Non-toxic Radiopaque Compound for Medical Devices: Innovation and Safety

In the medical and diagnostic sector, the demand for radiopaque, non-toxic, and processable materials is constantly growing.
X-ray shielding thermoplastic compounds, such as those from the LATIGRAY family, offer a concrete response to the needs for radiological traceability, biocompatibility, and sustainability required by modern medical equipment.

Radiopacity and Non-Toxicity: Key Requirements in Medical Devices

Implantable or diagnostic devices that need to be visible to X-rays — such as catheters, markers, surgical clips, or endoscopic instruments — require materials with high density and radiographic contrast.
Traditionally, this function was entrusted to heavy metals such as lead, which are increasingly excluded today due to toxicity and disposal difficulties.

Tungsten-based radiopaque compounds therefore represent an innovative and safe solution, capable of ensuring X-ray visibility without compromising the material’s biocompatibility.

LATIGRAY 82-03 CW/96: PA12-based Radiopaque Compound

Among the most advanced materials in the sector, LATIGRAY 82-03 CW/96 stands out, an X-ray shielding thermoplastic compound developed by LATI for medical and diagnostic applications.
Its PA12-based formulation combines a flexible and chemically inert thermoplastic matrix with a load of over 90% by weight of tungsten, ensuring excellent radiological shielding and certified non-toxicity.

Certified Non-Toxicity According to ISO 10993-5

LATIGRAY 82-03 CW/96 Natural 0193F3 has successfully passed the cytotoxicity tests required by the ISO 10993-5 standard, demonstrating absence of cellular reactivity and suitability for transient contact with biological tissues.
This result qualifies it as a non-cytotoxic material, suitable for the production of non-permanently implantable medical components.

Tested property	Result	Reference standard
Cytotoxicity (cellular reactivity)	Absent (grade 0)	ISO 10993-5
Type of contact	Transient (non-permanent)	—
Base material	PA12	—
Functional filler	>90% tungsten	—
Compound density	~11 g/cm³	ISO 1183

Technical Performance and Processability

Despite the high metal content, LATIGRAY 82-03 CW/96 maintains excellent processability characteristics and mechanical strength.
Thanks to its high melt fluidity, it is possible to obtain complex and thin moldings without defects or voids, even with difficult geometries or thicknesses less than a millimeter.

Main Properties of LATIGRAY 82-03 CW/96

Characteristic	Value or description	Technical advantage
Polymer base	PA12	Low hygroscopicity and excellent dimensional stability
Radiopaque filler	Tungsten powder >90%	Superior shielding to lead
Density	~11 g/cm³	High X-ray visibility
Non-toxicity	Compliant with ISO 10993-5	Guaranteed biological safety
Standard color	Dark gray (natural)	High visual contrast
Customizable options	Colored versions available upon request	Functional or aesthetic identification

Superior Radiopacity: Comparison with Traditional Materials

Material	Density (g/cm³)	Radiopacity	Toxicity	Notes
Lead (Pb)	11.3	Very high	High	Toxic, not suitable for medical use
Barium sulfate (BaSO₄)	4.5	Medium	Safe	Used in standard radiopaque fillers
Tungsten (W)	19.3	Very high	Safe in bound form	Eco-friendly alternative
LATIGRAY 82-03 CW/96 (PA12 + W)	~11	High	Non-toxic	Excellent performance/safety compromise

Thanks to its high density and homogeneous distribution of tungsten particles, LATIGRAY 82-03 CW/96 offers clear and sharp radiographic visibility, even in reduced thicknesses, making it ideal for markers and diagnostic components.

Applications in the Medical Sector

The non-toxic radiopaque compounds such as LATIGRAY 82-03 CW/96 find application in a wide range of medical and diagnostic devices:

• Surgical positioning markers and clips
• X-ray visible seals and casings
• Components for medical catheters and tubing
• Radio-visible fasteners and guides
• Instruments for radiology and in vivo diagnostics

In all these applications, the combination of radiopacity, non-toxicity, and mechanical stability is fundamental to ensure safety, traceability, and reliability.

Advantages of the LATIGRAY 82-03 CW/96 Radiopaque Compound

Advantage	Description
Certified non-toxicity	Compliant with ISO 10993-5, non-cytotoxic
Superior radiopacity	X-ray shielding greater than lead
Excellent processability	Injection molding even for complex geometries
Chemical compatibility	Resistant to disinfectants and sterilizations
Sustainability	Free from lead and toxic metals, easy to dispose of

FAQ – Frequently Asked Questions about Non-Toxic Radiopaque Compounds for Medical Devices

1. What is the difference between a radiopaque compound and a traditional one?
   A radiopaque compound is formulated with high-density metallic fillers (such as tungsten) that make it visible to X-rays, an essential characteristic in traceable medical devices.
2. Is tungsten safe for medical applications?
   Yes, in bound form within the polymer matrix, tungsten is chemically stable and non-toxic, compliant with the requirements of the ISO 10993-5 standard.
3. Is it possible to customize the color of the radiopaque compound?
   Yes, in addition to the natural dark gray version, colored variants are available for functional or aesthetic identification.

Conclusion

The non-toxic radiopaque compound for medical devices, such as LATIGRAY 82-03 CW/96, combines high shielding performance, biocompatibility, and thermoplastic processability, representing a valid alternative to traditional metallic materials.

💡 Do you want to develop a radio-visible and safe medical component?
Request a LATI technical consultation to identify the most suitable radiopaque compound for your diagnostic or medical device project.