| HS Code | 241456 |
| Product Name | CENTROPLAST CENTROMID 12 LE soft Polyamide 12 LE soft |
| Material | Low-extractable soft Polyamide 12 (PA12) |
| Color | Natural / translucent |
| Density | 1.01 g/cm³ |
| Shore Hardness | Shore D 55 |
| Tensile Strength | 35 MPa |
| Elongation At Break | 300% |
| Flexural Modulus | 600 MPa |
| Melting Point | 178 °C |
| Water Absorption At 24h | 0.30% |
| Sterilization Compatibility | EtO, steam, gamma, and e-beam |
| Biocompatibility | USP Class VI / ISO 10993 compliant |
| Extractables | Low-extractable grade |
As an accredited CENTROPLAST CENTROMID 12 LE soft Polyamide 12 LE soft factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | CENTROPLAST CENTROMID 12 LE soft is supplied as free-flowing granules in sealed 25 kg polyethylene-lined bags. |
| Container Loading (20′ FCL) | 20′ FCL loading of CENTROPLAST CENTROMID 12 LE soft polyamide: palletized bags, securely stowed, protected from moisture, weight optimized for safe transport. |
| Shipping | CENTROPLAST CENTROMID 12 LE soft Polyamide 12 is supplied as granules in sealed, moisture-proof bags, shipped in sturdy cartons or bulk containers. Avoid prolonged exposure to humidity and heat. Store in a cool, dry area. Not classified as hazardous under standard transport regulations. Handle with care to prevent bag damage. |
| Storage | Store in original, sealed packaging in a cool, dry, well-ventilated area away from direct sunlight, heat sources, and moisture. Keep the container tightly closed to prevent water absorption, which can affect material properties. Avoid exposure to strong oxidizers. Maintain stable temperatures below 50°C and use within the recommended shelf life. |
| Shelf Life | Store unopened in a cool, dry place away from sunlight. Shelf life is 2 years from date of manufacture. |
Coextrusion of CENTROPLAST CENTROMID 12 LE soft as the outer layer in multilayer automotive fuel vapor return lines requires verification of residual extractables before production release. The low-extraction designation is not a self-certifying property; it is checked against ISO 6427 using Soxhlet extraction on compression-moulded film with particle size below 0.5 mm. The material is dried in a desiccant dryer at 80 °C until moisture content is below 0.10% by weight, as measured by ISO 15512. Molten polyamide 12 is hydrolytically sensitive above 260 °C, so melt temperature is limited to 220 °C to 250 °C and residence time at temperature is kept below 10 min. Single-screw extrusion is performed on a barrier screw with an L/D ratio of 25:1 to 30:1, a grooved feed section, and vacuum devolatilisation at −0.08 MPa; the vent port is positioned after the compression zone to remove residual water and lactam monomers. The grade is coextruded as the outer jacket of a five-layer tube with a typical structure consisting of PA12 outer layer, adhesive tie layer, EVOH barrier layer, second tie layer, and conductive PA12 inner layer. The soft outer layer compensates for the stiffness of the barrier layer and provides impact resistance during clip attachment and stone impact; the inner conductive layer is included only when electrostatic dissipation is required by the fuel system specification. Finished fuel vapor return lines based on this architecture are tested according to DIN 73378 for burst pressure at 23 °C and 100 °C, for dimensional change after heat ageing at 125 °C for 72 h, and for low-temperature impact at −40 °C. Peel adhesion between the outer PA12 layer and the tie layer is most sensitive to melt viscosity mismatch at the die land; an apparent shear viscosity ratio at 100 s⁻¹ outside 1:1 to 1.5:1 produces delamination in corrugated sections. Published data for CENTROMID 12 LE soft in this exact five-layer configuration is limited, so production validation must be based on line trials rather than on transfer of data from other soft PA12 grades. The terminal product is an 8 mm to 10 mm outer-diameter fuel vapor return line with corrugated and smooth sections, assembled with quick connectors and rated for continuous fuel contact up to 60 °C. Outer layer wall thickness is normally 0.8 mm to 1.2 mm, depending on the bending radius specified by the vehicle packaging.
