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Medical · Electronics Sealing, Thermal & EMI · How to Spec

How to Spec a Medical-Electronics Sealing, Thermal, or EMI Part: What to Send H-O for a Quote

Thermal-interface stack cross-section (medical-device electronics) A die-cut thermal interface material fills the air gap between a heat-generating component on a PCB and the heat-spreader enclosure wall so heat conducts across the joint. An adjacent die-cut dielectric barrier holds off voltage between the board and the metal chassis, and a conductive EMI/ESD gasket closes the enclosure seam to the frame and gives static charge a path to drain. MEDICAL-DEVICE ELECTRONICS · THERMAL INTERFACE Thermal-interface stack — heat across the gap, voltage held off, seam closed A die-cut TIM (thermal interface material) carries heat from a hot component across an air gap to the enclosure wall; a dielectric barrier and an EMI/ESD (electrostatic discharge) contact sit alongside on the same package. HEAT SPREADER / ENCLOSURE WALL Die-cut TIM gap filler Heat-generating component PCB ▲▲▲ heat flow Fills the microscopic air gap; conforms at low pressure GROUNDED CHASSIS Board / busbar Die-cut dielectric barrier holds off voltage EMI / ESD shield-to-frame contact (enclosure seam) Shielded lid Conductive EMI/ESD gasket Metal frame ▲▲▲ charge drains to frame closes seam to RF Die-cut converted part (H-O) Component / conductor Spreader / frame / lid Dielectric barrier Heat flow Representative — validate in the application.

The fastest medical-electronics quote starts with which job each part does, not the material. If you tell H-O whether the part seals, conducts heat, insulates, or shields, then send the closure force, the gap and clamp, the working voltage, or the seam geometry, engineering can recommend families and grades and quote die-cut parts in one pass. This is the checklist that turns a controller-board idea into converted parts without a round of back-and-forth.

Technician inspecting medical electronic device

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Start with the job, because the four are different

The single most useful thing on a medical-electronics RFQ is naming which of four jobs each part does: seal the enclosure, conduct heat, insulate a voltage, or shield a seam. The four need different properties, so naming the job narrows each part to a seal, a thermal interface, a dielectric, or an EMI gasket, and it avoids conflating them, for example asking a conductive thermal interface to sit where it could short, or a seal to act as a shield. Name the job for each part; the family follows.

The inputs that size each job

Once each job is named, each has its own short list:

  • Thermal interface. The gap, the stack tolerance, the clamp or mounting pressure, the heat load, the thermal cycling, and whether the path must insulate, so we choose boron-nitride or graphite and size it to stay in its compression range.
  • Dielectric. The working voltage, any creepage and clearance, and the barrier geometry, so we size a polyimide thickness with margin per ASTM D149.
  • Enclosure seal. The closure force, the lid stiffness, the gland geometry, and the wipe-down and sterilization route, so we choose closed-cell or solid medical silicone.
  • EMI gasket. The seam geometry, the closure force, the mating-surface finish, and how the clamp is retained, so we choose a conductive form and flag the grounding contact.
  • Patient-facing and quantities. Which parts are patient-facing, the biocompatibility basis per the ISO 10993 series if so, and prototype plus production volumes.

What format to send

A dimensioned drawing or a DXF or STEP of each part outline is ideal, but a sketch with the key dimensions and the job labeled is enough to start, and a board layout showing where each part sits helps us see the gap, the seam, and the grounding context. If you have materials in mind from the parent page, name them and we confirm them against the duty; if not, describe each job and let engineering recommend families.

Tell us which parts ship kiss-cut on a liner for placement and whether they should be kitted together.

