Product Certifications and Compliance

ISO 13485:2016:

Quality Management Systems: Ensures the PCB manufacturing process complies with the stringent requirements for medical device quality management systems, ensuring reliability and safety.

Traceability: Implements full traceability of all components and materials used in the PCB, critical for medical applications.

UL Certification:

Safety Standards: UL certification ensures that the PCBs meet the required safety standards for electronic components, providing assurance of their reliability and safety in medical devices.

Fire Safety: Confirms that the materials used in the PCB have been tested for fire resistance, which is crucial in medical environments.

RoHS (Restriction of Hazardous Substances):

Environmental Compliance: Guarantees that the PCB is free from hazardous substances like lead, mercury, and cadmium, making it safe for both users and the environment.

Health and Safety: Ensures that the PCB meets health and safety standards, reducing the risk of exposure to toxic substances.

IPC Class 3:

High Performance: IPC Class 3 certification indicates that the PCB meets the highest standards for performance and reliability, essential for critical medical applications.

Stringent Testing: Involves rigorous testing and inspection processes to ensure the highest quality and reliability.

CE Marking:

European Compliance: Confirms that the PCB complies with the essential requirements of relevant European health, safety, and environmental protection legislation.

Market Access: Allows the PCB to be sold in the European Economic Area, demonstrating adherence to EU standards.

Compliance with Industry Standards

IEC 60601:

Medical Electrical Equipment: Ensures the PCB meets the general safety and essential performance requirements for medical electrical equipment.

Risk Management: Incorporates risk management processes in compliance with IEC 60601, ensuring that potential hazards are identified and mitigated.

ISO 14971:

Risk Management: Adheres to the application of risk management to medical devices, ensuring the PCB is safe for use in medical applications.

Comprehensive Evaluation: Includes risk analysis, evaluation, control, and monitoring processes to maintain safety throughout the product lifecycle.

FDA Regulations (21 CFR Part 820):

Quality System Regulation: Ensures the PCB manufacturing process complies with FDA regulations for quality systems in the production of medical devices.

Good Manufacturing Practices (GMP): Implements GMP standards to ensure the PCB is manufactured consistently and meets all required quality specifications.

ASTM Standards:

Material and Testing Standards: Complies with ASTM standards for materials and testing methods, ensuring the PCB is of high quality and reliable for medical use.

Performance Validation: Ensures the PCB's performance meets the stringent requirements of medical applications.

ISO 9001:

Quality Management Systems: Certifies that the PCB manufacturing process adheres to ISO 9001 quality management principles, ensuring continuous improvement and customer satisfaction.

Process Control: Implements effective process controls to maintain high standards of quality and reliability.

ESD (Electrostatic Discharge) Standards:

Static Control: Ensures the PCB design and manufacturing process include measures to prevent electrostatic discharge, protecting sensitive medical electronics.

Safe Handling: Establishes protocols for safe handling and assembly to minimize the risk of ESD damage.

Summary

Our PCBs for medical device equipment are designed and manufactured to meet the highest standards of quality and safety, with certifications including ISO 13485, UL, RoHS, IPC Class 3, and CE marking. They comply with industry standards such as IEC 60601, ISO 14971, FDA regulations, ASTM standards, ISO 9001, and ESD standards. These certifications and compliances ensure that our PCBs provide reliable performance and safety in critical medical applications, meeting the stringent requirements of the healthcare industry.