| HS Code | 789653 |
| Density | 1.46 g/cm³ |
| Water Absorption 24 Hr | 0.20 % |
| Melt Flow Rate 260 C 2 16 Kg | 15 g/10 min |
| Tensile Modulus | 2400 MPa |
| Tensile Stress At Yield | 32 MPa |
| Tensile Strain At Break | 40 % |
| Flexural Modulus | 2200 MPa |
| Charpy Impact Notched | 4.0 kJ/m² |
| Izod Impact Notched | 4.0 kJ/m² |
| Heat Deflection Temperature 0 45 Mpa | 120 °C |
| Heat Deflection Temperature 1 8 Mpa | 55 °C |
| Melting Temperature Dsc | 178 °C |
As an accredited Avient Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 (Nylon 12) factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Supplied as grey polyamide 12 pellets in sealed, moisture-resistant packaging. Quantity: 25 kg per bag. |
| Container Loading (20′ FCL) | 20-foot full container load of Avient Trilliant HC HC6200-5002 XR Grey Polyamide 12 pellets, packed and secured for transport. |
| Shipping | Avient Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 ships as dry pellets in sealed moisture-barrier bags or drums, palletized for safe transport. Store in a cool, dry area away from direct sunlight and humidity. No special hazard classification, but avoid dust inhalation and keep packaging intact during handling. |
| Storage | Store in a cool, dry, well-ventilated area away from direct sunlight, heat sources, and ignition. Keep the original container tightly sealed to prevent moisture absorption, which can degrade polyamide 12. Avoid contact with strong oxidizers. Maintain moderate room temperature and low humidity to preserve material properties and ensure safe handling. |
| Shelf Life | Shelf life is typically 2 years when stored sealed, cool, and dry, away from moisture and sunlight. |
Single-lumen and braided catheter shafts in the 3–8 French diameter range are extruded from Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 without supplemental radiopaque masterbatch; the as-supplied formulation is metered at 100 wt% into the main feed throat of a 24:1 to 30:1 L/D single-screw extruder, while in two-layer configurations the XR grade is restricted to the outer jacket at 25–40 wt% of total wall thickness and coextruded with an unfilled polyamide 12 or polyether block amide liner. Drying is mandatory to <0.10 wt% moisture before melt processing; residual moisture above 0.15 wt% generates hydrolytic degradation and surface splay on the catheter outside diameter. The barrel zone set points are profiled from 210 °C to 230 °C, with screw compression ratio 2.5:1 to 3.0:1 and a 200/400/200 mesh breaker plate stack to disperse the radiopaque filler while limiting melt temperature overshoot. A PTFE-coated die land is specified because the radiopaque filler increases die lip wear during continuous runs, and the breaker plate stack is inspected after each 8 h production block for filler agglomerates. Vacuum sizing is controlled to ±0.025 mm concentricity before tip forming, thermal welding, or cyanoacrylate bonding after surface activation. Compliance is evaluated under ISO 10993-1:2018 Clause 4.1 biological evaluation planning, ISO 10993-5:2009 Clause 5.2 quantitative cytotoxicity, ISO 10993-10:2021 Clause 6.2 sensitization, and USP <88> Class VI injection and implantation; manufacturing is executed under ISO 13485:2016 Clause 7.5.1 production and service provision and FDA 21 CFR Part 820 design controls. Terminal finished product types include diagnostic catheters, introducer sheaths, guiding catheter shafts, and peripheral intervention delivery system shafts.