Pneumatic control lines used in automated handling cells are exposed to repeated bending at flexing radii between 40 mm and 80 mm while internal pressure remains at 0.8 MPa to 1.0 MPa. CENTROPLAST CENTROMID 12 LE soft is specified only after the compound has demonstrated that plasticizer migration into adjacent polyurethane seals is negligible; the test procedure is based on ISO 6427 total extractables and on gravimetric change of a reference polyurethane sheet after 72 h contact at 60 °C. The formulation must be free of monomeric plasticizers because fugitive plasticizer causes seal swelling and reduces fitting retention force below the minimum required by ISO 14743. Drying before extrusion is set at 80 °C for 4 h to 5 h in a closed-loop desiccant dryer, producing a pellet moisture content below 0.08%. The tube is extruded through a straight crosshead die with a vacuum sizing tank; outer diameter tolerance is held to ±0.05 mm and wall thickness tolerance to ±0.03 mm, because push-in fitting leakage rates increase when ovality exceeds 0.1 mm. Melt temperature is controlled at 225 °C to 235 °C, and the screw is a three-zone single-screw with an L/D of 25:1; a gear pump is inserted before the die to reduce pressure fluctuation to less than 0.1 MPa. In-line laser diameter gauges and ultrasonic wall measurement are used to reject sections outside the tolerance band. The terminal product is polyamide 12 tubing in outside diameters from 4 mm to 12 mm with wall thicknesses from 0.75 mm to 1.5 mm, coloured black or blue. Continuous flexural loading is limited not primarily by PA12 mechanical fatigue but by the oxidative induction time of the stabiliser package at the maximum ambient temperature of the cell, commonly 55 °C to 60 °C. When the tube is subjected to continuous flexing at 60 °C, published data for CENTROMID 12 LE soft is limited; therefore, replacement of a validated PA11 or PA12 grade should be preceded by pressure cycling tests at 1.0 MPa and 80 °C with the specific fitting body material.
Drag-chain power and control cables require an outer sheath that resists notch propagation while not stiffening at bending radii below 10 times the cable outer diameter. CENTROPLAST CENTROMID 12 LE soft is considered for this application because it does not require halogenated flame retardants to achieve standard cable flammability behaviour; decomposition gases are tested under IEC 60754-2 for pH and conductivity. Smoke density is evaluated by IEC 61034-2; the compound must not exceed the cable design specification for light transmittance. The sheath is applied by pressure extrusion at a melt temperature of 230 °C to 245 °C over a stranded conductor assembly, using a crosshead die with a compression ratio between 1.8:1 and 2.2:1 to prevent melt fracture at line speeds above 25 m/min. Pre-drying at 75 °C for 5 h is mandatory when storage relative humidity exceeds 60%; moisture above 0.10% results in surface bubbling and pinholes that are not visible until the cable is flexed. The extruder is a 30:1 L/D grooved-barrel machine with a vacuum vent at −0.06 MPa; a melt pump is used only when wall thickness below 0.5 mm is required. Terminal products are highly flexible cables with conductor cross-sections from 0.5 mm² to 4 mm², used in linear motion systems, gantry robots, and machine tool energy chains. Outer sheath wall thickness is typically 0.6 mm to 1.0 mm, and cable outer diameter is kept below 12 mm to meet minimum bending radius constraints. A key process conflict is that low melt viscosity improves line speed but reduces concentricity; eccentricity above 8% causes premature jacket cracking after 1 million flexural cycles. Published data for CENTROMID 12 LE soft under continuous drag-chain flexing is limited; therefore, qualification requires bend cycling tests on the finished cable according to the cable design specification, not raw-material tensile data alone.
