| HS Code | 314650 |
| Density | 1.02 g/cm³ |
| Melting Point | 186 °C |
| Glass Transition Temperature | 45 °C |
| Tensile Strength | 39 MPa |
| Elongation At Break | 300 % |
| Flexural Modulus | 400 MPa |
| Izod Impact Strength 23 C | No break |
| Water Absorption 24h Immersion | 1.5 % |
| Shore Hardness | D 73 |
| Chemical Resistance | Resistant to many chemicals, alcohols, and solvents |
| Biocompatibility | Suitable for medical applications per ISO 10993 standards |
| Sterilization Compatibility | Compatible with EtO and gamma radiation |
As an accredited Arkema Rilsan BESNO MED Nylon 11 factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Supplied in sealed 25 kg bags, this medical-grade nylon 11 resin ensures purity and safe handling for healthcare manufacturing. |
| Container Loading (20′ FCL) | 20′ FCL: palletized, sealed bags of Rilsan BESNO MED Nylon 11, securely braced and ventilated to prevent moisture damage. |
| Shipping | Ship Arkema Rilsan BESNO MED Nylon 11 as non-hazardous polymer granules/powder. Use clean, dry, moisture-proof packaging; avoid high temperatures and humidity. Keep upright, protect from impact, and store in ventilated area away from ignition sources. No special transport classification required, but handle with standard industrial safety precautions. |
| Storage | Store Arkema Rilsan BESNO MED Nylon 11 in its original, unopened packaging in a cool, dry, well-ventilated area. Keep away from direct sunlight, heat sources, and moisture. Maintain moderate humidity to prevent water absorption. Avoid contamination with dust, chemicals, or foreign materials. Under proper conditions, shelf life is typically two years from date of manufacture. |
| Shelf Life | Arkema Rilsan BESNO MED Nylon 11 has a shelf life of 3 years when kept dry, cool, and sealed in original packaging. |
Pellet feedstock is introduced to the hopper after desiccant-bed drying at 80 °C for 4–6 h until residual moisture is below 0.05 wt%; inlet air is held at a dew point below -30 °C. In single-screw extrusion on a 25–32 mm screw with L/D 24:1 and a compression ratio of 2.8:1, the barrel profile is set from 220 °C at the feed throat to 245 °C at the metering zone, with the die head maintained at 215–230 °C. For catheter shafts of 1.0–3.0 mm outside diameter and 0.15–0.40 mm wall thickness, a gear pump is operated at constant melt pressure to suppress die-lip surge, while vacuum sizing is held at -20 kPa to -30 kPa. The annular draw-down ratio is kept below 1.6:1 to avoid lumen collapse and inner-wall fibrillation.
When radiopacity is required, the filler is not dry-blended at the hopper unless the particle size distribution is controlled below 5 µm D50. Instead, a barium sulfate masterbatch in PA11 carrier is pre-compounded to prevent screw slippage and melt-pressure oscillation. The addition ratio is typically 8–20 wt% BaSO4 equivalent in the finished tube, with Rilsan BESNO MED at 78–92 wt% and processing stabiliser masterbatch at 0–2 wt%. Above 15 wt% filler, screw torque rises and melt fracture onset shifts to lower line speeds; on a 25 mm line, production often reduces line speed from 30–40 m/min to 20–30 m/min to maintain a visually smooth bore, although published data for this specific filler-resin configuration are limited. Additives that raise melt viscosity, including high-molecular-weight silicone lubricants, are avoided because they increase internal shear heating and contribute to yellowing during extended runs.
Compliance for this tubing class is anchored to ISO 10993-1:2018 biological evaluation planning, ISO 10993-5:2009 cytotoxicity, ISO 10993-10:2010 irritation and sensitisation, and USP <87> / USP <88> Class VI biological reactivity for transient patient contact. If the tube is used in vascular access, finished-device testing requirements apply beyond resin-level certifications. Terminal products manufactured from this configuration include introducer catheter shafts, peripheral intravenous catheter bodies, urinary drainage catheters, and enteral feeding tubes where kink resistance and solvent-free assembly are specified.
