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MEDICALDEVICEMACHINING
Reference hub

Materials for Medical Device and Equipment Components

Capability windows are confirmed per drawing ยท Medical Device Machining editorial team

Non-implant medical devices use a short list of metals and engineering plastics again and again. The choice is driven by four questions: what the part touches (patient, drug, reagent or nothing), how it is cleaned and sterilized and how often, what it must do mechanically, and what the program can afford. This hub sorts the common materials by those questions and links to the detail pages. Grade designations for implant alloys are on the separate materials page.

Material Typical device families Steam Gamma Machining Cost tier (1 low to 4 high)
6061 aluminium, anodized Housings, trays, frames, fixtures Yes, dyes may fade Yes Easy 1
303 / 304 stainless Equipment shafts, brackets, fittings Yes Yes Easy (303), moderate (304) 2
316L stainless Fluid parts, instrument parts, trays Yes Yes Moderate 2
17-4 PH stainless Instrument parts needing hardness Yes Yes Moderate, heat treat route 2
Titanium Grade 2 / Grade 5 Lightweight instruments, MR-zone parts Yes Yes Slow, heat at the tool 4
Acetal (POM) copolymer Nuts, gears, clips, fixtures Limited cycles No Easy 1
Polycarbonate Clear housings, windows, manifolds Under 100 cycles in resin data Discolours Easy, stress-sensitive 2
PMMA (acrylic) Clear manifolds, light guides No Yellows Easy, crazes with solvents 1
PSU Clear parts needing some steam Several hundred cycles Yes, amber tint Moderate 3
PPSU Reusable handles, sterilization case parts Over 1,000 cycles in resin data Yes Moderate, anneal 3
PEI Housings, connectors, instrument parts Yes, check grade data Check grade data Moderate 3
PEEK Instrument parts, valves, fluid fittings Over 1,000 cycles in resin data Yes Moderate, anneal 4
PTFE Seals, seats, liners Yes No Easy, creeps 2
PVDF Fluid parts Yes Yes Easy 2

Sterilization columns summarize the sterilization compatibility chart, which cites the source for each rating. Cost tiers are typical relative values, not quotes.

How the detail pages fit together

Page Answers
Material compatibility with sterilization methods Which of 20 materials survive steam, EO, gamma, e-beam and hydrogen peroxide, and how to read cycle counts
USP Class VI plastics What the Class VI statement tests, how it compares with ISO 10993 and how to check a certificate
Tolerance windows by process How material choice widens or narrows the practical tolerance

More grade and polymer pages are planned for aluminium housings, stainless for equipment, PPSU, PEI, acetal and clear plastics. Until they are live, the blog covers aluminium housings and anodizing and PEEK versus PPSU for instrument handles.

Choosing in four steps

  1. Contact and duration. Parts in the patient or drug path narrow the list to grades with medical statements and a biological evaluation plan. Equipment parts that touch nothing open it to commercial grades with mill certificates.
  2. Reprocessing. Name the cleaning agents, the sterilization method and the cycles expected over the product life. This removes more candidates than any mechanical property.
  3. Function. Stiffness, wear, transparency, conductivity, magnetic behaviour and weight.
  4. Cost and supply. Availability of the size and grade, the machining time and the finish.

The device maker makes the decision and owns its biological evaluation. The partner shops in southern Vietnam machine the grade on the drawing and keep its certificate with the lot. Send your drawing through the RFQ form and we reply within 24 business hours.

Sources

Standards and rules are cited as references. They are not claims about medicaldevicemachining.com or any shop. Confirm the edition and current status with the issuing body.

Frequently asked questions

Which materials does this guide cover?

Materials for non-implant devices and equipment: housings, instruments, drug delivery and diagnostic parts, trays and fixtures. Implant alloys and their ASTM F specifications are listed only for orientation on the materials page; implant material selection is outside this guide.

Who chooses the material for a medical part?

The device maker, as part of design controls, risk management and the biological evaluation of the device. The shop machines the grade named on the drawing, keeps its certificate with the lot and can flag machining or sterilization issues during DFM review.

What does cost tier mean in the matrix?

A rough relative ranking of material cost per kilogram and machining time, from 1 (lowest, for example aluminium and acetal) to 4 (highest, for example PEEK and titanium alloys). Actual cost depends on form, size, quantity and market prices.

Have a drawing for this kind of part?

Upload STEP, PDF or DWG. Mutual NDA before review on request. We reply with matched shop options, itemized pricing, lead time and DFM notes.

First response within 24 business hours. No phone calls, everything in writing.