Replacement of a thermoplastic polyurethane jacket with CENTROPLAST CENTROMID 12 LE soft in a medical catheter shaft is initiated only after a full leachable and cytotoxicity screen, because low extractables in a raw-material certificate do not automatically satisfy biological evaluation requirements. The grade is dried at 70 °C for 6 h to a moisture content below 0.10% before cleanroom microextrusion; a desiccant dryer with a −40 °C dew point is used rather than a hot-air oven. Extrusion is performed on a microextruder with screw diameter 12 mm to 20 mm and L/D ratio 16:1 to 24:1, fitted with a melt filter pack rated at 15 µm; barrel temperatures are ramped from 190 °C at the feed throat to 240 °C at the die. Melt pressure is kept below 35 MPa to avoid shear-induced gels and die drool that generate particulate defects on the jacket surface. The soft PA12 is coextruded over a braided or coiled wire core at line speeds between 10 m/min and 30 m/min, depending on outer diameter and wall thickness. Finished catheter jackets are tested under ISO 10993-1, ISO 10993-5, and ISO 10993-10; for devices with blood contact, USP <88> Class VI or ISO 10993-11 may be required depending on the regulatory pathway. The formulation constraint is the exclusion of free amine-based heat stabilisers when ethylene oxide sterilisation is planned, because residual amines can contribute to positive cytotoxic response and to ethylene oxide residues beyond the limits of ISO 10993-7. Terminal product is a braided introducer catheter jacket with outer diameter 2.0 mm to 3.5 mm and wall thickness 0.15 mm to 0.30 mm. Gamma sterilisation at 25 kGy causes measurable discolouration and an increase in flexural modulus; published data for this specific grade at 50 kGy is limited, so electron-beam or ethylene oxide sterilisation is preferred when colour stability and retained flexibility are critical. Post-sterilisation tensile testing according to ISO 527-1 and ISO 527-2 after accelerated ageing at 40 °C for 90 days is recommended to establish shelf life.
| Application segment | Primary standard or test method | Critical parameter |
|---|---|---|
| Automotive fuel vapor return lines | DIN 73378, ISO 6427, ISO 15512 | Residual moisture <0.10%; melt temperature 220–250 °C |
| Pneumatic control lines | ISO 14743, ISO 6427 | Outer diameter tolerance ±0.05 mm; extractables below line specification |
| Cable sheathing in drag chains | IEC 60754-2, IEC 61034-2 | Gas corrosivity pH ≥ 4.3, conductivity ≤ 10 µS/mm |
| Medical catheter jackets | ISO 10993-1, ISO 10993-5, USP <88> | Cytotoxicity grade 0 or 1; leachable profile validated |
| Monofilament filter mesh | EU 10/2011, FDA 21 CFR 177.1500 | Overall migration ≤ 10 mg/dm² for food contact |
| Offshore umbilical jackets | ISO 62, ISO 13628-5, ISO 974 | Water absorption after 24 h <0.25%; brittleness temperature below −40 °C |
Quenching of PA12 monofilament in water at 40 °C to 60 °C followed by two-stage drawing at ratios 3.5:1 to 4.5:1 yields oriented filaments for filter fabrics and paper machine clothing. CENTROPLAST CENTROMID 12 LE soft is dry-blended before extrusion with a hydrolysis stabiliser masterbatch at 2 wt% to 3 wt%; the let-down ratio is fixed only after sieve life testing in a pilot paper machine wet end, because excessive stabiliser concentrates can migrate to the monofilament surface and alter fabric dewatering behaviour. The polymer is extruded on a 30:1 L/D single-screw extruder with a gear pump, screen pack filtration at 40 µm, and die pressure maintained between 12 MPa and 16 MPa. Spinneret hole diameters range from 0.3 mm to 0.8 mm; the melt strand is quenched in a two-stage water bath with the first godet speed controlled at 15 m/min to 20 m/min. Drawing takes place in a hot-air oven at 150 °C, followed by relaxation at 120 °C for 8 s to 12 s to reduce residual stress and improve knot strength. Residual moisture before drawing is held below 0.05% to prevent bubbles at the spinneret. Terminal product is a monofilament filter cloth with open area between 35% and 45%, applied in food processing and paper machine dewatering. If food contact is claimed, the finished fabric must be tested under EU 10/2011 for overall migration in the intended simulant, and under FDA 21 CFR 177.1500 where applicable; the raw-material certificate alone does not clear the finished article. In paper machine wet-end service, filament fracture after extended exposure to hypochlorite cleaning solutions is more likely than base hydrolysis of PA12; published data for CENTROMID 12 LE soft under these cleaning regimes is limited.
