Medical device aluminum die casting covers the structural and enclosure parts of medical equipment: diagnostic instrument enclosures, imaging and gantry frames, analyser and infusion pump chassis, and surgical light arm housings. CharMax Precision casts these in A360 and A380 with full lot traceability, documented first article inspection, and coating systems chosen to survive repeated hospital disinfectant wipe-down.
Medical device aluminum die casting covers the structural and enclosure parts of medical equipment: diagnostic instrument enclosures, imaging and gantry frames, analyser and infusion pump chassis, and surgical light arm housings. CharMax Precision casts these in A360 and A380 with full lot traceability, documented first article inspection, and coating systems chosen to survive repeated hospital disinfectant wipe-down.
What separates medical work from the rest of our order book is not tighter tolerances — the dimensions are often looser than an automotive print — but the requirement that nothing changes without notice. A device manufacturer has validated the part as it was supplied, so an alloy source substitution, a die weld repair or a switch of coating supplier is a regulatory event for them even when it is routine for us. Our job is to hold the process still and document it.
We are ISO 9001:2015 certified. We are not ISO 13485 certified, so our medical work is limited to non-implantable equipment enclosures and structural components, and we are not a supplier of implantable devices or patient-contact critical components. Design ownership, risk management, biocompatibility and regulatory submissions remain with you as the device manufacturer; we supply the manufacturing evidence that supports them.
| Typical alloys | A360 for corrosion resistance and pressure tightness, A380 for machined structure |
|---|---|
| Typical part weight | 200 g to 9 kg per casting |
| Machine range | 160 to 1,250 tons cold chamber |
| Typical annual volume | 500 to 10,000 parts per device model |
| Typical wall thickness | 2.5 to 3.5 mm, 1.5 mm minimum on covers |
| Cleanable geometry | Internal radii of 2 mm or more, no blind crevices, deburred edges |
| As-cast tolerance | ±0.1 mm for the first 25 mm |
| Machined tolerance | ±0.02 mm on bores, sealing faces and mounting datums |
| Standard finish | Textured polyester powder coat over chromate conversion, grounding points masked |
| Traceability | Ingot certificate through shot lot, machining lot and finishing batch to packing list |
| Documentation | Documented FAI, material certificates, coating thickness and adhesion records, advance change notification |
| Certification | ISO 9001:2015 — not ISO 13485, non-implantable equipment parts only |
Medical enquiries usually come from a device manufacturer who needs an enclosure or structural part made to a frozen drawing, in modest volume, for a very long time, with evidence attached. The engineering is rarely the hard part.
A device might sell 1,500 units a year for ten years, then need spare enclosures for another seven. That combination is awkward: annual volume barely justifies tooling, but the tooling has to be stored, maintained and requalified across a span longer than most consumer products exist.
The device has been validated with the part as supplied. A different ingot supplier, a die insert repaired by welding, a new coating vendor or a change of masking method can all be regulatory events for the manufacturer. Suppliers who make silent improvements cause far more trouble in medical than suppliers who make none.
Enclosures are wiped down between patients with 70% isopropyl alcohol, quaternary ammonium, accelerated hydrogen peroxide or hypochlorite wipes. Coatings that look fine on an industrial housing chalk, soften, discolour or lift at the edges after a year of that, and the failure appears in the field rather than at incoming inspection.
Sharp internal corners, narrow gaps between features, blind pockets and unradiused seams collect fluid and biological soil and cannot be reliably wiped. Cleanability is a geometric requirement that has to be reviewed at the same time as castability.
A metal enclosure on a mains-powered device is part of the protective earth system, so designated grounding points must stay bare and conductive through the coating process. The same enclosure often provides the EMI shielding for sensitive analogue front ends, which depends on continuity across seams.
When a field complaint arrives, the manufacturer needs to know which lot a part came from, what alloy it was cast in, when it was made and what else shipped alongside it. Traceability has to be recorded at the time, because it cannot be reconstructed three years later.
Aluminum casting fits medical equipment for reasons that have little to do with cost. A cast enclosure is stiff, dimensionally stable, conductive for earthing and shielding, and it can be shaped with the generous radii and closed seams that make a surface cleanable — none of which a sheet metal fabrication or a plastic moulding delivers together.
Mass and stiffness matter on mobile equipment. Carts, portable analysers and imaging arms need a rigid frame that does not add weight a nurse has to push, and cast aluminum at 2.7 g/cm³ with a ribbed section provides that. On imaging and optical assemblies, stiffness also protects alignment: a frame that flexes when the equipment is moved changes the geometry the device was calibrated against.
Part consolidation reduces the number of joints, and every joint removed is a crevice removed. A single casting replacing a five-piece riveted or welded frame eliminates the seams that collect soil, the fasteners that loosen, and the tolerance stack that made the covers fit inconsistently.
