描述
VESTAMID Care ML94 is an unfilled, medium viscosity, heat stabilized polyamide 12 (PA12) resin from Evonik Operations GmbH, specifically developed for medical applications. It belongs to Evonik’s VESTAMID Care product line, which offers USP Class VI certified materials for the medical industry.
VESTAMID Care ML94 is resistant to body fluids and toxicologically safe. It is processed by injection molding, offering excellent processability and colorability. The material provides a balanced combination of flexibility, toughness, and dimensional stability, making it suitable for a wide range of medical device components.
Typical application areas for VESTAMID Care ML grades include catheters, housing parts, monitoring and imaging devices, and durable medical equipment.
This grade is developed for medical technology applications, with biocompatibility tested following ISO 10993-1 recommendations for surface medical devices with up to 30 days body contact. The material fulfills the requirements of USP <88> Class VI and has been tested by independent, certified laboratories.
For more VESTAMID grades and technical information, please visit our PA12/Polyamide 12 product page.
Key Features of VESTAMID Care ML94
| # | Feature | Benefit |
|---|---|---|
| 1 | Unfilled / Medium Viscosity | Balanced flow and melt strength for reliable injection molding |
| 2 | Heat Stabilized | Maintains properties at elevated temperatures |
| 3 | USP Class VI Compliant | Meets highest biocompatibility standards for medical applications |
| 4 | ISO 10993 Compliant | Tested for cytotoxicity, sensitization, irritation, and acute systemic toxicity |
| 5 | Up to 30 Days Body Contact | Approved for surface medical devices with up to 30 days body contact |
| 6 | High Flexibility & Elasticity | Excellent flexibility for catheters, tubing, and flexible components |
| 7 | Good Rebound Properties | Resilient and durable in demanding applications |
| 8 | High Impact Resistance | Excellent toughness and durability |
| 9 | High Toughness | Tough and resilient performance |
| 10 | High Abrasion Resistance | Excellent wear resistance for long-lasting components |
| 11 | Low Sliding Friction | Good sliding properties for moving parts |
| 12 | High Chemical Resistance | Resistant to chemicals and body fluids |
| 13 | High Dimensional Stability | Excellent dimensional stability for precision components |
| 14 | Gamma and EtO Sterilizable | Compatible with conventional sterilization methods |
| 15 | Plasticizer-Free | No plasticizer migration concerns for medical applications |
| 16 | Easy Processability & Colorability | Suitable for injection molding; can be easily colored |
| 17 | High Bursting Strength | Flexible and reliable performance |
Biocompatibility & Regulatory Compliance
VESTAMID Care ML94 has undergone comprehensive biocompatibility testing to ensure safety for medical applications:
| Standard | Test Description |
|---|---|
| USP Class VI | Acute Systemic Toxicity, Intracutaneous Reactivity, Muscle Implantation |
| ISO 10993-5 | Cytotoxicity |
| ISO 10993-10 | Sensitization (Maximization test according to Magnusson and Kligman) |
| ISO 10993-10 | Irritation (Intracutaneous Reactivity) |
| ISO 10993-11 | Acute Systemic Toxicity |
| ASTM F756-08 | Hemocompatibility |
VESTAMID Care ML94 fulfills the requirements of USP Class VI and ISO 10993 standards for medical applications with up to 30 days body contact.
Typical Applications for VESTAMID Care ML94
| Industry | Typical Components & Considerations |
|---|---|
| Catheters | Medical catheters and tubing – utilizing biocompatibility, flexibility, and high bursting strength |
| Medical Tubing & Hoses | Flexible tubing and hoses – utilizing high flexibility, rebound properties, and chemical resistance |
| Encapsulation | Encapsulant for electronic components in medical devices |
| Medical Device Housings | Housing parts for monitoring and imaging devices – utilizing dimensional stability and impact resistance |
| Monitoring & Imaging Devices | Components for monitoring and imaging equipment – utilizing chemical resistance and durability |
| Durable Medical Equipment | Components for durable medical equipment – utilizing toughness and chemical resistance |
Typical Properties of VESTAMID Care ML94
| Property | Value | Test Method |
|---|---|---|
| Physical | ||
| Density (23°C) | 1.01 g/cm³ | ISO 1183 |
| Water Absorption (Saturation, 23°C) | ~1.5% | Sim. to ISO 62 |
| Moisture Absorption (23°C, 50% RH) | 0.80% | Sim. to ISO 62 |
| Molding Shrinkage – Parallel | 0.85% | ISO 294-4, 2577 |
| Molding Shrinkage – Transverse | 1.2% | ISO 294-4, 2577 |
| Melt Volume Rate (MVR) | 110 cm³/10 min (275°C/5 kg) | ISO 1133 |
| Mechanical | ||
| Tensile Modulus | 1,350 – 1,440 MPa | ISO 527 |
| Tensile Stress at Yield | 45.0 MPa | ISO 527 |
| Tensile Strain at Yield | 5.0% | ISO 527 |
| Nominal Tensile Strain at Break | >50% | ISO 527 |
| Impact | ||
| Charpy Notched Impact (23°C) | Complete Break | ISO 179/1eA |
| Charpy Notched Impact (-30°C) | Complete Break | ISO 179/1eA |
| Thermal | ||
| Melting Temperature | 178°C | ISO 11357 |
| Glass Transition Temperature | 45°C | ISO 11357 |
| HDT @ 1.80 MPa | 50°C | ISO 75-1/-2 |
| HDT @ 0.45 MPa | 120°C | ISO 75-1/-2 |
| Vicat Softening Temperature (Method A) | 170°C | ISO 306 |
| Vicat Softening Temperature (Method B) | 140°C | ISO 306 |
| Flammability | ||
| Flammability (1.6mm / 3.2mm) | HB | IEC 60695-11-10 |
Important Notes on Typical Data
📌 Values are typical – The data listed above is sourced from manufacturer data sheets for reference only and does not constitute binding product specifications for VESTAMID Care ML94.