Subsea hydraulic control umbilical jackets require low water absorption, resistance to hydrolysis in hot water, and flexibility at installation temperatures down to −20 °C. CENTROPLAST CENTROMID 12 LE soft is used as jacketing over steel or elastomeric tubes only after verification of water absorption below 0.25% after 24 h immersion according to ISO 62; published data for this specific grade is limited, so values must be confirmed on injection-moulded plaques, not pellets. The processing risk is post-extrusion shrinkage on long continuous runs; extruding at a melt temperature of 235 °C to 245 °C and maintaining a vacuum sizing tank water temperature of 20 °C to 30 °C reduces axial residual stress. The jacket is applied by pressure extrusion at wall thickness 0.8 mm to 1.2 mm on cores with outside diameter 6 mm to 18 mm. A single-screw extruder with an L/D of 25:1 to 30:1 and a barrier screw is used; pre-drying at 80 °C for 5 h is required to reach moisture below 0.10%. The compound should not be processed with amine-based additives that can react with seawater-exposed copper or zinc in connector components. Terminal product is a jacketed control umbilical for subsea production systems designed to ISO 13628-5. Hydrolysis resistance is evaluated by hot-water ageing at 95 °C for 500 h, with tensile strength retention measured according to ISO 527-2; the jacket must retain at least 50% of original elongation at break to survive installation and service. Low-temperature impact is assessed by ISO 974 brittleness temperature; values below −40 °C are specified for most North Sea installations. Published data for CENTROMID 12 LE soft under high-pressure autoclave conditions is limited, so qualification must be performed on the complete umbilical assembly.
| Application segment | Drying temperature | Target moisture | Melt temperature | Key processing constraint |
|---|---|---|---|---|
| Multilayer fuel vapor line outer layer | 80 °C | <0.10% | 220–250 °C | Viscosity match with tie layer at 100 s⁻¹ |
| Pneumatic tube | 80 °C | <0.08% | 225–235 °C | Ovality <0.1 mm; gear pump required |
| Cable sheath | 75 °C | <0.10% | 230–245 °C | Concentricity deviation <8% at line speed |
| Medical catheter jacket | 70 °C | <0.10% | 190–240 °C | Melt pressure <35 MPa; filtration 15 µm |
| Monofilament | 80 °C | <0.05% | 230–245 °C | Draw ratio 3.5:1–4.5:1; relaxation 120 °C |
| Offshore jacket | 80 °C | <0.10% | 235–245 °C | Vacuum sizing water 20–30 °C to limit shrinkage |
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CENTROPLAST CENTROMID 12 LE soft is a plasticised polyamide 12 compound supplied as cylindrical granules for flexible extrusion and injection-moulded components. The LE designation indicates a low-extractable formulation strategy, while the soft grade identifies reduced flexural stiffness and increased elongation compared with unmodified PA12. The base polymer is produced from laurolactam; flexibility is achieved by a proprietary modification system that lowers stiffness without changing the fundamental polyamide 12 backbone. Product-specific values are controlled by the CENTROPLAST technical datasheet and lot certificate. The class-level data presented below represent the typical envelope for plasticised PA12 soft extrusion compounds, not a contractual specification, because public lot-specific data for this exact designation remain limited.
Typical physical parameters for the class include density under ISO 1183-1:2019 between 1.01 g/cm³ and 1.04 g/cm³, Shore D hardness under ISO 868 between 55 and 70, and tensile modulus under ISO 527-2:2012 below 800 MPa. Nominal strain at break is generally above 250%. Unmodified PA12 reference grades exhibit Shore D hardness above 75 and tensile modulus between 1400 MPa and 1800 MPa. The soft grade therefore addresses components that require tight-radius bending, snap-fit insertion, or vibration damping where rigid PA12 would kink or fail by flexural fatigue. Published data for this specific configuration is limited; the manufacturer’s lot certificate remains the controlling reference.