The parts below represent the medical work we take: equipment-level enclosures and structural components, not devices or components in patient contact.
| Component | Alloy | Key requirement | Typical finish |
|---|---|---|---|
| Diagnostic instrument enclosure | A360 | Cleanable surfaces, EMI shielding, earth continuity at designated points | Textured polyester powder coat over chromate, grounding pads masked |
| Analyser chassis and internal frame | A380 | Rigid mounting datums for fluidic and optical modules, machined interfaces | Chromate conversion, machined datums bare |
| Imaging equipment frame and gantry cover | A380 | Stiffness to hold alignment, flatness across mounting planes, low mass | Powder coat, machined mounting planes |
| Patient monitor housing | ADC12 | Thin wall, wipe-down surface, cosmetic front face, shielded cavity | Textured powder coat to a signed colour master |
| Infusion and syringe pump chassis | A380 | Dimensional stability of the drive mechanism mounting, cleanable exterior | Powder coat, machined mechanism datums |
| Surgical light arm housing and joint | A360 | Stiffness and damping in a cantilevered arm, machined joint bores | Smooth white powder coat, bores machined bare |
| Dental and laboratory equipment housing | A360 | Chemical resistance to disinfectants, sealed against fluid ingress | Powder coat over chromate, cast gasket channel |
| Centrifuge and rotor housing | A380 | Containment stiffness, balanced geometry, machined bearing bore | Powder coat, machined bore and lid seat |
| Mobile cart structural bracket | A380 | Load capacity at bolted joints, machined datums, cleanable profile | Powder coat with radiused edges |
We do not quote implantable components, surgical instruments in patient contact, sterile-packaged parts or any part requiring an ISO 13485 certified manufacturer.
A360 has low copper content, which gives noticeably better corrosion resistance and pressure tightness than A380. That matters on exposed enclosures that get wiped with chloride-bearing disinfectants and on housings that must stay sealed. A380 remains the choice for internal chassis and frames that are heavily machined, because its machinability is the best of the common die casting alloys.
We ask for internal radii of 2 mm or more on any surface that has to be wiped, which is well above the casting minimum. Larger radii also carry coating better: paint and powder thin out at sharp corners, and a thin corner is where a coating first fails under repeated chemical exposure. Draft of 1 to 2° externally and 2 to 3° internally is unchanged from any other casting.
Blind pockets, narrow slots between bosses, unradiused seams and unsupported overlaps trap fluid and cannot be verified clean. Where a joint is unavoidable it is designed with a defined gap or a cast gasket channel rather than a nominal metal-to-metal fit. Every edge a hand or a wipe cloth touches is deburred, both for cleanability and so the operator does not catch a finger on a casting flash line.
Protective earth continuity is measured on the finished device, so designated grounding points must remain bare metal or be machined clean after coating. We ask for those points to be marked on the drawing with the masking requirement stated, because a fully coated enclosure is an insulator and rework by scraping paint is neither repeatable nor acceptable.
Most medical enclosure dimensions are comfortable at as-cast ±0.1 mm. The features that matter are where a fluidic manifold, optical bench, drive mechanism or bearing mounts, and those are machined to ±0.02 mm from cast datums. Identifying that small set early keeps machining cost proportionate on a low-volume programme.
A die survives 80,000 to 150,000 shots, so a 1,500-unit-a-year device will never wear its tooling out. The risk is not wear but neglect: tooling is stored on site, inspected on a schedule, and any repair is documented and notified in advance, with first article inspection repeated before the next lot ships.
The coating is the part of a medical enclosure most likely to fail in service, and it fails chemically rather than mechanically. Our default system is a textured polyester powder coat at 60 to 100 µm over a chromate conversion pretreatment, because the pretreatment gives adhesion and corrosion protection while the polyester topcoat resists alcohols and peroxides better than the epoxy systems commonly used on industrial housings.
Where the disinfectant list includes hypochlorite or a high-concentration peroxide, we recommend running coated test panels through your actual wipe protocol before production release rather than relying on a data sheet. Chemical compatibility depends on concentration, contact time and frequency, and only your cleaning instructions define those. Final validation of the finish for its intended use sits with you as the device manufacturer.