Injection moulding of male and female Luer bodies from Rilsan BESNO MED is carried out on hydraulic or all-electric machines with clamp force selected on projected area. For an eight-cavity cold-runner tool, clamp force is commonly specified at 120–180 t when individual part projected area is below 12 cm²; hot-runner valve-gate systems reduce gate blush but require melt temperatures of 235–260 °C. The 6 % Luer taper in ISO 80369-7:2016 contains dimensional limits for engagement length and diameter at defined datum positions, with production drawings frequently controlling the small-end diameter to ±0.01 mm. Post-demoulding crystallisation continues for several hours, shifting the internal diameter toward the lower tolerance band if immediate gauging is used. Parts are therefore held at 23 °C and 50 % RH for at least 24 h before final dimensional verification.
Formulation addition ratio in connector bodies is deliberately narrow. The resin is processed neat or with a PA11-compatible colour masterbatch at 2–4 wt% for white or blue identification. Silicone-based mould-release sprays are prohibited because they migrate to the sealing surface and create leakage paths under intermittent pressure. If radiopaque connectors are required, barium sulfate masterbatch at 10–20 wt% is used, but crystallisation behaviour changes slightly and moulding parameters are re-validated by measuring dimensional recovery after steam sterilisation. Amine-based internal lubricants are avoided because they interfere with crystallisation and can stress-crack the gate area after repeated use.
The downstream process includes a high-velocity first-stage injection to fill the thin gate region, followed by a second-stage hold pressure of 50–70 MPa maintained for 2.0–3.0 s after gate freeze. Pre-drying at 80 °C for 4 h is mandatory; moisture above 0.08 wt% causes hydrolysis at the hot runner and splay on the sealing face. Terminal products include male and female Luer connectors, three-way stopcocks, Y-site connectors, and dialysis effluent line adapters. Compliance is demonstrated through ISO 80369-7:2016 dimensional and leak testing, ISO 10993-5:2009 cytotoxicity, and USP <87> / USP <88> Class VI for patient-contacting components.
Insert moulding of Rilsan BESNO MED over stainless steel shanks is performed on vertical injection machines with rotary tables, where preheated metal inserts are loaded automatically. Insert temperature is held at 120–160 °C to reduce the thermal gradient at the polymer-metal interface and avoid quench-layer peeling. The resin is moulded at 240–260 °C; tool temperature is maintained at 60–80 °C with pressurised water. Because PA11 has lower equilibrium water absorption than PA6 or PA66, handle-body cross-sections of 3–6 mm can be used without excessive dimensional growth after steam sterilisation. However, moulded-in metal inserts create biaxial orientation at the gate, and steam exposure at 134 °C for 4–18 min releases these stresses as radial growth, leading to loosening if knurl depth is below 0.3 mm.
The formulation addition ratio for this process is neat resin, optionally with 2–3 wt% house masterbatch for black or dark-blue instrument identification. External lubricants are not added because they wash out under steam and alter gloved-surface friction. The critical compliance standards are ISO 17665-1:2006 for moist heat sterilisation validation, ISO 10993-5:2009 for cytotoxicity after extract preparation, and FDA 21 CFR 177.1500 when the component is considered a food-contact surface in dental or veterinary handpieces that enter the oral cavity.
Terminal finished products include reusable surgical instrument handles, dental scaler handpiece shells, orthopaedic pin guides, and hinged instrument cases. In production, the most frequent failure is not polymer degradation but insufficient insert preheating; if inserts fall below 110 °C, pull-away voids form at the metal-polymer boundary and are detected only after external steam cycling. Gate placement on the opposite side of the insert reduces jetting. Post-mould annealing at 120 °C for 2 h is applied only for flat inserts; for long thin instruments, annealing is omitted to preserve straightness.