Relative to unmodified PA12, the LE soft grade lowers flexural modulus and Shore D hardness while retaining the low equilibrium moisture uptake of the polyamide 12 backbone. At 23 °C and 50% RH, PA12 typically absorbs less than 1.0% moisture under ISO 62:2008, whereas PA6 and PA66 absorb 2.5% to 3.0% under the same conditions. This lower moisture uptake reduces swelling and dimensional change in humid pneumatic circuits and fuel vapour lines.
Compared with PA11, PA12 offers lower density and lower moisture uptake, but the melting peak determined by differential scanning calorimetry under ISO 11357-3:2018 is slightly lower, commonly in the range 170 °C to 180 °C for PA12 versus 185 °C to 195 °C for PA11. The practical consequence is that PA11 may provide a marginally higher continuous-use temperature, while PA12 soft provides lower mass and better dimensional stability in wet environments. The choice is therefore governed by the upper service temperature and extraction limits of the target assembly.
| Property | Test method | Plasticised PA12 soft class envelope | Unmodified PA12 reference |
|---|---|---|---|
| Density | ISO 1183-1:2019 | 1.01–1.04 g/cm³ | 1.01 g/cm³ |
| Shore D hardness | ISO 868 | 55–70 | 75–80 |
| Tensile modulus | ISO 527-2:2012 | 350–800 MPa | 1400–1800 MPa |
| Flexural modulus | ISO 178:2019 | 300–600 MPa | 1200–1500 MPa |
| Nominal strain at break | ISO 527-2:2012 | >250% | >200% |
| Melt volume-flow rate at 235 °C/5 kg | ISO 1133-1:2022 | 8–20 cm³/10 min | 5–15 cm³/10 min |
| Melting peak | ISO 11357-3:2018 | 170–180 °C | 175–180 °C |
Flexible PA12 compounds generally retain notched impact at low temperatures. ISO 179-1/1eA values at -30 °C may remain above 10 kJ/m² for plasticised grades, while unplasticised PA12 may drop below 8 kJ/m². For unsupported tube bending, the soft grade is less prone to stress whitening and kinking; however, plasticiser migration over time can increase stiffness at elevated temperatures. Accelerated ageing under ISO 188:2011 at 100 °C for 168 h is commonly used to screen for hardness drift. If hardness increases by more than 5 Shore D points after ageing, the application should be reviewed for plasticiser loss under service conditions.
Migration kinetics are diffusion-controlled and follow Fickian behaviour in thin-walled sections; the diffusion coefficient increases with temperature and with the solubility parameter difference between plasticiser and contact fluid. In fuel contact, the plasticiser can be extracted by aromatic hydrocarbons, increasing hardness and reducing flexibility. Extraction resistance is assessed by immersion under ASTM D471 reference fluids, but exact fluid-specific data for CENTROMID 12 LE soft must be obtained from the manufacturer. The LE designation indicates that the formulation is intended to reduce the total extractable fraction, but it does not eliminate swelling in aggressive solvents.
In corrugated tube and pneumatic line extrusion, the material is dried to a residual moisture content below 0.1% by weight in a desiccant dryer with a dew point of -30 °C or lower. Drying at 80 °C for 4 h to 6 h is typical; drying above 90 °C can cause plasticizer exudation, pellet surface tack, and feed-throat bridging. Processing on a single-screw extruder with a 25:1 to 30:1 L/D barrier screw and screen packs from 60 µm to 120 µm is used on production lines; a gear pump reduces pressure oscillation in thin-wall tube dies.
Melt temperature at the die entry should be maintained between 210 °C and 230 °C. Residence time above 240 °C is minimised because oxidative chain scission and volatile additive loss can shift viscosity and increase extractables. Barrel temperature profiling from 180 °C at the feed throat to 220 °C at the metering section is common. At output rates above 80 kg/h, screw speed reductions or grooved-barrel cooling may be required to control shear heating. Shark-skin surface defects at the die exit indicate excessive shear stress; line speed reduction or die-land modification is preferred over increasing melt temperature. Melt-pressure variation across a 60 µm screen pack should remain below 5 bar; larger pressure swings indicate screen blinding from degraded polymer gels or additive agglomerates.
