Surgical Instruments & Tools

Medical silicone leads for repeated steam autoclave. A platinum-cured solid silicone (SSP-2390 or BISCO MS-1600) gives a non-porous, low-extractable seal that tolerates steam, ethylene oxide, gamma, and e-beam per the maker TDS, and a medical cellular silicone (BISCO MS-80 / MS-96) gives a compressible gasket that seals under modest force. The number of cycles matters as much as the method: a seal that survives one autoclave can take a compression set over hundreds, so choose a grade and a construction that recover over the life and state the cycle count on the drawing.

Where gamma is used, verify the dose limit, because high-dose gamma crosslinks and stiffens silicone. For a chemistry or a temperature beyond silicone's range, a USP Class VI FFKM is the step up. Compression set is characterized per ASTM D395 and cellular properties per ASTM D1056; grade-specific limits are per the TDS on file. The grade is referenced to ISO 10993 and USP Class VI by designation; H-O is an ISO 9001:2015 certified converter and does not certify finished devices.

Use a platinum-cured silicone for a seal in a clean fluid path or where low extractables matter, which covers most surgical-instrument seals. Platinum curing is an addition reaction that leaves no peroxide by-products and gives low migratable silicones, so the seal is less likely to release substances into the fluid path under heat and over time. SSP-2390 and BISCO MS-1600 are platinum-cured medical silicones.

A peroxide-cured silicone can leave cure by-products, which is why it is avoided where the seal contacts a sensitive fluid path. The deciding question is whether the seal contacts a clean fluid path and whether low extractables are required; if so, specify platinum-cured. Extractables behavior is a material-level property the material maker characterizes; the device maker assesses the extractables and leachables for the finished device.

The grades are documented by their makers to USP Class VI and FDA 21 CFR 177.2600 (food-contact); ISO 10993 evaluation of the finished part is the device maker’s responsibility.

Use a USP Class VI FFKM (perfluoroelastomer) when the working chemistry, a solvent, or a temperature exceeds what silicone tolerates. Silicone handles steam, ethylene oxide, and gamma and a broad range of chemistries, but it is not the right choice for some aggressive solvents or for temperatures above its range, where it can swell, soften, or degrade. An FFKM resists a very broad chemistry and a high temperature, and a USP Class VI medical grade is available by designation for a contact part.

The trade-off is cost: FFKM is a premium elastomer, so it is reserved for the seals that genuinely need its chemical and temperature resistance, while a platinum-cured silicone handles the clean fluid-path seals within silicone's range at a lower cost. Name the fluids, solvents, and the maximum temperature the seal contacts so the right elastomer is chosen. Chemical resistance and the USP Class VI designation are maker-TDS properties referenced by designation; H-O the FFKM to the seal geometry.

Yes, it is one of the most important decisions, because it narrows the material as much as the function does. A single-use part is used once and discarded, so it can use a wider, often lower-cost material set and does not have to survive repeated sterilization. A reprocessed part is cleaned and sterilized between every use, hundreds of times over its life, so it needs a grade and a construction that recover over that many cycles without taking a compression set, hardening, or degrading.

A seal that survives one autoclave can fail over hundreds, a cushioning foam can harden, and a tray liner can break down, so the cycle count is part of the spec. State the lifecycle and, for a reusable part, the expected number of cycles, so H-O matches the grade to the duty rather than to the function alone. The reprocessing durability is a maker-TDS property; this page frames it qualitatively and defers grade-specific limits to the TDS on file.

For a grip that is sterilized with the instrument, use a sterilizable cushioning material: a soft silicone foam gives a cushioned grip surface that tolerates the silicone-compatible cycles, and a firmer solid silicone gives a fully cleanable, wipe-down grip where deep cushioning is not the point.

A PORON medical microcellular polyurethane gives controlled cushioning with low compression set and is the industry-standard cushioning polyurethane, but it is often single-use or limited-reprocessing, so for a reusable autoclaved grip verify its reprocessing tolerance on the maker TDS or choose a silicone.

The deciding questions are the lifecycle (single-use or reprocessed and how many cycles), the feel and force-deflection you want, and whether the surface has to be cleanable. A cushioning material not chosen for the reprocessing duty can harden and lose its feel, so state the lifecycle and the cycle count. Cushioning recovery is a maker-TDS property; this page frames it qualitatively.

It depends on the foam and the method. A crosslinked polyethylene foam and an EVA foam make durable, protective tray liners and tolerate ethylene oxide and limited gamma, but they do not tolerate repeated steam autoclave at the rate silicone does, so a liner sterilized in steam with the set will degrade over time. Where the tray and liner are autoclaved with the set, use a sterilizable silicone foam for the cushion, which tolerates the silicone-compatible cycles.

Where the liner is a shipping or storage insert that is not sterilized, or is sterilized only by ethylene oxide or limited gamma, a crosslinked polyethylene insert with an EVA cushion layer is the durable, lower-cost choice. State the lifecycle, the sterilization method, and whether the liner is reprocessed with the set, so the foam grade matches. The foam properties are characterized per ASTM D1056; H-O the liner to the tray and the cavity layout.

