Custom Medical & Biocompatible Components: Skin-Interface, Surgical, Wound-Care & Sterile-Barrier

Biocompatibility is not a single yes-or-no property of a material; it is an evaluation against a framework for a specific body contact. A material is evaluated against the relevant parts of ISO 10993, and often the USP Class VI plastics screen, for a defined contact type (intact skin, mucosa, breached surface) and duration (limited, prolonged, permanent). A grade fit for short skin contact is not automatically fit for a wound or an implant contact, because the applicable tests change with the contact.

So the right question is never just "is this biocompatible," but "is this grade evaluated as acceptable for my contact type and duration." That evaluation lives on the material manufacturer's data sheet; the conclusion for the finished device lives with the device maker.

They are related but different. ISO 10993 is the international, multi-part framework for the biological evaluation of medical devices; it does not give one universal pass, because the relevant parts (cytotoxicity, sensitization, irritation, and others) are selected by the contact type and duration of the specific use. USP Class VI is a United States Pharmacopeia biological reactivity test class for plastics, the most demanding of the USP classes, and it is a defined set of tests a material can be evaluated to as a screen.

In practice, many medical-grade materials carry both: a USP Class VI result as a material screen and an evaluation against the relevant ISO 10993 parts. Both are material-level frameworks; neither is a clearance of a finished device, which is a separate, device-level evaluation the device maker owns.

No, and that line matters. H-O is a precision converter. We convert materials whose manufacturers report evaluation against ISO 10993, USP Class VI or FDA frameworks, and we provide material traceability and lot-level data-sheet records for the parts we make. But the biocompatibility and regulatory clearance of the finished medical device, including the device-level biological evaluation for its specific use, is owned and validated by the device maker.

The honest framing throughout this page is that the material is evaluated against the cited frameworks by its manufacturer, and H-O converts that material to your drawing; the device-level conclusion is yours. We are glad to share the material documentation that supports your file and to work to your converting and traceability requirements.

They are the first and biggest levers. Contact type, whether the part touches intact skin, a mucosal surface, or a breached or compromised surface, and contact duration, whether limited (up to 24 hours), prolonged (up to 30 days), or permanent, together determine which parts of ISO 10993 apply and how stringent the material evaluation must be. A short skin-contact cushion has a relatively limited evaluation; a wound dressing that contacts a breached surface for days has a more stringent one.

So we start every recommendation from the contact: it narrows the material families and tells you which grade evaluation to ask the manufacturer for. Send the contact type and duration first, and the job, the cleaning method and the adhesion need next, and the family direction follows.

Because of the cure chemistry. Silicone can be cured with a peroxide catalyst or with a platinum catalyst (an addition cure). Platinum-cured grades, such as SSP-2390, do not leave the peroxide cure by-products that a peroxide cure can, so they give cleaner, lower-extractable parts, which is desirable for medical contact. Platinum-cured silicones also generally hold their properties across a wide temperature span and tolerate repeated sterilization well.

That combination, clean cure chemistry plus sterilization tolerance, is why platinum-cured solid silicone is favored for instrument grips, gaskets and seals, and why medical silicone grades in general are the move when a part must be cleaned and sterilized repeatedly. Confirm the cure type, the reported evaluation and the sterilization compatibility for the specific grade on the data sheet.

It depends on the method and the grade, but silicones are generally the most tolerant. Autoclave (steam) heat, gamma or e-beam radiation, and ethylene-oxide gas each stress materials differently, and a grade has to survive the chosen method and the number of cycles without losing its properties. Medical silicones, both the soft foams and the solid platinum-cured grades, generally tolerate repeated autoclaving, gamma and EO well, which is a major reason they lead for reusable surgical instrument parts.

Some foams, including certain polyurethanes, are better suited to single-use or to a specific sterilization method rather than many repeated cycles. The only reliable answer is the grade data sheet: confirm the sterilization method, the temperature and the cycle count the grade is rated for, and design the part and any adhesive to that. Tell us the method and the cycles and we will match a grade.

Soft, conformable, low-set foams in grades evaluated for skin contact. PORON Medical microcellular polyurethane is a lead for a thin, durable, controlled cushion that holds a comfortable feel without taking a fast set, and a soft medical silicone foam suits soft, breathable, skin-contact interfaces, while the solid BISCO MS-1600 grade suits skin-side gaskets and seals.

