Bioceramics (BIO)

Bioceramics (BIO) — Zirconia & Aluminum Nitride Components for Medical Device Manufacturers

ZrO₂ · AlN · Production grades ZOI60 / ANG34

Bioceramics, in the way LONGYI's customers use the term, means precision components machined from oxide and nitride advanced ceramics — chiefly zirconia (ZrO₂) and aluminum nitride (AlN) — for devices that contact the body, handle pharmaceuticals, or sit close to sensitive electronics. This is not a hypothetical product line: LONGYI has already shipped zirconia and AlN components across four distinct medical and dental applications, built entirely to each customer's own drawing, specification and incoming-inspection criteria. LONGYI is a precision ceramic machining OEM, not a certified medical device manufacturer — the sections below say plainly what that does and does not cover.

At a Glance

4Medical & Dental Applications Shipped
2Material Families — Zirconia & Aluminum Nitride
OEMBuild Method — To Your Drawing & Spec
Your QCOwns Biocompatibility & Sterilization Validation
The One Advantage

We already build this. Your quality system still decides if it's medical-grade.

LONGYI does not hold ISO 13485 certification and does not claim any grade is pre-validated to implant or device standard — that determination belongs to your quality system, not to us. What we can back up with real production history: LONGYI has manufactured zirconia components for a cardiovascular device connector, a dental cleaning equipment nozzle, and a pharmaceutical drug injection/mixing nozzle, and aluminum nitride components for a mechanism pin in a medical device — four separate applications, each built to the customer's own drawing and released against their own incoming inspection. The honest limit: neither ZOI60 nor ANG34 has been independently tested or certified against a specific ISO standard such as ISO 6474 or ISO 13356 — if your part needs that certificate, tell us which standard and we will scope the qualification work with you rather than assume it is already covered.

Materials We Manufacture for Medical & Dental Devices

Both are standard LONGYI production grades with full engineering property data published on their own material pages — this page does not repeat numbers that have not been validated for medical use.

Zirconia (ZrO₂) Production grade: ZOI60 (99% ZrO₂)

Our most-used bioceramic candidate, with three shipped applications behind it — a cardiovascular device connector, a dental cleaning equipment nozzle, and a pharmaceutical injection/mixing nozzle. Zirconia's fracture toughness and hardness suit both thin connector geometry and orifice/nozzle bores that see repeated fluid or particulate flow.

  • Chemically inert oxide ceramic, non-metallic and non-magnetic
  • Mirror-polishable finish achievable
  • Full industrial-grade property table on our Zirconia (ZrO₂) page
Aluminum Nitride (AlN) Production grade: ANG34 (99% AlN)

Shipped as a mechanism pin component in a medical device. Alongside the thermal and electrical-insulation properties AlN is best known for on our Aluminum Nitride page, this application drew on its hardness and dimensional stability for a precision mechanical part.

  • Non-metallic, non-magnetic, electrically insulating
  • Dimensionally stable under repeated actuation
  • Full industrial-grade property table on our Aluminum Nitride (AlN) page

High-purity alumina (AOI38, 99% Al₂O₃) is also in our standard range and is chemically similar to the alumina referenced in ISO 6474, but LONGYI does not yet have a shipped medical-device case for it — see our Alumina (Al₂O₃) page if that is the material your part needs. The exact composition and grain-size testing that ISO 6474 / ISO 13356 require for a medical-grade certificate have not been independently verified against any LONGYI grade — plan for that as a qualification step, not an assumption.

What This Means for Your Design

Chemically Inert
Zirconia and aluminum nitride are chemically stable ceramics — they do not corrode or release metal ions the way stainless steel or Co-Cr components can under long-term body-fluid or drug contact. That inertness is a property of the material itself, not a certification LONGYI is issuing.
Wear & Erosion Resistant
A metal nozzle orifice gradually erodes under repeated water, polishing-powder or drug-formulation flow and drifts out of its spray or dosing tolerance. A ceramic bore is harder and more erosion-resistant, which is the general reason this class of material is chosen for nozzle applications like a dental cleaning device or a drug mixing nozzle.
Withstands Sterilization
Zero water absorption and chemical stability mean these ceramics hold their dimension and surface finish through repeated autoclave or chemical sterilization cycles, which matters for a reusable device component such as an equipment nozzle.
Non-Magnetic & Insulating
Neither material is ferromagnetic or electrically conductive, so a ceramic component near or inside an electronic device housing does not add magnetic interaction or a short-circuit path — relevant to both a cardiovascular device connector and a mechanism pin sitting close to electronics.