📌 Batch variations – Batch-to-batch deviations may exist. For critical applications, validate performance with batch-specific COA certificates.
📌 Final performance – Actual performance depends on processing conditions and part design. Refer to ISO testing standards for detailed methodology.
📌 Authoritative reference – The manufacturer’s official TDS shall serve as the definitive technical reference for VESTAMID Care ML94. Request the latest official TDS from our sales team.
📌 Regulatory Compliance – For medical applications, always verify current regulatory certifications (USP Class VI, ISO 10993) remain valid for your specific application and region.
Processing Guidelines for VESTAMID Care ML94
| Step | Process |
|---|---|
| Processing Methods | Injection Molding |
| Drying Recommended | Yes |
| Drying Temperature | 80 – 90°C |
| Drying Time | 4 – 6 hours |
| Suggested Max Moisture | ≤ 0.10% |
| Melt Temperature | 210 – 270°C |
| Optimum Melt Temperature | 230 – 250°C |
| Mold Temperature | 40 – 80°C |
| Injection Pressure | Medium to high |
| Hold Pressure | 30 – 70 MPa |
| Injection Velocity | Medium |
| Storage | Store in original, sealed packaging in a cool, dry place away from direct sunlight |
Critical Processing Warnings for VESTAMID Care ML94
⚠️ Drying Requirement – VESTAMID Care ML94 requires drying prior to processing to prevent hydrolytic degradation. The recommended drying conditions are 80–90°C for 4–6 hours.
⚠️ Moisture Control – Maximum residual moisture content should be ≤ 0.10%. Proper drying is essential to prevent void formation and ensure optimal part quality.
⚠️ Melt Temperature – The recommended melt temperature range is 210–270°C, with an optimum of 230–250°C. Avoid exceeding 270°C to prevent material degradation.
⚠️ Mold Temperature – A mold temperature range of 40–80°C is recommended. Higher mold temperatures promote higher crystallinity and better dimensional stability.
⚠️ Medical Grade – The “Care” designation indicates this grade is specifically developed for medical applications. For medical applications, ensure all processing and handling procedures maintain material purity and compliance.
⚠️ Medium Viscosity – This grade features medium viscosity, providing a balance between flow and melt strength. Adjust processing parameters accordingly for optimal results.
⚠️ Heat Stabilized – This grade is heat stabilized, ensuring consistent performance at elevated temperatures.
⚠️ Sterilization – This grade is compatible with gamma and EtO sterilization. For medical applications, validate sterilization methods with actual part geometry.
⚠️ Storage – Store in original, sealed packaging in a cool, dry place away from direct sunlight. For subsequent storage, the material should be stored dry until processed.
Comparison: VESTAMID Care ML94 vs. VESTAMID Care ML24
| Feature | VESTAMID Care ML94 | VESTAMID Care ML24 |
|---|---|---|
| Filler Content | Unfilled | Unfilled |
| Viscosity | Medium | High |
| Key Feature | Heat stabilized, balanced flow | Heat stabilized, high melt strength |
| Tensile Modulus | 1,350 – 1,440 MPa | 1,400 MPa |
| Tensile Strength (Yield) | 45 MPa | 47 MPa |
| Elongation at Break | >50% | >50% |
| Density | 1.01 g/cm³ | 1.01 g/cm³ |
| Molding Shrinkage | 0.85% | 0.65% |
| MVR | 110 cm³/10 min | 36 cm³/10 min |
| Charpy Notched Impact (23°C) | Complete Break | 16 kJ/m² |
| Primary Application | Catheters, housing parts, monitoring devices | Catheters, tubing, encapsulation |
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Technical Documents for VESTAMID Care ML94
| Document Type | Description & Source |
|---|---|
| Manufacturer Official TDS | Complete physical, thermal, and mechanical properties of VESTAMID Care ML94 |
| Manufacturer Official SDS | GHS-compliant safety documentation |
| COA (Certificate of Analysis) | Batch-specific quality certification for VESTAMID Care ML94 |
| Biocompatibility Certification | USP Class VI and ISO 10993 documentation |
| Medical Device Compliance | FDA and EU medical device requirements documentation |
Request any document above by:
📧 Email: ruiqingchem@gmail.com
📝 Online form: Our contact page
We reply within one working business day. Please clearly state product (VESTAMID Care ML94) and document type you require.
