Gaskets

Foam gaskets for medical devices

Medical device foam gaskets are cut from silicone or urethane foam whose maker publishes biocompatibility data for the grade, such as BISCO® MS silicones and PORON® Medical urethanes from Rogers Corporation. They seal housings, covers and panels, cushion pads and parts, and damp sound and vibration in equipment that is wiped down with hospital cleaners. Conquest Seal buys the sheet from the maker or its distribution network and cuts the gasket to your drawing on its own waterjet, open-cell foams included. The test data belongs to the maker's grade; Conquest does not test or certify biocompatibility, and a certificate of conformance ships with every order.

Request a quote with your drawing All gasket materials

Materials: Silicone foam, sponge and solid; microcellular urethane
Maker lines: BISCO MS silicones and PORON Medical urethanes, from Rogers
Test evidence: The maker's USP Class VI or ISO 10993 data for the grade
Who tests: The material maker; the device maker evaluates the device
Paperwork: Certificate of conformance with every order; maker documents on request
Product: Gaskets cut to your drawing on our own waterjet, open-cell foams included

What a medical foam gasket has to prove

For a medical gasket, the outline is the easy part. The work is in showing that the foam has been tested for the contact it will have, and keeping that evidence with the lot. Test reports are issued by the material maker for a specific grade, so a quote names the maker and the grade rather than a material family. Ask for the grade the maker has tested to the standard your program works to, and the documentation comes with it.

Foams makers test for medical devices

The table covers two families: silicone, for its inertness and temperature span, and microcellular urethane, for cushioning and low compression set. The table sets out what each maker states for its own grades, in our words; the statement belongs to the grade the maker names, not to the family.

Maker statements for medical and life-science foams, as published by Rogers Corporation [S1, S2, S3] and in the Rogers data sheets named in the rows [S8, S9]; the maker's current documentation for the grade you order governs
Material	What the maker states	Typical device use
BISCO MS silicones (Rogers)	Platinum-cured silicone as open-cell foams, buns and solids, a line Rogers calls "highly resistant to UV, ozone, and most popular hospital sanitizers" [S1]. The 2023 sell sheet lists ISO 10993, USP Class VI and 21 CFR 177.2600 as testing in process for select grades [S1]. The later MS-1600 solid silicone data sheet [S8] states the finished product was tested to meet USP Class VI and complies with 21 CFR 177.2600, and the MS bun series sheet [S9] states 21 CFR 177.2600 compliance for its open-cell buns.	Seals and gaskets on bioprocess and pharmaceutical equipment; pads that soak up noise or keep vibration out of a device
PORON Medical urethanes (Rogers)	Open-cell, breathable microcellular urethane in soft cushioning and soft supporting formulations; the Rogers sheet gives ISO 10993-10 (2010) primary skin irritation as a pass, and rates its hydrolysis resistance, tested after an autoclave cycle, as good [S2].	Cushions and pads that touch skin
Closed-cell silicone sponge	The medium and firm grades are named by SAE AMS3195 and AMS3196 [S4, S5]; biocompatibility data is not assumed for these grades, so ask the maker for a grade tested to your standard.	Housing, door and cover seals that must keep water and cleaning fluids out

Where medical foam gaskets are used

These are the uses the foam makers name for these grades, in general terms. The grade on the print, and the maker's data for it, decide whether a foam fits a given device.

Housing, door and cover seals that keep dust, water and cleaning fluids out of equipment that is opened and closed often [S1].
Gaskets on bioprocess and pharmaceutical equipment, where the maker's USP Class VI statement is part of the file [S1, S3].
Acoustic and vibration pads inside powered equipment, where open-cell silicone foam absorbs noise and isolates vibration [S1].
Cushions and pads that touch skin, in breathable open-cell urethane that carries the maker's skin irritation result [S2].

USP Class VI and ISO 10993

USP Class VI comes from the United States Pharmacopeia and classes plastics by their biological reactivity in vivo [S3]. As Rogers describes it, Class VI is the most demanding of the six USP classes and rests on three in vivo tests: systemic injection, intracutaneous reactivity and implantation [S3]. ISO 10993 is the ISO series on the biological evaluation of medical devices; its Part 1 sets out how a device's biological safety is assessed within a risk management process [S6]. Rogers' bulletin rates USP Class VI as much less demanding than ISO 10993, and points to ISO 10993 as the requirement for devices that are implanted for long periods or for good [S3]. In both cases the material data supports the device maker's own evaluation of the finished device; it does not replace it.

Cut to your drawing on our own waterjet

Medical foam gaskets, open-cell foams included, are cut to your drawing on Conquest Seal's own waterjet, from BISCO MS or PORON Medical sheet bought from the maker or its distribution network to the grade on your print. There is no die to build, so a prototype run and a repeat order go through the same setup. On thick foam the jet leaves a clean, square edge, where a steel-rule die can leave it concave [S7]. The thickness and tolerance for a job are confirmed on the quote rather than published here; typical industry waterjet figures are on the custom gaskets page.

Documents that come with the gasket

A medical foam gasket travels with paperwork that ties the part to the maker's grade and lot. Which maker documents exist depends on the grade, so the quote names them. Orders are handled under Conquest Seal's AS9100D quality management system, whose certificate scope includes distribution.