Fluid management manifolds, stopcock bodies, and Y-connectors are injection molded from Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 with a formulation addition ratio of 100 wt% as-supplied for patient-contacting fluid paths; for non-fluid-path structural housings, validated post-industrial regrind from the same grade may be added up to 20 wt% only after cytotoxic revalidation under ISO 10993-5:2009. The radiopaque filler raises melt viscosity relative to unfilled PA12, so hot runner manifold temperatures are set between 250 °C and 270 °C while nozzle melt temperature is maintained at 230–250 °C. Mold temperature is controlled at 80–100 °C, and a short-shot protocol is executed at process validation to map gate freeze-off in thin-walled 0.5–1.0 mm sections; published data for this specific XR configuration is limited, so process capability is established with 80–120 t hydraulic or servo-electric injection molding machines using general-purpose screws of 20:1 to 22:1 L/D and reduced-clearance check rings to prevent filler migration. A valve-gated hot runner with 4 drops is used on multi-cavity stopcock molds, and melt cushion is held within ±0.5 mm to avoid cavitation and gate blush. Compliance includes ISO 80369-7:2016 Clause 4.1 small-bore connector geometry, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, USP <88> Class VI, and ISO 13485:2016. Terminal products are stopcock manifolds, Y-connectors, rotary luer adapters, and cardiology manifold sets.
Surgical instrument handles, laparoscopic device bodies, and reusable handpiece housings are molded from Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 with an addition ratio of 100 wt% as-supplied for external surfaces; for internal non-tissue-contacting ribs, up to 15 wt% same-grade post-industrial regrind is introduced only after steam sterilization and tensile creep revalidation. Components are injection molded on 120–180 t closed-loop machines with mold steel hardened to HRC 48–52 to withstand glass-free PA12 processing. Melt temperature is held at 230–250 °C, mold temperature at 90–110 °C, and hold pressure at 600–900 bar for 2–4 s per 1 mm wall thickness to minimize sink around metallic inserts. Post-molding conditioning in sealed moisture-barrier bags at 20–25 °C and 50–60% RH for 24–48 h stabilizes dimensions before ultrasonic welding or laser marking. Compliance includes ISO 17664-1:2021 Clause 5.2 processing instructions, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, and AAMI TIR12:2020 for reusable device reprocessing. Terminal finished product types include laparoscopic handles, electrosurgical handpieces, orthopedic power tool housings, and reusable biopsy instrument bodies.
| Application scenario | Primary compliance standards | Formulation addition ratio limit |
|---|---|---|
| Radiopaque catheter shaft / introducer | ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, USP <88> Class VI, ISO 13485:2016, FDA 21 CFR Part 820 | 100 wt% as-supplied; outer jacket 25–40 wt% of total wall thickness |
| Fluid management manifold / stopcock | ISO 80369-7:2016, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, USP <88> Class VI | 100 wt% fluid path; up to 20 wt% same-grade regrind non-fluid path |
| Surgical handpiece housing | ISO 17664-1:2021, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, AAMI TIR12:2020 | 100 wt% external; up to 15 wt% regrind internal |
| Wearable drug delivery chassis | ISO 11608-1:2022, IEC 60601-1:2005/A1:2012, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021 | 100 wt% overmold; up to 10 wt% regrind internal |
| Medical cable connector / strain relief | IEC 60601-1:2005/AMD1:2012, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, RoHS 2011/65/EU | 100 wt% connector body; up to 20 wt% regrind strain relief |
Where a wearable injector chassis must survive repeated snap-fit assembly and a 0.5 m drop onto hard flooring without cracking, Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 is overmolded onto a glass-filled polycarbonate or aluminum subframe at 100 wt% as-supplied for the external skin-contact housing; for non-cosmetic internal retention clips, up to 10 wt% same-grade post-industrial regrind is permitted only after ISO 10993-5:2009 revalidation. The first-shot substrate is preheated to 100–120 °C, and the PA12 overmold is injected at melt temperature 230–250 °C through a valve-gated hot runner with 8 drops; shot-to-shot cushion variation is maintained within ±0.3% by shut-off nozzles and screw recovery delay after metering, because the radiopaque filler raises wear at the nozzle tip and check ring. Overmolded bond strength is validated by pull-off testing on overmolded coupons according to ISO 527-2, and moisture is kept below 0.10 wt% before processing to avoid splay at the overmold interface. Compliance includes ISO 11608-1:2022 Clause 4.1 for needle-based injection systems, IEC 60601-1:2005/A1:2012 for electrical safety, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, and USP <88> Class VI. Terminal finished product types include wearable injector chassis, patch pump baseplates, autoinjector front sleeves, and retention clips.