Short-duration drug-contact fluid pathway components are moulded in ISO Class 7 cleanrooms from Rilsan BESNO MED when the finished device is limited to less than 30 min continuous patient contact and is not used for implantable or long-term critical applications. The primary compliance matrix is USP <661.1> physicochemical testing for plastic packaging and delivery systems, supplemented by ISO 10993-5:2009 and ISO 10993-18:2020 chemical characterisation for leachables. Because PA11 may contain residual monomers and cyclic oligomers, hot-water extraction at 70 °C for 24 h is used as a worst-case model for moderate-temperature aqueous drug contact. When components handle lipid-containing formulations, a separate ethanol/water extraction is performed according to ISO 10993-18:2020.
Formulation addition ratio is kept deliberately narrow: the resin is used as delivered, with post-compounding only if a colour masterbatch is required at 1–2 wt%. Erucamide-based lubricants are not added because they raise organic extractable content and shift the leachable profile toward out-of-specification values for low-volume parenteral line components. Melt temperature is set at 235–250 °C, and tool temperature is 40–60 °C on cleanroom-dedicated all-electric machines with oil-free linkage. Forehearth drying at 80 °C for 4 h is required; moisture above 0.06 wt% causes hydrolysis-induced viscosity loss and increases low-molecular-weight extractables. Terminal components include infusion pump valve bodies, rotary adapter rings, check-valve housings in enteral pump sets, and short-term contrast-media manifold connectors. Because dimensional stability after gamma irradiation at 25–40 kGy can be dose-dependent, radiation-sterilised lots are evaluated for colour shift and embrittlement before release.
Rilsan BESNO MED is selected for moulded diagnostic cartridges and respiratory manifold housings when assembly requires solvent-free permanent joining. The downstream process is a two-part injection moulding operation: top and bottom shells are produced in a 4- to 8-cavity tool, then joined on a 20 kHz or 30 kHz ultrasonic welder with horn stroke accuracy of ±0.01 mm. Energy directors are moulded with a 45° apex angle and height of 0.25–0.50 mm. With semi-crystalline PA11, the energy director height must be compensated because the polymer absorbs part of the ultrasonic energy as viscous heating before the weld bond reaches melt temperature. Welding time is typically 0.15–0.40 s, and holding time after collapse is set at 0.50–1.00 s.
Formulation addition ratio in this scenario is neat resin to reduce acoustic attenuation; fillers or glass fibres are not used in the weld region because they alter energy director collapse and produce particulate ejection along the weld line. A PA11-compatible colour masterbatch at 1–2 wt% is acceptable if masterbatch moisture is below 0.05 wt%. Industry compliance standards are ISO 10993-1:2018 and ISO 10993-5:2009 for patient-contact diagnostics, plus ISO 13485:2016 process validation for welding, labelling, and cleanroom assembly.
Terminal product types include in-vitro diagnostic test cassettes, respiratory humidifier manifold covers, non-invasive blood-pressure transducer housings, and detector cell bodies. A production bottleneck occurs when ultrasonically welded shells are not annealed before welding; residual moulded-in stress from gate areas can cause hairline fractures at the weld edge during thermal cycling. Operators dry welded components for 2 h at 80 °C before welding if ambient relative humidity exceeds 60 %.
Pressurised fluid handling components made from Rilsan BESNO MED are used in medical equipment housings where intermittent pressure spikes below 300 kPa are encountered. The production process includes semi-crystalline injection moulding followed by post-mould annealing to stabilise dimensions before machining of sealing lands. Annealing is performed in air-recirculating ovens at 120 °C for 1.5–2.0 h; slow cooling at 0.5 °C/min to 50 °C reduces internal stress near the gate. Without annealing, a PA11 valve body exposed to 50 °C and 70 % RH reaches equilibrium water content slowly, but the dimensional change is non-uniform across thick and thin sections, causing the sealing face to lose flatness.