FAQ about VESTAMID Care ML94
Q1: What is VESTAMID Care ML94?
A: VESTAMID Care ML94 is an unfilled, medium viscosity, heat stabilized polyamide 12 (PA12) resin from Evonik, specifically developed for medical applications.
Q2: What does the “Care” designation mean?
A: The “Care” designation indicates this grade is specifically developed for medical applications, with biocompatibility tested following ISO 10993-1 recommendations.
Q3: What are the key features of VESTAMID Care ML94?
A: Unfilled; medium viscosity; heat stabilized; USP Class VI & ISO 10993 compliant; high flexibility & elasticity; good rebound properties; high impact resistance; high toughness; high abrasion resistance; low sliding friction; high chemical resistance; gamma and EtO sterilizable; plasticizer-free.
Q4: What are the typical applications for VESTAMID Care ML94?
A: Catheters, medical tubing, encapsulation, medical device housings, monitoring and imaging devices, and durable medical equipment.
Q5: What is the recommended drying condition for VESTAMID Care ML94?
A: Dry at 80–90°C for 4–6 hours. Maximum residual moisture should be ≤ 0.10%.
Q6: What is the density of VESTAMID Care ML94?
A: 1.01 g/cm³.
Q7: What is the tensile modulus of VESTAMID Care ML94?
A: 1,350 – 1,440 MPa.
Q8: What regions is VESTAMID Care ML94 available in?
A: Europe and North America.
Q9: Is VESTAMID Care ML94 USP Class VI compliant?
A: Yes, it fulfills the requirements of USP <88> Class VI.
Q10: Is VESTAMID Care ML94 ISO 10993 compliant?
A: Yes, it has been tested for cytotoxicity, sensitization, irritation, and acute systemic toxicity following ISO 10993 recommendations.
Q11: What sterilization methods are compatible with VESTAMID Care ML94?
A: It is compatible with gamma and EtO sterilization.
Q12: Is VESTAMID Care ML94 suitable for extrusion?
A: No, VESTAMID Care ML94 is primarily processed by injection molding.
Q13: What is the molding shrinkage of VESTAMID Care ML94?
A: 0.85% parallel and 1.2% transverse.
Q14: What is the melt temperature range for VESTAMID Care ML94?
A: 210–270°C, with an optimum of 230–250°C.
Q15: What is the melt volume rate of VESTAMID Care ML94?
A: 110 cm³/10 min (275°C/5 kg).
Q16: What is the difference between VESTAMID Care ML94 and VESTAMID Care ML24?
A: VESTAMID Care ML94 is a medium viscosity, heat stabilized grade with a higher MVR (110 vs. 36 cm³/10 min), offering excellent flow for catheters, housing parts, and monitoring devices. VESTAMID Care ML24 has a higher viscosity (lower MVR), providing higher melt strength for demanding applications like encapsulation and extrusion.
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Sample Policy:
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Samples of VESTAMID Care ML94 are for laboratory validation tests only, not for production use.
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Buyer bears international sample-shipping freight.
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If bulk-product performance deviates from sample reference, the manufacturer’s official TDS serves as the authoritative benchmark.
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After-Sales Support
| Service | Details |
|---|---|
| Quality Inspection Period | All quality-related claims must be submitted within 7 working days after delivery, supported by test data and photographic evidence. |
| Return / Exchange Policy | Confirmed product defects caused by our side trigger replacement or refund. Terms and conditions apply. |
| Logistics Damage | Report shipping damage directly to carrier immediately upon goods receipt. We assist with claim-document preparation. |
| Technical Support | Remote technical guidance available. On-site troubleshooting can be arranged upon special request. |
| Export Documentation | We supply commercial invoice, packing list, bill of lading, COA, and additional compliance certificates on request. |
Disclaimer
DISCLAIMER: All technical data is referenced from original manufacturer typical values for VESTAMID Care ML94. Our company acts as supplier/trader rather than original manufacturer. Final performance depends on processing conditions and part design. Buyers shall independently validate product suitability for individual applications, especially for medical applications where regulatory compliance must be verified for each specific use case. Our firm bears no liability for product failure caused by improper processing or improper usage. Always reference the latest manufacturer official TDS of VESTAMID Care ML94 as the definitive specification.