Medical cable assembly connector bodies and strain reliefs are overmolded from Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 with an addition ratio of 100 wt% as-supplied for the connector body, because dilution would reduce radiopacity and alter melt viscosity; for strain relief boots that do not enter the sterile field, 20 wt% same-grade post-industrial regrind may be incorporated after peel adhesion and flex cycle testing. Cable assemblies are produced by overmolding PA12 onto wire bundles preheated to 90–110 °C; barrel temperatures are set at 230–250 °C, mold temperature at 80–100 °C, and injection speed is reduced to 5–10 mm/s until the melt front reaches the cable jacket to avoid conductor movement and jacket melt-through. Compliance includes IEC 60601-1:2005/AMD1:2012 Clause 8.8.3 mechanical strength for applied parts, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, and RoHS 2011/65/EU; terminal finished product types are patient monitor cable connectors, surgical instrument interface cables, imaging transducer cable shells, and endoscopy strain reliefs.
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The material introduced in this document is Avient Trilliant™ HC HC6200-5002 XR Grey Polyamide 12 (Nylon 12). The grade belongs to the Trilliant HC healthcare polymer portfolio and is supplied in grey. The XR suffix is associated with X-ray-visible or radiopaque capability in medical molding compounds; however, the exact radiopacifier package, filler loading, and resulting density shift are grade-specific and should be verified against the Avient technical data sheet. The product is intended for injection-molded medical device components where controlled formulation, healthcare documentation, lot traceability, and dimensional control after moisture exposure or sterilization are part of the specification. It is distinct from general-purpose industrial PA12 resins used in automotive tubing or cable jacketing and from non-XR medical nylon grades by the expected presence of a dense radiopaque additive.
Polyamide 12 is synthesized from laurolactam or ω-aminolauric acid. The repeating unit contains twelve carbon atoms between amide linkages, giving a lower amide density than PA6 or PA66. This structural feature limits equilibrium moisture uptake and reduces the crystalline melting point. Under ISO 62, unmodified PA12 reaches equilibrium water absorption of approximately 1.5% to 2.0% at 23°C in water; under the same test, unmodified PA66 can absorb 7.5% to 8.5%. The density of unmodified PA12 is approximately 1.01 g/cm³ to 1.03 g/cm³ under ISO 1183-1. A radiopacifier in the XR grade will raise density and shift mechanical properties relative to these unfilled baseline values.
Typical component formats for this material class include radiopaque instrument housings, catheter luers and hubs, surgical tool handles, dental device bodies, and microfluidic connectors. In these applications, X-ray-visible filler can provide radiographic contrast without a secondary metal marker, reducing assembly steps and eliminating marker detachment risk. Component viability depends on wall thickness, flow length, gate location, and the minimum radiopacity required by the clinical imaging system. Published data for this specific configuration is limited; radiopacity should be evaluated on molded plaques or prototype parts using the imaging method and energy range applicable to the finished device.
For dry-as-molded unmodified PA12, baseline mechanical values typically include tensile modulus of 1400 MPa to 1800 MPa, tensile yield stress of 40 MPa to 50 MPa, and nominal tensile strain at break above 200% when tested according to ISO 527-1/2. After conditioning under ISO 291 at 23°C and 50% relative humidity, modulus can decrease by 20% to 40% because absorbed water plasticizes the amorphous phase. For a filled X-ray-visible PA12, tensile elongation at break is generally lower than unfilled PA12 because dense radiopaque particles act as stress concentrators and reduce the load-bearing polymer fraction. The product-specific mechanical values for HC6200-5002 XR Grey must therefore be drawn from Avient’s datasheet rather than from unmodified PA12 family values.
