As a product operation and marketing specialist at Shenzhen Dome Materials Co., LTD., I’ve helped numerous healthcare manufacturers solve laser marking challenges. Medical devices demand permanent, safe, and readable markings for traceability and patient safety. These markings must meet strict FDA and ISO standards without exception.

This guide explains how DOME’s medical-grade laser marking additives deliver high-contrast, durable marks on plastics like PC, ABS, and TPU—while fully complying with FDA 21 CFR Part 177 and ISO 10993 biocompatibility requirements.

Why Medical Device Marking Must Meet Strict Standards

Markings on plastic medical devices aren’t optional—they ensure Unique Device Identification (UDI), recalls, and patient safety.

Regulatory bodies like the FDA and ISO require three core standards:

• Permanent clarity — Marks remain legible throughout the device’s entire lifecycle, including heavy use and repeated cleaning.
• No harmful substances — Additives must not leach toxins; biocompatibility prevents health risks.
• Sterilization resistance — Marks survive gamma irradiation (25kGy), steam autoclave (121°C for 30 min), ethylene oxide (EO), and cleaning cycles.

Traditional methods or generic additives often fail to meet these demands for common medical plastics.

3 Common Challenges in Laser Marking Medical Plastics (PC, ABS, TPU)

These materials offer durability and biocompatibility but pose laser marking issues:

1. Low laser absorption and poor contrast. Transparent or light-colored plastics (e.g., clear PC syringes) let laser energy pass through, creating faint marks. Opaque versions may show uneven results, failing UDI readability.
2. Mark fading or peeling after sterilization, Gamma rays, high-heat steam, or EO often degrade weak bonds, erasing codes and risking regulatory non-compliance, plus traceability loss.
3. Safety or processing risks. Some additives use heavy metals, phthalates, or BPA—banned in medical applications. Others disrupt molding, causing defects, downtime, or precision loss.

How DOME Additives Solve These Challenges with Dual FDA/ISO Compliance

DOME’s medical-grade laser marking additives and masterbatches are designed specifically for medical plastics. They provide safe, high-performance marks without compromising production.

1. 100% Safe, Heavy Metal-Free Composition

• Free of heavy metals, phthalates, and BPA.
• Fully compliant with FDA 21 CFR Part 177 (limits chemical migration for food/medical contact).
• Meets ISO 10993 biocompatibility—even for implants.

2. Proven Resistance to Harsh Sterilization

• Forms strong molecular bonds with PC, ABS, or TPU.
• Withstands 25kGy gamma irradiation, 121°C steam (30 min), EO, and 200+ alcohol wipes.
• No fading, peeling, or clarity loss—ensures lifelong UDI compliance.

3. Seamless Integration into Manufacturing

• Works in standard injection molding and extrusion—no parameter changes needed.
• Preserves mechanical properties (flexibility, strength, smoothness).
• Avoids defects like bubbles, sink marks, or edge burn—even on micro-components.

Real-World Applications: Proven Results

• Disposable PC Syringes. A leading manufacturer achieved crisp black UDI codes (0.05mm min. line width) on transparent syringes. Marks stayed 100% readable post-gamma sterilization and alcohol wipes—passing all FDA migration tests.
• Reusable ABS Surgical Instrument Handles: A tool producer eliminated fading after steam cycles. DOME additives delivered scratch-resistant marks over 50+ sterilizations, while keeping grip texture and strength intact.

Full Certification Support to Simplify Compliance

We supply complete test reports with every batch, including:

• FDA 21 CFR Part 177 compliance docs
• ISO 13485 quality system certification
• Sterilization resistance results (gamma, steam, EO)
• ISO 10993 biocompatibility and migration reports

These accelerate your regulatory submissions and reduce risks.

Choose DOME for Reliable, Compliant Medical Laser Marking

In medical manufacturing, there’s no room for shortcuts on safety or compliance. DOME’s additives provide permanent, high-contrast marks that meet FDA and ISO dual requirements—while supporting efficient production.

We’re proud to partner with global healthcare manufacturers, delivering patient-centric solutions you can trust.

Ready to improve your laser marking process? Contact DOME today to discuss certified additives tailored to your devices.