These are general properties of zirconia and aluminum nitride ceramics relevant to this class of part. The specific design driver behind each customer's material choice is theirs; LONGYI is not restating their internal engineering rationale, only the material science that is publicly true of the ceramic itself.

Applications We've Shipped

Four real production applications, described in general terms — customer identity and drawings are confidential and are not shown here.

Zirconia

Cardiovascular Device Connector

A precision zirconia connector for a cardiovascular-related medical device, machined to the customer's drawing and released against their own incoming inspection.

Zirconia

Dental Cleaning Equipment Nozzle

A zirconia nozzle for a professional dental cleaning device — the kind of application where a metal orifice would gradually erode under repeated water and polishing-powder flow and drift out of spray tolerance.

Zirconia

Pharmaceutical Injection & Mixing Nozzle

A zirconia nozzle used in a drug injection / mixing application, where chemical inertness and a stable bore dimension matter for consistent dosing over repeated cycles.

Aluminum Nitride

Medical Device Mechanism Pin

An aluminum nitride pin used as a mechanism component in a medical device, where hardness, electrical insulation and dimensional stability suit a precision part that must hold tolerance under repeated actuation.

When Bioceramics Is the Wrong Choice

We would rather redirect you to the right material page than have you specify a candidate that does not fit.

NEEDS EXTREME HARDNESS

For a wear surface beyond what zirconia or AlN can take, silicon carbide (SiC) reaches 22–23 GPa Vickers hardness, though it is not typically specified for implant or body-fluid contact.

NEEDS HEAT DISSIPATION

AlN conducts heat far better than zirconia, but if the requirement is maximum thermal conductivity rather than a mechanism component, see the full Aluminum Nitride (AlN) page — 220 W/(m·K) at the ANG34 grade.

NEEDS ESD DISSIPATION

Zirconia and AlN are both strong electrical insulators — the opposite of what a static-sensitive handling fixture needs. For that, see anti-static ceramic (ATC).

NEEDS PROTOTYPE IN DAYS

Sintered zirconia or AlN parts take weeks — forming, sintering, then diamond grinding. For a design still in revision or a one-off needed fast, machinable ceramic is cut directly from stock with no sintering step.

NEEDS VACUUM PERMEABILITY

Both bioceramic candidates are fully dense with zero porosity. For a chuck or fixture that must pull vacuum across its working face, porous ceramic (PC) is built for that instead.

Parts We Make

Bioceramic components most often ship as custom connector, nozzle or mechanism geometry rather than as a catalogue part — the closest standard product lines are our ceramic connector and dispensing nozzle.

LONGYI has manufactured zirconia components for a cardiovascular device connector, a dental cleaning equipment nozzle and a pharmaceutical injection/mixing nozzle, and aluminum nitride components for a medical device mechanism pin. Customer identity and design details are confidential and are not shown here.

From Material to Finished Part

Choosing the material family is the easy half. Whether it can be produced — and validated — to your requirement depends on process control and documentation.

Manufacturing

Advanced Ceramics Manufacturing

Zirconia and AlN parts start as pressed or injection-moulded green bodies, sinter to near-final shape, and are then diamond-ground and lapped to reach final tolerance, flatness and surface finish — the same in-house process behind the four applications above.

See our manufacturing process
The Manufacturer

About LONGYI Precision Technology

We are a Taiwan-based advanced ceramic manufacturer, not a trading house. Forming, sintering, CNC and 5-axis machining, and final inspection are handled in-house, which is what makes build-to-drawing, build-to-sample work practical — including the material traceability documentation your qualification process will ask for.

About LONGYI Precision Technology

Evaluating Zirconia or Aluminum Nitride for a Medical Device Component?

Send your drawing, material specification and quality requirements — including any ISO standard or certificate the part must meet. We will tell you plainly what we can build in-house today, informed by four applications already in production, and what would need to be qualified together first.

Talk to Our Engineers

Frequently Asked Questions

Q1

What is Bioceramics (BIO)?

A

Bioceramics is LONGYI's term for precision components machined from zirconia (ZrO₂) and aluminum nitride (AlN) for devices that contact the body, handle pharmaceuticals, or sit close to sensitive electronics — used where a part must be chemically inert, non-magnetic and dimensionally stable.

Q2

Is "technical ceramics" the same as "advanced ceramics"?

A

Yes. Advanced ceramics, technical ceramics and fine ceramics are three regional names for the same family of engineered materials — North America and Taiwan typically say advanced ceramics, Europe says technical ceramics, and the term changes with the region, not the material.

Q3

Is LONGYI ISO 13485 certified, or are your bioceramic components FDA cleared?