An industrial PA12 grade may be released with a datasheet covering melt volume-flow rate, tensile properties, and moisture content. The Trilliant HC designation indicates a healthcare material management program with change control, raw-material qualification, and regulatory support. Depending on patient-contact duration and tissue type, this grade may be supported by biological evaluation summaries under ISO 10993-1:2018, cytotoxicity data reported under ISO 10993-5:2009, and irritation or sensitization data under ISO 10993-10:2021. Healthcare formulations may also be supported by statements against USP Class VI, FDA 21 CFR 177.1500, EU RoHS Directive 2011/65/EU, and REACH Regulation (EC) No 1907/2006. The precise statement set for HC6200-5002 XR Grey must be confirmed through Avient’s healthcare regulatory group, because a specific healthcare grade is released with individual test reports rather than a generic portfolio claim.
Table 2 lists standards commonly referenced for healthcare PA12 compounds. Applicability depends on the finished device classification and contact duration.
| Standard or regulation | Relevant scope |
|---|---|
| ISO 10993-1:2018 | Biological evaluation of medical devices |
| ISO 10993-5:2009 | Cytotoxicity testing |
| ISO 10993-10:2021 | Skin sensitization and irritation |
| ISO 10993-7:2008 | Ethylene oxide sterilization residuals |
| USP Class VI | Biological reactivity of plastic components |
| FDA 21 CFR 177.1500 | Nylon resins for repeated food contact |
| EU RoHS Directive 2011/65/EU | Restriction of hazardous substances |
| REACH Regulation (EC) No 1907/2006 | SVHC and authorization requirements |
Before melt processing, the resin should be dried to a residual moisture content below 0.10% by weight. A desiccant dryer operating at 80°C with a dew point of −30°C or lower is standard for polyamide 12; soak times are commonly 4 h to 8 h depending on initial pellet moisture. Injection molding can be performed on reciprocating screw machines with barrel temperatures from 230°C to 275°C and mold temperatures from 40°C to 80°C. A general-purpose nylon screw with an L/D ratio of at least 18:1 and a compression ratio between 2.5:1 and 3.0:1 is typical for unreinforced PA12. If the XR grade contains a mineral radiopacifier, melt viscosity and screw torque may increase; reducing screw speed and using a mildly reverse barrel temperature profile can limit shear heating and resin degradation.
The melt volume-flow rate of a polyamide 12 grade is reported under ISO 1133-1, but values are not comparable unless the temperature and load conditions are identical. Typical injection-molding PA12 grades may be measured at 235°C with 2.16 kg or at 275°C with 5 kg. Unfilled PA12 injection grades commonly fall between 10 cm³/10 min and 40 cm³/10 min; radiopaque filled grades can be lower because dense filler restricts melt flow. Direct melt-flow comparison between HC6200-5002 XR Grey and another PA12 grade should only be made using the same ISO method conditions reported on the Avient datasheet.
The melting point of PA12 at 175°C to 180°C is lower than the 260°C to 265°C typical of PA66 and the 220°C to 225°C typical of PA6. This lower melt temperature permits lower barrel set points and can reduce cooling time in thicker sections because less enthalpy must be removed. Mold temperature remains the key variable governing post-molding crystallinity and dimensional stability. At mold temperatures below 40°C, PA12 can freeze the skin before full packing, producing sink marks, weak weld lines, and jetting in thin-wall sections. Raising mold temperature to 60°C or 80°C improves surface replication and reduces shrinkage anisotropy but increases cycle time and may increase plate-out in filled grades.
