1. Core Requirements for Identification Technology in the Medical Industry
Permanent Markings: Must comply with ISO 15223-1 standards to ensure traceability throughout the lifecycle of instruments.
Biocompatibility: The marking process must not alter the surface properties of materials, avoiding chemical contamination risks.
Sterilization Tolerance: Marks must withstand high-temperature and high-pressure sterilization processes as well as gamma-ray sterilization.
Micron-Level Precision: Meeting the precise processing needs of orthopedic implants and minimally invasive surgical instruments.
Laser marking technology achieves non-destructive marking on over 300 types of medical materials, including 316L stainless steel, titanium alloys, and medical polymers, by adjusting wavelength (1064nm fiber lasers, 355nm UV lasers), pulse frequency (20kHz-200kHz), and power density (5W-50W). The minimum line width can reach 15μm, fully meeting the strict requirements of FDA and CE certification for medical device markings.
2. Analysis of Four Core Application Scenarios
- Full-Process Traceability of Surgical Instruments
Directly engraving unique device codes (UDI) on the surfaces of needle holders and hemostatic forceps.
Using UV cold lasers to mark batch information on the joint parts of laparoscopic instruments.
Case: A German instrument manufacturer has achieved 0.02mm depth control through a fiber laser marking system, making marks resistant to 300 cycles of high-temperature sterilization. - Identity Authentication System for Implants
Carving three-dimensional microstructure anti-counterfeiting codes on the surfaces of artificial joints.
Circular marking technology on the inner walls of blind holes in orthopedic screws.
Data: Laser marking increases the efficiency of implant traceability by 70%, reducing recall response time to 2 hours. - Safety Upgrade of Pharmaceutical Packaging
Laser engraving of batch numbers on the necks of glass ampoules.
Generating invisible anti-counterfeiting marks on blister aluminum foil using CO2 lasers.
Innovative Application: Laser micropore marking technology for biodegradable stents, with hole size accuracy ±5μm. - Intelligent Management of Laboratory Consumables
Automated laser coding of batch numbers on microcentrifuge tubes.
Precise positioning marking of PCR plates with 384-well matrices.
Test Data: UV laser marking speed on PETG material surfaces reaches 1200 characters per minute.
3. Key Parameter Guide for Technical Selection
Parameter Dimension Stainless Steel Instruments High Polymer Consumables Glass Drug Packaging Laser Type Fiber Laser UV Laser CO2 Laser Wavelength Range 1064nm 355nm 10.6μm Power Density 30W-50W 3W-8W 10W-30W Marking Depth 10-50μm Surface Modification Micro-crack Control Minimum Line Width 20μm 15μm 50μm
4. Prospects for Industry Development Trends
Intelligent Integration: Deep integration of laser marking systems with MES systems for real-time synchronization of production data.
Green Manufacturing: Non-consumable, low-energy technology aligns with the ESG development requirements of the medical industry.
Composite Processing: Specialized workstations integrating cutting, welding, and marking functions for medical use.
Micro-Nano Manufacturing: Surface microstructure processing technology for drug-eluting stents.
Synmark Laser Solutions, as a professional manufacturer of medical-grade laser equipment, offers:
✅ Customized solutions compliant with the ISO 13485 quality system
✅ Traceability systems supporting 21 CFR Part 11 compliance
✅ Free access to material adaptability testing laboratories
✅ 7×24-hour remote technical support
To immediately obtain the white paper on laser marking in the medical industry, please send your request to: info@synmarklaser.com
Technical consultation hotline: +86-158-0666-7020