For injection-moulded fittings and quick-connect bodies, a low-compression screw of 2.5:1 to 3.0:1 with short back pressure is used. Melt temperature of 220 °C to 240 °C, mould temperature 60 °C to 90 °C, and holding pressure 40 MPa to 70 MPa are typical class-level settings. The soft grade fills thin walls at lower injection pressure than unmodified PA12, but gates must be sized for the higher elongation and lower modulus to avoid jetting and flow marks. Vent depths of 0.01 mm to 0.02 mm are used to prevent gas burns without flash.
The main process conflict is between moisture control and plasticizer bleed. Insufficient drying leads to hydrolytic degradation at melt temperatures above 220 °C, visible as viscosity reduction, gas bubbles, and reduced tube burst strength. Overdrying or excessive barrel temperatures can extract the softening additive, producing a harder skin on pellets and increasing Shore D by 5 to 8 points in extruded wall sections. Closed-loop hopper drying with dew-point monitoring and melt-pressure logging is therefore specified for stable production.
During extrusion, molecular orientation in the machine direction increases tensile strength along the tube axis but reduces hoop strength unless the die is designed for balanced drawdown. For PA12 soft tubing, drawdown ratios are typically limited to 1.5:1 to 2.5:1 to preserve hoop strength and elongation. Higher drawdown can produce anisotropic shrinkage and poor fitting retention. In multilayer tube constructions, PA12 soft is often coextruded with EVOH barrier layers or PA6 inner layers; tie-layer selection must account for maleic anhydride grafted polyolefins to maintain interlayer adhesion.
Regrind from sprue, start-up purge, and edge trim can be added at up to 20% in many tube extrusion operations, but the exact ratio must be validated for burst strength and extractables. Multiple heat histories increase gel formation and can raise the extractable fraction. Closed-loop reprocessing of post-industrial scrap is preferred over post-consumer recyclate for applications in pressure-rated tubing. Burst strength validation should follow ISO 1167 or ASTM D1598 on finished tube specimens, not on injection-moulded plaques.
Laser welding of PA12 soft to rigid PA12 is possible where the laser-transparent upper layer and laser-absorbing lower layer have melt-temperature overlap. Because the soft grade contains plasticiser, laser transmission may be reduced by additive haze; transmission at 940 nm should be checked on natural or black specimens. Ultrasonic welding requires amplitude and force adjustment for the lower modulus; high amplitude can melt the soft surface before the joint interface is heated. Adhesive bonding may require surface pretreatment by plasma or corona because the low surface energy of PA12 can limit bond strength; lap-shear testing under ISO 4587 is used to compare adhesive systems.
After injection moulding, PA parts are often conditioned to equilibrium moisture to increase impact toughness. For PA12 soft, conditioning is less critical than for PA6 or PA66 because moisture uptake is low; however, if parts are conditioned at 70 °C and 62% RH, dimensions may increase by 0.1% to 0.3%. Dimensional tolerances should be validated after conditioning to the expected service humidity. Mould shrinkage for soft PA12 grades is generally in the range 0.5% to 1.0% depending on wall thickness and gate orientation, measured after 24 h at 23 °C. Post-mould shrinkage at elevated temperature may add 0.2% to 0.5%. Packing pressure should be held until gate freeze; gate freeze time is typically longer than for unmodified PA12 because the lower modulus delays solidification under pressure.
In comparison with polyether block amide, plasticised PA12 soft generally retains higher polyamide chemical resistance and lower moisture uptake, but polyether block amide provides greater elastic recovery and lower tensile set after repeated elongation. The choice in flexible conduit and cable protection therefore depends on whether chemical exposure or cyclic flexural deformation is the limiting requirement. For oily environments with repeated bending, PA12 soft may be preferred; for high elastic recovery at high strain, polyether block amide grades are typically specified.
