different formulations and a useful early screening tool before a full UL 94 study is commissioned. Manufacturers bring their programs to Kiyo R&D Lab because a single missed checkpoint in Medical Device Testing doesn’t show up as a lab finding — it shows up as a fire that spread further than the enclosure design assumed it would. Running glow-wire, plastic flammability, enclosure-level ignition resistance, and oxygen index checks under one accredited scope at Oragadam, with reports formatted for direct regulatory submission, is what turns a Flammability Testing for medical device study from a paperwork line item into evidence your quality team can actually stand behind.

Kiyo R&D Lab – Oragadam

Our flammability testing suite is based at No.13, Srinivasa Perumal Street, Panapakkam, Serapanacheri, Greater Chennai, Tamil Nadu 601301.

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