Reference Table · What to Send

From Controller-Board Idea to Converted Parts

Why this list: each input maps to a decision engineering would otherwise have to ask about. Sending all of them lets us recommend families and quote die-cut samples in one pass instead of a round of back-and-forth.
You sendIt decides
Which job per partSeal vs thermal vs dielectric vs EMI
Gap + tolerance + clamp + heat loadBoron-nitride vs graphite, pad size and range
Working voltage + creepage/clearancePolyimide thickness with margin per ASTM D149
Closure force + gland + sterilizationClosed-cell or solid medical silicone seal
Seam geometry + contact-surface finishConductive form + grounding-contact flag
Patient-facing + quantitiesISO 10993 basis and tooling approach

Thermal behavior per the maker data; dielectric strength per ASTM D149; biocompatibility basis per the ISO 10993 series where patient-facing; thermal, emissions, and dielectric qualification are confirmed on the assembled product by the device builder.

A worked example

Say you send: a thermal interface from a power component to the chassis, gap stated with a tolerance, clamp load stated, heat load and thermal cycling described, the path crosses a live pad so it must insulate, internal-only so no biocompatibility basis needed, 200 prototype and 12,000 per year.

From that, engineering would point at a boron-nitride silicone thermal gap pad sized so the installed compression sits in its range across the gap tolerance, because the path must insulate over a live pad, and quote it kiss-cut on a liner. Where the gap were flat and well clamped and insulation were not required, the recommendation would shift toward a graphite thermal interface. That is the whole loop in one pass.

How H-O Products helps

H-O Products is a precision die-cut converter, not a raw-material producer and not the device maker. Tell us the job for each part and the duty and we recommend families and grades, then die-cut, kiss-cut, laminate, and kit the parts to your drawing, with material traceability and lot-code TDS records under our ISO 9001:2015 certified quality management system in Winsted, Connecticut.

Grade-level values are confirmed against the maker's current data, and where a part is patient-facing we cite the maker's published biocompatibility basis per the ISO 10993 series. Thermal, emissions, and dielectric qualification and device clearance stay with the device builder.

Frequently asked questions

What is the single most useful thing to put on a medical-electronics RFQ?

Which of four jobs each part does: seal the enclosure, conduct heat, insulate a voltage, or shield a seam. The four need different properties, so naming the job narrows each part to a seal, a thermal interface, a dielectric, or an EMI gasket and avoids conflating them. Once each job is named, the closure force, the gap and clamp, the working voltage, or the seam geometry sizes the specific part.

Do I have to send a CAD drawing, or is a sketch enough?

A sketch with the key dimensions and the job labeled is enough to start, and a board layout showing where each part sits helps us see the gap, the seam, and the grounding context. A dimensioned drawing is better, and a DXF or STEP of each part outline is best because it lets us cut a die-cut sample on your exact geometry fastest. Send whatever you have; engineering can begin from a clear sketch.

What do you need to size a thermal interface?

The gap, the stack tolerance, the clamp or mounting pressure, the heat load, the thermal cycling, and whether the path must insulate. Those choose between an insulating boron-nitride gap pad and a conductive graphite interface, and size the pad so the installed compression sits in its working range across the gap tolerance, which is what prevents marginal contact and pump-out. If the path crosses a live component, the insulating boron-nitride pad is the safe choice.

What do you need to size a dielectric barrier?

The working voltage, any creepage and clearance constraint, and the barrier geometry. With those, we size a polyimide thickness with margin against the dielectric strength on the maker TDS per ASTM D149, choosing a plain grade or a bondable FEP-coated grade if it laminates into a stack. Sizing to the working voltage with headroom, not the minimum, is what prevents a service breakdown.

What do you need to choose an enclosure seal?

The closure force, the lid stiffness, the gland geometry, and the wipe-down and sterilization route. Those choose between a medical cellular silicone (BISCO MS-80 / MS-96) for a wipe-down lid and a solid medical silicone for a toleranced groove, sized to seat across the worst-case unsupported span. The diagnostics enclosure blogs on the related page go deeper on enclosure sealing if that is the main part.

What do you need to choose an EMI gasket?

The seam geometry, the closure force, the mating-surface finish, and how the clamp is retained. The closure force and geometry choose between a conductive elastomer and a conductive foil, and the mating-surface finish tells us where to flag a bare-metal contact zone so the gasket can ground. We cut the conductive part; the grounding scheme and emissions qualification are the device builder's.