Compared with thermoplastic polyurethane, PA12 soft exhibits lower density by roughly 0.15 g/cm³ to 0.20 g/cm³ and better resistance to hydrolysis in hot-wet environments, but thermoplastic polyurethane offers higher abrasion resistance and tear strength. Abrasion resistance should be quantified under ISO 4649 or ISO 5470-1; published class-level comparison data for this exact PA12 soft grade remain limited. For cable sheathing, flexibility at low temperature and chemical resistance may outweigh abrasion; for pneumatic hose liners, thermoplastic polyurethane may be used as an outer jacket over a PA12 soft inner layer.
Low-extractable behaviour is relevant for fuel vapour tubing, pneumatic lines, and air-conditioning hose connectors. Extractable-matter testing under ISO 6427:2013 is used to measure organic extractables after solvent exposure. For fuel-contact applications, the material is often evaluated against SAE J2260 for non-metallic fuel system tubing or SAE J844 for air brake tubing. When these standards are invoked, the finished tube assembly must be tested rather than the raw compound alone, because extrusion orientation, heat history, and fitting insertion modify burst strength and permeation behaviour.
Unopened bags should be stored in dry conditions below 30 °C and protected from direct sunlight. If bags are opened in high-humidity environments above 60% RH, the material should be re-dried before processing. Moisture regain in plasticised PA12 can be more rapid than in unmodified PA12 because the plasticiser can increase free volume; hopper residence time at high humidity should therefore be limited. A desiccant-bed dryer with -40 °C dew point is preferred over hot-air ovens, which may cause surface oxidation of granules during prolonged drying.
For cable sheathing, volume resistivity and dielectric strength may be relevant. PA12 soft grades typically show volume resistivity above 10^12 Ω·cm after conditioning at 23 °C and 50% RH, measured under IEC 62631-3-1. This value is humidity-dependent; immersion reduces resistivity. The soft grade may be formulated with carbon black for UV protection, which affects surface resistivity and cannot be assumed insulating unless specified.
Long-term thermal ageing of PA12 soft is limited by oxidative degradation and plasticizer volatilisation. Continuous-use temperatures above 90 °C may increase hardness and reduce elongation after several thousand hours. Thermal endurance testing under ISO 2578 or IEC 60216 is required to establish a temperature index for a specific property endpoint. Published data for this exact CENTROMID 12 LE soft configuration is limited; therefore, service-temperature claims should be derived from lot-specific ageing studies, not from generic PA12 thermal data.
The base PA12 chemistry may be evaluated under FDA 21 CFR 177.1500 for food-contact use and EU 10/2011 for plastic food-contact materials. Such compliance is concentration- and migration-limited and must be confirmed for the specific CENTROMID 12 LE soft formulation and the final article geometry. For medical device components, cytotoxicity testing under ISO 10993-5 and sensitisation or irritation testing under ISO 10993-10 may be required; the manufacturer should provide a statement of compliance for the exact lot.
Chemical resistance should be assessed under ISO 175:2010 or ASTM D543 with the actual process fluid at the maximum service temperature. Swelling beyond 3% mass uptake or 2% dimensional change is generally considered a risk for load-bearing components, though specific limits depend on design tolerance. Flammability is typically assessed under UL 94; unmodified PA12 is usually classed HB, and a soft grade is unlikely to achieve higher ratings without flame-retardant modification. For applications requiring V-2 or better, a specifically flame-retarded PA12 grade should be selected, not the LE soft general-purpose material.
| Requirement | Standard or regulation | Typical evaluation scope |
|---|---|---|
| REACH SVHC declaration | EC 1907/2006 | Article 33 communication for substances on the candidate list |
| RoHS restricted substances | 2011/65/EU as amended by 2015/863 | Heavy metals, brominated flame retardants, specified phthalates |
| Food-contact base polymer | FDA 21 CFR 177.1500, EU 10/2011 | Migration-limited; article geometry must be tested |
| Medical device biocompatibility | ISO 10993-5, ISO 10993-10 | Cytotoxicity, sensitisation, irritation as applicable |
| Extractable matter | ISO 6427:2013 | Organic extractable fraction after solvent exposure |
| Chemical resistance | ISO 175:2010, ASTM D543 | Mass and dimensional change in process fluids |