| Finish system | Typical thickness | Suited to | Limits to be aware of |
|---|---|---|---|
| Textured polyester powder coat over chromate conversion | 60 to 100 µm | Exposed enclosures, covers and carts that are wiped down daily | Adds thickness to fits and must be masked at grounding points |
| Smooth powder coat over chromate conversion | 60 to 100 µm | Cosmetic front surfaces and light-coloured equipment housings | Shows handling marks and any as-cast surface variation more than a texture |
| Wet paint | 25 to 40 µm | Colour-matched parts, thin films where a fit cannot absorb powder thickness | Lower chemical and abrasion resistance than powder coat |
| Chromate conversion only | Under 1 µm | Internal chassis and frames, and surfaces needing conductivity | Cosmetic appearance is functional at best, limited standalone protection |
| Shot blast only | None | Internal structural parts hidden inside the equipment | Bare aluminum will mark and oxidise in service |
| Mechanical polishing before coating | Preparation step | Cosmetic surfaces where a smooth coated appearance is required | Adds cost per part and does not replace the coating |
| Anodizing | 10 to 25 µm | Rarely specified on cast medical parts | High silicon content gives a dark, mottled film that will not match wrought parts |
Coating thickness is treated as a dimension on any fit, gasket land or grounding point. We measure thickness, gloss, colour and cross-hatch adhesion to ASTM D3359 per finishing batch and keep the records with the lot.
A medical customer is buying evidence as much as parts. The package below is what we build during a launch and maintain for the life of the programme; it is compiled as the work happens rather than reconstructed at shipment.
Being precise about scope prevents a failed audit and a wasted tooling investment, so this is stated plainly rather than buried in a capability list.
We manufacture non-implantable medical equipment enclosures and structural components: instrument housings, chassis, frames, covers, arms, brackets and equipment-level assemblies. We hold ISO 9001:2015 certification, supply documented FAI and lot traceability, and operate change control on anything that could affect your validated part. Device design ownership, risk management, biocompatibility assessment, sterilisation validation and regulatory submissions remain yours.
Die casting pays for itself above roughly 1,000 parts per year. Below that, or while you are still validating a design, CNC machining from billet is usually the faster and cheaper route. CharMax Precision runs a dedicated aluminum CNC machining operation for exactly that work, so you can prototype machined, then move to casting when volume justifies tooling.
No. CharMax Precision is certified to ISO 9001:2015 only, and we do not claim ISO 13485 status. Our medical work is limited to non-implantable equipment enclosures and structural components — instrument housings, chassis, frames, covers and brackets — manufactured with documented first article inspection, full lot traceability and advance change notification. We are not a supplier of implantable devices, patient-contact critical components or sterile-packaged parts, and design and regulatory ownership stays with you as the device manufacturer.
Yes, and it is recorded at the time rather than reconstructed. Each shipment traces back through the finishing batch, the machining lot, the casting shot lot and the ingot certificate, with the spectrometer verification for that ingot lot on file. That chain is what lets you answer a field complaint years later by identifying exactly which parts shared a lot with the one that failed, and it is demonstrated live during supplier qualification audits.
Our default is a textured polyester powder coat at 60 to 100 µm over a chromate conversion pretreatment, which handles 70% isopropyl alcohol and quaternary ammonium wipes well and resists accelerated hydrogen peroxide better than the epoxy systems used on industrial housings. Because compatibility depends on concentration, contact time and wipe frequency, we supply coated test panels for you to run through your own cleaning protocol before production release. Validating the finish for its intended use remains your responsibility as the device manufacturer.
We advise against it. High pressure die castings contain some entrapped gas by nature of the process, and repeated exposure to saturated steam at 121 to 134 °C can cause surface blistering, coating lift and staining. The medical parts we make are designed for wipe-down disinfection, not steam sterilisation. Where a component genuinely has to be autoclaved, machined wrought aluminum or stainless steel is the appropriate material and process, and we will say so rather than quote a casting that will disappoint in service.
By notifying you before anything happens, not afterwards. We will not change alloy source, coating supplier, masking method, machining route or process sequence without written notice, and a die repair or insert replacement triggers a repeat first article inspection before the next lot ships. Drawing revisions are controlled, superseded revisions are withdrawn from the floor, and the current revision is recorded against every lot so you can tie a shipment to a specific design state.
Yes, remotely or on site at our facility in Dongguan. A typical audit covers the ISO 9001:2015 certificate and scope, process flow and control plan for your part, calibration records for the CMM and gauges used, incoming material verification, a live traceability exercise on a finished lot, non-conformance and corrective action records, and the change control procedure. We will tell you in advance which requirements we do not meet so the audit confirms scope rather than discovering it.
We sign your NDA before receiving files and can sign a mutual agreement if you prefer. Your tooling is dedicated to your part and is never used for another customer, your drawings are not shared outside the engineering and production team assigned to your program, and we do not display customer parts or names in marketing material without written permission.
Send your 2D drawing and 3D model, the annual volume, your disinfectant list and the documentation your quality system requires. You will get piece pricing, tooling cost, a finishing recommendation and written confirmation of exactly which quality records we supply and which certifications we do not hold.