Certificate of conformance. Ships with every order, naming the part number, the specification, the maker, the lot and the quantity; the compliance documents page shows what it carries.
The sheet maker's certificate. The foam maker's certification for the sheet lot the gasket was cut from, on request.
The maker's biocompatibility statement. Where the maker publishes one for the grade, such as Rogers' USP Class VI bulletin for BISCO MS silicones [S3] or the ISO 10993-10 skin irritation result on the PORON Medical data sheet [S2]. The statement is the maker's, not Conquest's.
Lot traceability. The gasket's lot traces back to the maker's sheet lot, so a question about a batch can be answered from the records.
RoHS, REACH and conflict minerals statements. On request, for the grade on the order.

What to send

A medical foam gasket is quoted from the drawing and the grade. These items settle the quote and the paperwork together.

The drawing. A DXF, DWG or PDF of the outline, with the thickness the print states.
The grade. The foam maker and grade number, because the test data belongs to a specific grade; if the print names only a family, say so and the quote names the tested grades available.
The standard. What the program needs from the material: USP Class VI, a named part of ISO 10993, or both.
The service. Whether the gasket touches skin or fluids, how the device is cleaned or sterilized, and the temperature it sees.
The adhesive. Yes or no, and which face.
The quantity. The order quantity now and the annual usage if it repeats.
The paperwork. A certificate of conformance ships with every order; say if the program also needs the sheet maker's certificate or the maker's biocompatibility statement for the grade.

Frequently asked

Does Conquest Seal certify foam for medical use?

No. USP Class VI and ISO 10993 data come from the material maker for a specific grade, and the device maker evaluates the finished device. Conquest Seal supplies the maker's grade with the maker's documentation and a certificate of conformance.

What is the difference between USP Class VI and ISO 10993?

USP Class VI classifies plastics by biological reactivity through three in vivo tests. ISO 10993 is the series of standards for evaluating the biological safety of medical devices, and Rogers describes it as the more stringent of the two.

Which foams are used in medical devices?

Silicone foams and sponges, for inertness and a wide temperature span, and microcellular urethanes such as PORON Medical, for cushioning and low compression set. The grade the maker has tested is what goes on the print.

What documents come with a medical foam gasket?

A certificate of conformance with every order, naming the part number, the specification, the maker, the lot and the quantity. The sheet maker's certificate for the lot, and the maker's own biocompatibility statement for the grade where it publishes one, come on request.

Can you supply BISCO MS and PORON Medical as cut gaskets?

Yes. Conquest Seal buys BISCO MS silicone and PORON Medical urethane sheet from the maker or its distribution network and cuts the gasket to your drawing on its own waterjet.

Can a foam gasket be autoclaved or sterilized?

It depends on the grade and the method. The PORON Medical data sheet reports hydrolysis resistance after autoclaving, and the maker's sheet for your grade is the place to check; say how the device is sterilized on the request.

Is thick foam cut on the waterjet?

Thick, soft foam is where the waterjet does better than a die, because the jet leaves a square edge where a die would pinch the sheet. Open-cell and closed-cell foams are both cut on our own waterjet; give the thickness on the drawing and the quote confirms the grade and the sheet.

Do medical foam gaskets come with adhesive?

They can. The sheet maker laminates the adhesive to one face and the gasket is cut with the liner on; if the adhesive side touches skin or fluid, name that on the request so the adhesive's own data is part of the quote.

Sources

[S1] BISCO MS Silicones sell sheet, publication 180-402, Rogers Corporation, 2023, read 2026-09-25.
[S2] PORON Medical Urethanes, Soft Cushioning and Soft Supporting typical physical properties, publication 10-017, Rogers Corporation, 0315, read 2026-09-25.
[S3] USP Class VI and BISCO MS Silicone Compliance technical bulletin, publication 180-432, Rogers Corporation, 2024, read 2026-09-25.
[S4] SAE AMS3195: Silicone Rubber Sponge, Closed Cell, Medium, read 2026-09-25.
[S5] SAE AMS3196: Silicone Rubber Sponge, Closed Cell, Firm, read 2026-09-25.
[S6] ISO 10993-1: Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process, read 2026-09-25.
[S7] Waterjet Cutting, Stockwell Elastomerics, read 2026-09-24.
[S8] BISCO MS-1600 Series Medical and Life Science Solid Silicone product data sheet, publication 180-358, Rogers Corporation, 2020, 2022, 2024, 2026, read 2026-09-27.
[S9] BISCO MS Bun Series Medical and Life Science Grade Cellular Silicones product data sheet, publication 180-404, Rogers Corporation, 2023, read 2026-09-27.

Stated in our own words from the sources above; no standard's text or table is reproduced.

PORON and BISCO are trademarks of Rogers Corporation. No affiliation or endorsement is implied.

Related guides

Send the medical foam gasket drawing

Upload a DXF, DWG or PDF with the quote request. Add the foam maker and grade, the standard the program needs, the thickness, whether adhesive backing is wanted, and the quantity. Gaskets are cut on our own waterjet; a Conquest representative replies with the quote and the maker's documentation.

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Last updated September 28, 2026