The cushion is usually paired with a skin-side adhesive chosen for the wear time you want, gentle and repositionable for short wear, or longer-wearing for multi-day use, and sometimes a face film or carrier.

The same skin-interface parts appear in on-body consumer electronics as well as in medical wearables. Send the contact type and duration, the wear time, the desired feel and the adhesion requirement, and the foam softness, the grade and the adhesive system can be matched against the data sheet.

Open-cell foams that manage fluid, in grades evaluated for the breached-surface contact. Wound-care and negative-pressure wound therapy components absorb exudate, wick and distribute it, and in NPWT carry negative pressure across the wound bed, so the lead material is an open-cell reticulated polyurethane whose through-porous structure takes up and moves fluid.

Because the part contacts a breached or compromised surface, the biological evaluation is more stringent than for an intact-skin part, so the grade must be one the manufacturer evaluates against the relevant ISO 10993 parts for that contact.

Soft medical silicone foam is also used for gentle, skin-contact border or contact layers. H-O converts the evaluated material to the dressing or NPWT outline; the finished dressing or therapy system is qualified by its maker. Send the construction and the contact, and we will match the foam and the layers.

A few things move a recommendation from a guess to a real direction: the contact type (intact skin, mucosa, breached surface, or no patient contact) and the duration (limited, prolonged, permanent), the mechanical job (cushion, seal, fluid layer, padding, or barrier), the cleaning or sterilization method and cycle count, any adhesion requirement (skin side, device side, or both), and the evaluation framework the part must satisfy (ISO 10993 parts, USP Class VI, or an FDA fluid-contact basis).

Add the part geometry or a drawing, the desired feel or firmness, and the prototype and annual volume, and engineering can match a family, a grade direction and a converting approach, then confirm the grade-level values and the reported evaluation against the manufacturer's data sheet. The "What to send H-O" box below lists these. If you only know the symptom or the device, that is a fine starting point too; describe it and we will work back to the spec.

H-O is a precision converter, not a raw-material producer. We do not extrude, mold, cast or compound the foam and silicone; we buy sheet, slab and roll stock from the material manufacturers and convert it to your drawing, by die-cutting, kiss-cutting, laser and waterjet cutting, adhesive lamination, slitting and kitting, under our ISO 9001:2015 certified quality management system with material traceability and lot-level data-sheet records.

Every medical and biocompatible part is made-to-order; we do not carry finished parts in stock and we do not advertise a no-minimum policy, though prototype quantities through full production runs are equally welcome and the minimum varies by material and part. Prototype and production timing is summarized in the process strip near the top of the page and on the quote form.

Send your drawing or describe the device through the form below for a specific quote. The device-level biocompatibility and regulatory file remains yours.

Yes. Laminating the skin-side adhesive, the device-side bond and the release liner into one or kiss-cut stack is core converting work: the part arrives ready to peel and place, with pull tabs on the liner where the drawing calls for them. Specify the skin-side adhesive by wear time and removal, and the device-side bond separately; both live in the same laminate and are confirmed at quote.

Material traceability and lot-level data-sheet records, kept under our ISO 9001:2015 certified quality management system: which manufacturer lot went into which shipment, with the grade's technical data sheet on file. What H-O does not supply is device-level documentation — the biocompatibility conclusion, sterilization validation and any regulatory clearance for the finished device belong to the device maker.

Kiss-cutting cuts through the foam and adhesive but leaves the release liner intact, so parts ship as peel-and-place pieces on a continuous liner — with pull tabs where the drawing calls for them. It is the standard format for skin-interface cushions and adhesive-backed pads in assembly, because the operator or the end user peels the part without hunting for an edge.

It is shorthand for a grade whose ingredients or formulation align with an FDA food- or fluid-contact regulation named on the manufacturer's data sheet — not a device clearance and not an FDA approval of the material. It answers a different question than ISO 10993 or USP Class VI: the right basis depends on whether your contact is fluid-path, food-contact or biological. Check which regulation the data sheet actually cites and match it to your requirement.