Formulation addition ratio is neat polymer for the body, with a laser-marking masterbatch at 0.5–1.0 wt% for UDI codes; the laser-marking package must be free of heavy metals to satisfy EU RoHS 2011/65/EU and medical waste stream requirements. Compliance is documented under ISO 10993-5:2009, ISO 10993-10:2010, and ISO 80369-7:2016 for Luer interface compatibility. Terminal components include high-pressure contrast injection valve bodies, haemodialysis line pressure domes, and enteral feeding pump cassettes. The resin is not used for prolonged steam contact above 134 °C because oxidative stabilisation is limited; repeated exposure to hydrogen peroxide plasma at 45–55 °C is accepted only after lot-specific compatibility testing.
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Arkema Rilsan BESNO MED is a natural-color, unplasticized polyamide 11 resin manufactured from 11-aminoundecanoic acid derived from castor oil. The BESNO portion of the grade name identifies the base polyamide 11 product family; the MED suffix denotes a medical formulation in which lot documentation, change-management obligations, and biological-test support are maintained for device manufacturers. The resin is a medium-viscosity grade intended for injection molding, tube extrusion, profile extrusion, and blow molding. It is specified in applications where moderate stiffness, dimensional stability, low moisture uptake relative to polyamide 6 and polyamide 66, and compatibility with ethylene oxide sterilisation are required under device-specific regulatory control.
The material is supplied as pellets and is not a formulated compound containing ortho-phthalate plasticisers. Incoming material should be identified by grade name on both packaging and certificate of analysis. Relative solution viscosity measured in m-cresol under ISO 307 is the principal incoming-control parameter for molecular weight. A shift larger than ±5% from the assigned release value is a warning signal for contamination, moisture degradation, or thermal history abuse. Moisture content above 0.10 wt% at the feed throat is a known cause of splay, viscosity loss, and surface defects on production lines.
Published datasheet values for Rilsan BESNO MED are typically generated on dry-as-molded specimens. The following table consolidates standardised reference values used for first-article approval. Values are typical, not batch-release limits; the current manufacturer datasheet and internal release certificate remain controlling.
| Property | Method | Typical reference value |
|---|---|---|
| Density | ISO 1183-1 | 1.04 g/cm³ |
| Melting temperature, DSC | ISO 11357-3 | 189 °C |
| Tensile modulus | ISO 527-1/-2 | 1250 MPa |
| Tensile stress at yield | ISO 527-1/-2 | 45 MPa |
| Tensile strain at break | ISO 527-1/-2 | >100 % |
| Flexural modulus | ISO 178 | 900 MPa |
| Charpy notched impact strength, 23 °C | ISO 179-1/1eA | 7–9 kJ/m² |
| Water absorption, 24 h, 23 °C | ISO 62 | 0.3–0.5 % |
| Vicat softening temperature, 50 N | ISO 306/B50 | 180 °C |
The low water uptake compared with PA6 or PA66 is a documented property of polyamide 11. At saturation, PA11 absorbs approximately 2.5 % water, whereas PA66 can exceed 8 % under equivalent conditions. This lower moisture response reduces the magnitude of dimensional change in humid clinical environments, although dimensional validation must be performed on the finished device geometry rather than inferred from raw-resin data.
Rheologically, the medium-viscosity grade is selected when a balance between pressure-based flow and melt strength is required. Melt volume-flow rate is not normally used as a release limit for moisture-sensitive PA11 because small water content shifts the value; viscosity number per ISO 307 is more reproducible for incoming control. Differential scanning calorimetry under ISO 11357-3 shows the melting endotherm and crystallisation exotherm that production engineers use to set cooling time in injection molds. Slower cooling produces higher crystallinity and greater shrinkage; annealing at 130–150 °C for approximately 2 h can stabilise dimensions in machined or molded parts.