A

No. LONGYI is a precision ceramic machining OEM, not a certified medical device manufacturer, and we do not hold ISO 13485 certification or any device-level regulatory clearance ourselves. Biocompatibility testing, sterilization validation and device-level regulatory approval remain your quality system's responsibility — we manufacture to your drawing, specification and incoming-inspection criteria, and provide the material and process documentation that supports your own qualification file.

Q4

What kinds of medical and dental device parts have you actually manufactured?

A

Four applications so far: a zirconia connector for a cardiovascular-related device, a zirconia nozzle for a dental cleaning device, a zirconia nozzle for a pharmaceutical injection/mixing application, and an aluminum nitride mechanism pin in a medical device. All four were built to the customer's own drawing; customer identity and design details are confidential.

Q5

What materials do you use, and where can I see the engineering data?

A

Our two production grades with medical-device history are ZOI60 (99% zirconia) and ANG34 (99% aluminum nitride). Full property data for each is on our Zirconia and Aluminum Nitride pages. Neither has separately been tested against a specific ISO medical-ceramic standard — tell us if your part needs that certificate and we will scope it with you.

Q6

Are ceramic components safe to use near implanted electronics or in an MRI environment?

A

Zirconia and aluminum nitride are non-metallic and non-ferromagnetic, so as a general material property they do not add magnetic interaction or MRI artefact the way a metal component can. Whether a specific part meets MRI-safety or MRI-conditional labeling requirements is a device-level determination made through your own testing, not a claim LONGYI is making on the material's behalf.

Q7

How do I get a quote for a bioceramic component?

A

Send a 2D drawing or 3D model with critical dimensions identified, the material family you are considering, and any quality requirement — surface finish, traceability records, or a standard the part must be qualified against. We will come back with what we can build today and what would need qualification work first.

Explore All LONGYI Ceramic Materials

Ten material families, all manufactured and machined in-house.

Also Known As

bioceramics, biocompatible ceramic, medical grade ceramic, medical-grade ceramic, implant ceramic, biomedical ceramic, 生醫陶瓷, 醫療陶瓷, 生物陶瓷, zirconia ceramic, Y-TZP zirconia, aluminum nitride ceramic, ISO 6474 alumina, ISO 13356 zirconia, non-magnetic ceramic, MRI-compatible ceramic, hermetic ceramic connector, ceramic nozzle, dental equipment nozzle, drug delivery nozzle, cardiac device ceramic component, mechanism pin, striker pin, 撞針, 心臟接頭, 洗牙機噴嘴

Parts We've Shipped

Actual production photos from the four applications above — click any image to enlarge.

Zirconia — Cardiac Connector Cardiovascular Device Connector
Three white zirconia cardiac connectors with ribbed grip sections
Three zirconia cardiac connectors showing cross-drilled bore ends

Circumferential grip ribs increase mechanical purchase for assembly without an added collar, and the elongated slot lets the mating pin float across the ceramic-to-metal expansion mismatch without stressing the connector. Cross-drilled bores are held to close positional tolerance so the mating lead seats consistently on every unit — the application that has shipped continuously since 2017.

Zirconia — Ceramic Valve Rotary Valve Assembly
Ivory zirconia valve sleeve and rotor shown as a separated two-piece set
Zirconia valve sleeve with two cross-drilled ports beside its rotor
Zirconia valve rotor with machined locating groove beside its sleeve

Ported outer sleeve and slotted inner rotor, machined to mate on both surfaces so the rotor indexes flow paths without leaking past the joint. Cross-drilled ports through the sleeve wall align with the rotor's internal channel only at set rotation angles, and a machined locating groove on the rotor sets its rotational reference so the flow channel returns to the same port position on every cycle.

Zirconia — Ellipse Nozzle Injection / Mixing Nozzle
Two zirconia nozzles laser-marked with 70um and 100um orifice sizes
Industrial CT scan of a zirconia nozzle showing taper to a rounded tip

Orifice size is laser-marked directly on each nozzle — 70 µm and 100 µm shown — keeping units identifiable at the point of use where dosing accuracy depends on bore size. Taper angle and tip radius are verified non-destructively by industrial CT scan before release, since this geometry is difficult to confirm with contact measurement alone.

Aluminum Nitride — Mechanism Pin Medical Device Mechanism Pin
Ivory aluminum nitride mechanism pins with tapered pointed tips
Close-up of two aluminum nitride pin tips showing ground point geometry

Slender tapered profile minimizes contact area and insertion force at the point of repeated actuation, while AlN's hardness and dimensional stability resist wear over the pin's service life. Tip radius and taper are precision-ground rather than left as-sintered, since point geometry directly controls insertion force and localized wear at first contact.

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