H-O references material grades by designation and assembles documentation aligned to your requirements. State the contact type, the duration, and the basis you need, ISO 10993 endpoints (for example cytotoxicity, sensitization, irritation, and deeper endpoints for longer or internal contact), a USP Class VI designation, or an FDA contact basis, and H-O sources a grade whose maker evaluates it against those frameworks and provides the material TDS, certificate of conformance, and lot traceability.

The important distinction is who owns what: the material maker evaluates the grade at the material level, and the device maker owns the finished-device biocompatibility and regulatory file. H-O is an ISO 9001:2015 certified converter; it does not independently certify materials and does not certify finished devices, and it does not claim an ISO 13485 certification, an FDA device registration, or a cleanroom certification.

Customer-specified compliance packages are assembled on request, and for a surgical contact part the contact basis should be stated up front so the grade is referenced correctly.

The usual cause is compression set: an elastomer held compressed at temperature gradually loses its recovery, so after many autoclave cycles the seal no longer springs back to fill the groove and it leaks. A grade or a construction not chosen for the cycle count, or a high-dose gamma cycle that crosslinks and stiffens silicone, accelerates it.

The fix is to choose a medical silicone selected for sterilization tolerance and low compression set (a platinum-cured solid, a solid, or a cellular silicone), state the sterilization method and the cycle count on the drawing so the maker grade matches the life, and verify the gamma dose limit where gamma is used.

If the chemistry or temperature is also a factor, a USP Class VI FFKM resists what silicone does not. Specify the cycle count and the groove geometry so H-O the seal to a grade and a construction that recover over the life. Compression set is characterized per ASTM D395; grade limits are per the TDS on file.

Yes. A grip or a pad on a surface, or a seal that sits on a flat land rather than in a machined groove, is commonly held during assembly by a pressure-sensitive adhesive on one face, and kiss-cut on a release liner so the line can peel and place it. H-O laminates the adhesive, the part outline, and kiss-cuts it on liner to your drawing.

State which face carries the adhesive and whether the part ships on a liner in sheet or roll form. Where the adhesive sits near a contact surface, name the contact basis so the adhesive is referenced to the relevant ISO 10993 part at the material level too, the same way the part is. For a seal seated in a groove with enough clamp force, no adhesive is needed.

The adhesive lamination and kiss-cut-on-liner are standard H-O converting operations, and they apply to grips, pads, and tray-liner layers as well as seals.

Silicone tolerates gamma, but the dose matters. Radiation crosslinks silicone, which raises its molecular weight and lowers its elasticity, so a high cumulative dose can stiffen the seal and reduce its recovery over time. For a single sterilization at a moderate dose this is usually not a problem; for repeated high-dose cycles, verify the dose limit and the expected property change on the maker TDS and choose a grade rated for it.

Ethylene oxide has no significant adverse effect on platinum- or peroxide-cured silicone, and steam is well tolerated, which is why silicone leads for reusable instruments. The practical rule is to state the sterilization method and the cumulative dose or cycle count on the drawing so the maker grade matches the duty; H-O references the grade and defers the dose-specific limits to the TDS on file.

This is a material-level property, not a device-level claim, and the device maker validates the sterilization for the device.

No. H-O Products is a precision converter: it makes the seals, valves, gaskets, grips, padding, and tray liners to your drawing from material grades commonly used in surgical instruments and reusable tools, under an ISO 9001:2015 quality management system. H-O is an ISO 9001:2015 certified organization; that certification governs the converting process, not a device clearance. H-O does not make finished surgical instruments and does not claim an ISO 13485 certification, an FDA device registration or clearance, or a cleanroom certification.

Material grades are referenced by designation to ISO 10993, USP Class VI, and FDA contact frameworks at the material level, where the material maker performs the evaluation. The finished-device biocompatibility, the sterilization validation, the reprocessing validation, and the regulatory file belong to the device maker. H-O supplies the converted parts, the material documentation, and lot traceability aligned to your requirements.

Send the instrument or tray drawing or a sample, the part you need, and the key facts: the job (seal, valve, or gasket; handle grip or padding; or tray liner or insert), the lifecycle (single-use or reprocessed, and for a reusable part the expected number of cycles), the sterilization method (steam autoclave, ethylene oxide, gamma, or e-beam), the contact basis (the ISO 10993 endpoints, the USP Class VI designation, or the FDA contact basis you need), and for a seal the fluids and chemistry it contacts and whether low extractables are required.

Add the geometry (seal or groove, grip outline, or tray and cavity layout), the feel or protection, any adhesive side, and the prototype and annual volume. With that, engineering returns a material family, a converted-part approach, prototype lead time, and the documentation that can be aligned to your requirements. The quote form below has fields for each of these. Samples typically ship in 3 to 5 business days; standard production in about 2 weeks.