Desiccant drying is the first process boundary. Dry-air dryers operating at 80–90 °C for 4–8 h with a dew point no higher than −30 °C reduce free moisture to below 0.10 wt%. At relative humidity above 60 %, open hoppers can re-adsorb moisture within hours; therefore the hopper should be blanketed with dry air or fitted with a closed feed system. Failure to dry produces hydrolysis in the melt, evidenced as a drop in melt viscosity, silver streaking on extrudate surfaces, and lower tensile elongation at break.
Single-screw extruders with 24:1 to 30:1 L/D ratio, three-zone screws, and screen packs of 250–500 µm are typically used for profile and tubing lines. Melt temperatures are generally set between 230 °C and 260 °C depending on screw speed and back pressure. In injection molding, barrel profiles from 240 °C to 270 °C and mold temperatures between 40 °C and 80 °C allow crystallisation without excessive post-mold shrinkage. Melt residence should not exceed 10 minutes at 260 °C; longer residence causes thermal degradation, gel formation, and black specks.
In thin-wall tube extrusion, the draw-down ratio, die land length, and vacuum calibration tank temperature are adjusted to maintain lumen stability. Melt fracture appears as fine circumferential ridges when shear stress at the die lip exceeds the melt’s critical value. Because published data for a specific die geometry is limited, start-up should map screw speed against pressure and surface quality before the normal operating window is fixed. A vacuum calibration bath at 20–40 °C is common for round profiles, while hot water baths at 60–80 °C are used for stress relief before cutting.
Injection molding of connectors and luer components is sensitive to gate design. Pinpoint gates need adequate diameter to avoid excessive shear; excessive shear produces localised melt temperatures above the barrel set point and can create yellowing or weld-line weakness. Holding pressure and cooling time are more important than melt temperature alone for sink-mark control at junction points. Typical holding pressures on small connectors are set between 60 MPa and 100 MPa; the exact value depends on flow length, wall thickness, and runner sizing.
Batch-to-batch variance in semi-crystalline polyamide 11 affects processing more through subtle shifts in relative viscosity and moisture than through changes in density or melting point. In granulate delivered to a medical device molder, relative viscosity should be monitored against the supplier’s certificate of analysis using ISO 307, and melt temperature should be re-established after a lot change. Because PA11 is synthesised from castor-derived monomer, variation in monomer feedstock can influence crystallisation behaviour slightly; however, Arkema controls the polymerisation route so that main specification limits remain within standard release ranges. If a lot shows higher than expected screw torque at the same barrel settings, moisture is the first variable to check, followed by hopper bridging and screw wear.
Screw wear on glass-free PA11 is generally low, but worn screws and barrels reduce melting efficiency and increase the risk of unmelted pellets in the part. On small injection molding machines with 20–40 mm screw diameters and 20:1 L/D ratio, dynamic feed zone temperatures may need to be 5–10 °C lower than melting zone settings to prevent premature melting and feed-blocking. Published data for a specific machine configuration is limited; process capability must be established on the actual line.
The medical documentation package for Rilsan BESNO MED typically supports biological evaluation according to ISO 10993-1:2018. The grade is commonly cited as tested to ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation and skin sensitisation, and USP <88> Class VI biological reactivity. Because the formulation is unplasticised, it eliminates ortho-phthalate plasticiser concerns during extractables assessment. The base polymer is derived from castor oil and is not formulated with intentionally added animal-derived components; nonetheless, final-device validation is mandatory because color concentrates, processing stabilisers, adhesives, and sterilisation residues can influence the final leachables profile.
| Endpoint | Standard | Device evaluation scope |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | All externally communicating devices |
| Irritation and skin sensitisation | ISO 10993-10 | Surface- and tissue-contacting devices |
| Acute systemic toxicity | USP <88> Class VI | Regulatory submission support for short-term contact |
| Ethylene oxide residuals | ISO 10993-7 | Post-sterilisation device release |
The MED designation changes supplier documentation more than base chemistry. Standard Rilsan BESNO grades are chemically similar but are not automatically supported by the same medical biological test data or change-notification provisions. Purchasing controls should verify the grade name on invoices and certificates to prevent substitution with industrial BESNO material. A supplier change-management agreement should specify notification for polymerisation-site changes, monomer-source changes, and formulation changes.
