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Artech's Standards for Medical Device Safety and Performance

In today's rapidly evolving medical technology landscape, maintaining the highest standards of safety, performance, and hygiene is of utmost importance. At Artech, we ensure full compliance with international standards, guaranteeing that our medical devices are trusted by healthcare professionals worldwide. In this article, we explore the key certifications supporting our products' reliability and excellence, as well as the risks associated with uncertified devices.

MDR Class I Certification

The Medical Device Regulation (MDR Class I) certification ensures that our products meet the stringent safety and quality standards set by the European Union. Without this certification, devices may fail to meet essential quality standards, posing significant risks to patient safety. This could lead to misdiagnoses, treatment errors, and compromised patient health. MDR compliance also includes ongoing monitoring and post-market surveillance to ensure continued product safety and effectiveness.

IEC-60601 EMC and LVD Compliance

Artech products adhere to IEC-60601 standards for electromagnetic compatibility (EMC) and low voltage directive (LVD). Devices lacking these standards may experience electromagnetic interference, malfunction, or even critical failures during medical procedures. LVD compliance ensures electrical safety, reducing risks such as electric shocks or fire hazards that could endanger patients and healthcare personnel.

Operating Room Hygiene Certification

Medical devices used in sterile operating room environments must comply with strict hygiene standards. Artech products are designed for easy cleaning and have passed bacterial resistance tests, earning Operating Room Hygiene Certification. Devices without this certification may contribute to hospital-acquired infections, posing serious health risks to patients.

IP65 Protection Rating

Artech industrial and medical devices are IP65 certified, ensuring full protection against dust and water splashes. Devices without this level of protection may suffer from premature wear, malfunctions, and reduced lifespan due to dust or liquid exposure. In high-use environments, IP65 certification enhances durability and ensures long-term performance.

DICOM Compliance and Color Calibration

Accuracy in medical imaging technology is critical. Artech fully complies with the DICOM (Digital Imaging and Communications in Medicine) standard, delivering the highest accuracy and reliability in medical imaging. Devices without DICOM compliance risk misdiagnoses and incorrect treatment planning, endangering patient health.

ISO 13485 Certification

ISO 13485 is an international standard for quality management in medical device manufacturing. Artech products are designed and manufactured in full compliance with this certification. Devices lacking this certification may not undergo rigorous quality control processes, increasing safety and performance risks.

Conclusion: Reliable Medical Solutions with Artech

At Artech, we meticulously manage our certification and compliance processes, delivering the most reliable and highest-quality medical devices to the healthcare sector. Ensuring that medical devices meet international standards is crucial for patient safety and the efficiency of healthcare professionals. Achieve excellence in medical technology with Artech’s certified solutions!