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Artech's Standards for Medical Device Safety and Performance

In the dynamic field of medical technology, it is crucial to uphold rigorous standards of safety, performance, and hygiene. At Artech, we are dedicated to meeting and surpassing these standards, ensuring that healthcare professionals worldwide trust our medical solutions. In this blog post, we will delve into the key certifications and compliances that underpin the excellence and reliability of our products, as well as the potential risks and harms that can arise without these certifications.

MDR Class I Certification

The Medical Device Regulation (MDR) Class I certification forms the foundation of our compliance framework. This certification ensures that our devices adhere to stringent European Union regulations for safety and performance. Without MDR Class I certification, medical devices may fail to meet basic quality and safety standards, potentially resulting in malfunctions or failures. Such issues can lead to misdiagnoses, compromised treatments, and serious patient harm, ultimately eroding confidence in medical technology.

MDR Class I certification also encompasses rigorous post-market surveillance, ensuring that any issues arising post-launch are promptly addressed to maintain product safety and efficacy.

IEC-60601 EMC and LVD Compliance

Artech's products fully comply with IEC-60601 standards for electromagnetic compatibility (EMC) and the low voltage directive (LVD). IEC-60601 EMC certification ensures that our devices can operate safely and effectively amidst electromagnetic interference. Without this certification, devices may malfunction due to electromagnetic interference, leading to erroneous data, interrupted operations, and even device failures during critical medical procedures. IEC 60601 LVD certification guarantees that our devices meet basic safety requirements for electrical equipment. Without LVD compliance, there is an increased risk of electrical hazards such as shocks or fires that endanger patients and healthcare workers.

IEC-60601 standards also cover key performance elements such as durability and reliability in the clinical environment, ensuring devices can withstand the rigors of daily use in busy medical settings.

Operating Room Hygiene Approval

Operating rooms require the highest hygiene standards to prevent infections and ensure patient safety. Artech's products are designed with these stringent requirements in mind and have earned Operating Room Hygiene Approval. Without this certification, devices can be difficult to clean and disinfect properly, increasing the risk of contamination. This can lead to hospital-acquired infections, prolonged patient recovery times, and a greater strain on healthcare resources. Ensuring that our devices meet hygiene standards is essential to maintaining a safe surgical environment.

Our Operating Room Hygiene Approval includes rigorous testing, such as bacterial and viral resistance tests, to ensure that our devices can be effectively sterilized without compromising their functionality or longevity.

IP65 Protection Level

The IP65 protection level showcases the durability and resilience of Artech products. This certification indicates that our devices are dustproof and protected against water jets. Without IP65 certification, devices can be vulnerable to dust and water ingress, leading to premature wear, malfunctions, and potential device failures. In critical medical environments, such failures can disrupt patient care, delay treatments, and jeopardize overall healthcare delivery.

The IP65 rating means our devices are also suitable for use in outdoor or mobile healthcare environments where exposure to dust and moisture is more likely, ensuring reliable operation under various conditions.

DICOM and Color Calibration

Accuracy and consistency are paramount in medical imaging. Artech's adherence to DICOM (Digital Imaging and Communications in Medicine) standards ensures that our imaging devices deliver precise and standardized images. Without DICOM compliance, medical images can lack the necessary accuracy and consistency, resulting in misdiagnoses and ineffective treatments. Additionally, our color calibration processes ensure that images are true to reality. Without proper color calibration, medical professionals may misinterpret imaging results, affecting patient outcomes.

Our DICOM compliance includes not only adherence to imaging standards but also integration capabilities with other DICOM-compliant systems, facilitating seamless interoperability and data sharing between different healthcare platforms.

ISO 13485 Certification

The ISO 13485 standard specifies the regulatory requirements for the design, manufacture, and market placement of medical devices. Having this certification guarantees that Artech's medical devices are manufactured with a quality management system that complies with the obligations imposed by the ISO 13485 standard. Without ISO 13485 certification, the safety and performance of medical devices could be at risk, jeopardizing patient health and leading to legal issues.

ISO 13485 includes risk management processes and supplier management, ensuring that our devices maintain high-quality standards.

Conclusion

At Artech, our certifications and compliances are not just checkboxes to be ticked; they are the pillars that ensure our products are safe, effective, and reliable. By strictly adhering to these standards, we fulfill our commitment to providing our customers with the highest quality products.