Ethylene oxide sterilisation is the most commonly selected route for Rilsan BESNO MED components because it operates below the material’s heat-deflection range and avoids radiation-induced oxidative yellowing. Following EtO processing, residual gas testing per ISO 10993-7 is a release requirement. Gamma irradiation at terminal doses of 25–40 kGy can color the material yellow and reduce tensile elongation; if gamma is required, the device manufacturer must establish a post-irradiation property window for impact and tensile behavior. Electron-beam irradiation can generate similar oxidative effects, particularly at high dose rates.
Chemical-contact boundaries are defined by the actual use environment. PA11 is generally resistant to saline solutions, aliphatic hydrocarbons, and many oils; however, strong mineral acids, phenolic solvents, and concentrated oxidising agents can attack the polymer and create stress-cracking. Chemical compatibility should be evaluated under ASTM D543 or ISO 22088 for environmental stress cracking, using the actual device geometry, sterilisation condition, and applied strain. Temperature accelerates fluid interactions: contact with a fluid at 37 °C may pose less risk than pressurised contact at 70 °C. Published data for a given drug formulation and PA11 grade is often limited, so extractables and leachables testing under the intended clinical contact conditions is required.
When comparing within the Arkema Rilsan PA11 family, BESNO MED is an unplasticised medical grade selected for components requiring stiffness, dimensional stability, and higher tensile modulus. BESNO P40 MED is a plasticised PA11 grade that offers lower flexural modulus and higher elongation at break, but at the expense of creep resistance under constant load. Processors switch from BESNO MED to BESNO P40 MED when thin-wall tubing or snap-fit designs require a more flexible response; the decision should be based on tensile modulus and strain-at-break data from ISO 527-1/-2, not on Shore hardness alone.
Compared with a typical unmodified PA12, Rilsan BESNO MED is not a drop-in replacement. The PA11 grade has a higher melting point near 189 °C, which increases heat-setting temperatures and may shorten cycle time but also raises the risk of thermal degradation if lines are set to PA12 barrel profiles. A representative PA12 grade has a melting point in the 175–180 °C range and lower density near 1.01 g/cm³; Rilsan BESNO MED is slightly denser at 1.04 g/cm³. Chemical-resistance profiles overlap but are not identical: PA11 is generally resistant to hydrocarbon greases, saline solutions, and many oils; immersion testing should be performed under ASTM D543 or ISO 22088 before substituting one material family for the other. For dynamic flexural fatigue in catheter shafts, the availability of medical documentation and monomer composition are often more important than a single tensile value, but the change in density, thermal profile, and moisture response must be revalidated in the finished device.
Typical device applications documented in technical literature for medical PA11 include extruded catheter shafts, multi-lumen tubing, luer and connector bodies, Y-sites, clips, and short-term instrument housings. In such applications the material is selected primarily for its balance of stiffness, toughness, chemical resistance, and sterilisation compatibility. For catheter shaft extrusion, lumen concentricity and kink resistance are design-dependent; performance testing must follow the applicable device standard, such as ISO 10555-1 for intravascular catheters. The presence of a MED designation does not by itself satisfy any device standard; it only provides a controlled starting resin for validation.
The material has operational boundaries. It is not intended for continuous exposure to strong mineral acids, phenolic solvents, or boiling water under pressure. Moisture above 0.10 wt% before processing causes hydrolysis and loss of mechanical performance. Regrind use in medical production should be validated by the device manufacturer; undocumented regrind can shift viscosity, create contamination, and invalidate biological test assumptions. If regrind is validated, the maximum fraction and thermal history must be controlled in the production record. No performance claim transfers automatically from dry-as-molded pellets to a sterilised finished device.