When does a medical-electronics part need a biocompatibility basis?

Only where it contacts a patient-facing surface; many internal thermal, dielectric, and EMI parts do not, but the device owner determines that. Where a basis is needed, we convert materials whose makers publish one per the ISO 10993 series and pass it through with traceability. Tell us which parts are patient-facing and which are internal, and we point you at materials whose makers publish the basis you need.

Can you kit the seal, thermal pad, dielectric, and EMI gasket together?

Yes. We die-cut each part to its own drawing, kiss-cut on a liner for placement, and kit them under one part number so the line receives a reconciled set rather than loose pieces, with the conductive and insulating parts kept clearly separated and with material traceability and lot-code TDS records. Tell us which parts to kit and we package them for your line.

How fast can I get samples once I send the spec?

For common die-cut configurations on materials we keep on hand, samples typically ship in 3 to 5 business days, and sending a DXF or STEP of each outline is the fastest path because we cut on your exact geometry. Standard production runs about two weeks after drawing approval, and expedited service is available. MOQ varies by material and part. A complete checklist on the first pass keeps the sample loop short.

Does H-O qualify the thermal, dielectric, or emissions performance?

No. H-O converts the sealing, thermal, dielectric, and EMI materials to your drawing and supplies material traceability and lot-code TDS records that support your file. Qualifying the thermal performance, verifying the dielectric, qualifying the emissions, performing any biocompatibility testing per the ISO 10993 series, and clearing the device belong to the device owner and its test houses. Our deliverable is the converted, die-cut parts.

What do I send to get a medical-electronics quote?

Name the job for each part, then send the gap, tolerance, clamp, heat load, and cycling for a thermal interface; the working voltage and barrier geometry for a dielectric; the closure force, gland, and sterilization route for a seal; the seam geometry and contact-surface finish for an EMI gasket. Add which parts are patient-facing, any biocompatibility basis needed, whether to kit them, and the quantities. With that, engineering recommends families and grades and quotes die-cut parts.

Send your medical-electronics spec for a quote

Name the job for each part, then send the gap and clamp, the working voltage, the closure force, or the seam geometry plus the quantities, and we will recommend families and grades and quote die-cut parts to your drawing.

Samples typically ship in 3 to 5 business days for common die-cut configurations on materials we keep on hand; standard production runs about two weeks after drawing approval; expedited service is available. MOQ varies by material and part.

Family-owned in Winsted, Connecticut since 1971 · ISO 9001:2015 certified · OEMs worldwide send us a drawing — and get back their part.

Related reading

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Name the job for each part and send the duty and geometry—engineering reviews every RFQ and converts samples on your geometry.

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Part & quantity
Typical response in one business day. Samples typically 3–5 business days; production in about 2 weeks.

Last updated · Reviewed by H-O Products engineering (ISO 9001:2015 certified converter, Winsted, CT).

References

  • ASTM D149 (dielectric breakdown voltage and dielectric strength of solid insulating materials), cited by designation for the polyimide dielectric basis.
  • ISO 10993 series (biological evaluation endpoints) and USP Class VI, cited by designation where a part contacts a patient-facing surface.
  • Manufacturer thermal data and technical data sheets for the boron-nitride and graphite thermal interfaces, polyimide film, medical silicone, and conductive EMI elastomer and foil grades named on the parent application page.

This article summarizes material-selection and design principles for medical-electronics sealing, thermal management, and EMI protection using the families and published test methods cited on the parent application page. Comparisons are qualitative; per-grade values are maker technical-data-sheet figures and must be confirmed on the manufacturer's current TDS at your installed condition. Standards (ISO 10993, USP Class VI, ISO 11607, IEC, ASTM, UL) are cited by designation for context, not as a claim of qualification or registration.

H-O Products is a precision die-cut converter, not a raw-material producer and not the device maker; biocompatibility testing, sterilization validation, device clearance, and final-assembly certification belong to the device owner and its test houses.

H-O Products Corp · Precision die-cut converting · Winsted, CT · ISO 9001:2015 certified organization