Table 1 provides baseline unmodified PA12 ranges. The X-ray-visible grade will shift from these values because dense radiopaque fillers increase density and reduce elongation.
| Property | Test method | Typical range |
|---|---|---|
| Density | ISO 1183-1 | 1.01 g/cm³ to 1.03 g/cm³ |
| Melting temperature | ISO 11357-3 | 175°C to 180°C |
| Tensile modulus, dry | ISO 527-1/2 | 1400 MPa to 1800 MPa |
| Tensile yield stress, dry | ISO 527-1/2 | 40 MPa to 50 MPa |
| Nominal tensile strain at break, dry | ISO 527-1/2 | > 200% |
| Water absorption at saturation, 23°C | ISO 62 | 1.5% to 2.0% |
Two production-scale failure modes are observed with PA12 medical molding. First, if the resin is not dried below 0.10% moisture, melt pressure fluctuation and purge drool can develop because hydrolytic chain scission lowers molecular weight and produces volatile species. Second, in hot-runner systems with gate diameters of 0.8 mm or smaller, dense radiopaque fillers can accelerate gate wear and create gate-vestige inconsistency. Hardened gate inserts and periodic inspection of gate orifices are used to control these effects. These boundaries apply directly to HC6200-5002 XR Grey if the XR designation corresponds to a filled radiopaque compound as expected.
PA12 is specified for reusable devices that undergo steam autoclave cycles at 121°C to 134°C because its semi-crystalline structure retains shape above the glass-transition region. The lower water absorption of PA12 relative to PA6 and PA66 reduces the rate of hydrolytic chain scission in condensing steam, but hydrolysis is not eliminated. Repeated autoclave exposure can reduce tensile elongation and impact strength over the device lifetime. The effect may be more pronounced in a radiopaque filled grade because the polymer–filler interface can become a microcrack initiation site after repeated thermal and hydrolytic stress. Therefore, HC6200-5002 XR Grey should be qualified for the intended autoclave cycle count, load case, and part thickness rather than assumed equivalent to unfilled PA12.
Switching from PA6 or PA66 to PA12 changes the mechanical design in specific ways. Unmodified PA66 dry tensile modulus is approximately 3000 MPa to 3300 MPa under ISO 527-1/2, nearly double the 1400 MPa to 1800 MPa baseline of PA12. PA66 absorbs more moisture, and after conditioning at 50% relative humidity its modulus may fall to 1200 MPa to 1600 MPa, approaching the PA12 dry range. PA12 retains better low-temperature toughness than PA66 because lower amide density and reduced water plasticization limit embrittlement. However, PA12 is not a high-heat polymer; its heat deflection temperature under load is lower than that of PA66, and sustained load above 120°C is generally outside the design envelope for unmodified PA12. Glass-filled PA12 grades can exceed 7000 MPa tensile modulus under ISO 527-1/2, but their elongation is much lower than unfilled grades. HC6200-5002 XR Grey is expected to sit between unfilled and highly reinforced PA12 depending on radiopacifier loading; the product-specific stiffness, toughness, and X-ray opacity balance must be taken from Avient’s datasheet.
Chemical resistance of PA12 is broad for dilute acids, alkalis, greases, oils, and many cleaning agents, but concentrated mineral acids and strong polar solvents at elevated temperature can degrade the polymer. Compatibility with hospital disinfectants and cleaning agents should be evaluated under ISO 175 or ASTM D543 using molded specimens of HC6200-5002 XR Grey. Radiopaque filler can alter chemical resistance by increasing interfacial surface area and allowing solvent attack at the polymer–filler boundary. If the device is cleaned with quaternary ammonium compounds or hydrogen peroxide formulations, the concentration and dwell time must be included in the test to avoid stress-cracking artifacts.
For devices sterilized by gamma radiation, the oxidation response must be characterized on actual parts. Absorbed doses in the range of 25 kGy to 40 kGy may shift color and reduce tensile elongation after aging, especially in filled radiopaque grades because the polymer–filler interface increases radical formation sites. If ethylene oxide is used, residual ethylene oxide retention must be validated under ISO 10993-7:2008. For HC6200-5002 XR Grey, the preferred sterilization mode should be selected after testing on molded parts at the intended wall thickness, filler distribution, and clinical contact duration.