ISO 13485 עבור PCBA רפואי: כיצד הוא מבטיח איכות ללא פגמים במכשירים קריטיים לחיים

Do you have a medical device that needs zero-defect quality? Read along to know more about the ISO 13485 Quality Management System.

Medical devices are equipment that can diagnose, monitor, or even treat some illnesses. These devices interact with human beings with medical conditions. With this, they should be safe, compliant, reliable, and maintained. One such standard, ISO 13485, ensures quality management throughout the device’s lifecycle. UET PCB is one of the PCB manufacturers certified to ISO 13485 for the manufacturing of PCBs for medical devices.

 

מה זה ISO 13485

ISO 13485 is a Quality Management System for medical devices with a global scope. This system is employed by medical device manufacturers, suppliers, component manufacturers, service providers, certification bodies, and quality teams. The main goal of ISO 13845 is to ensure that medical devices are designed, manufactured, and delivered safely and reliably, in compliance with regulatory requirements. Another characteristic of ISO 13485 is that it serves as an umbrella for the various QMSs and standards for the production and maintenance of medical devices.

 

Processes where ISO 13485 can be applied in the medical device lifecycle

תהליכים	תוֹצָאָה
מחקר ועיצוב	Document design procedures Must comply with safety and regulatory compliance ניהול סיכונים
Purchasing of Materials	Components & materials should be certified as medical grade Should be biocompatible with humans and can be sterilized if needed
הפקה	Ensure equipment calibration Work in a cleanroom environment Production procedures should be well-documented and traceable
בדיקות	The testing process should be documented and traceable Tests include functional and safety tests
הפצה	The distribution process should incorporate sterile packaging Include documentation and traceability
תחזוקה	Only certified technicians should service medical-grade devices Documentation and traceability should be maintained
פוסט מכירות	Ensure scheduled calibration of certain devices Gathering of customer data for continuous improvements

 

How to Ensure Zero-Defect Quality in Life-Critical Devices

Life-saving equipment, such as ventilators/respirators, dialysis machines, and surgical equipment, must meet zero-defect quality standards. These devices must be designed and manufactured to meet the highest quality standards for medical devices. To achieve this, the devices should comply with ISO 13845 (QMS for medical devices), ISO 14971 (Risk management for medical devices), and other electrical, safety, and software standards. Additionally, continuous monitoring and calibration are required to maintain proper device functionality.

 

Processes for Zero Defect Quality

Apply Design and Risk Management

• Both ISO 13845 (QMS for medical devices) and ISO 14971 (Risk management) standards should be applied when manufacturing medical devices.
• Apply safety, diagnostic, and redundant systems to the device.

 

Material Sourcing should be Carefully Controlled.

• Only medical-grade materials should be used.
• Ensure reliability and traceability of components with relation to their suppliers and manufacturers.

 

Apply Good Manufacturing Practices (GMP)

• Apply a QMS such as ISO13485
• Ensure environmental control, such as a clean room environment
• Manufacturing equipment should be calibrated and maintained
• Every aspect of manufacturing should be well documented

 

Apply Rigorous Device Testing

• Biocompatibility testing for devices that interact with humans
• EMC (Electromagnetic Compatibility) testing prevents interference with other equipment
• Electrical safety testing to test voltage, current, grounding, insulation, etc.
• Apply Design Validation Test (DVT)

Apply Software Validation

• Apply IEC 62304 (software standard for medical devices) and ISO 14971 (risk management)
• Monitor bugs and cybersecurity risks
• Apply version control & configuration management
• Apply good software testing practices

 

תחזק את הציוד

• Regular scheduled maintenance and calibration
• Every maintenance should be documented and traced

 

Sustaining Activities

• Equipment should be monitored in the field and serviced if needed
• Data gathering of failure rates and inconsistencies in the field
• Data gathered should be fed back to design and engineering

 

Why PCB Suppliers must have it?

PCB suppliers and manufacturers will always have an advantage if they implement ISO 13485 in their manufacturing workflow.

 

1. The manufactured device is safer for the patients.
2. Compliance with international standards such as the FDA, Health Canada, and EU MDR
3. Customer trust is achieved through the reliability of the device
4. Compliance opens access to the global market
5. Easier audit on materials and components due to tracking and traceability

 

ISO 13485 Example Case Studies

Pacemaker Device

פוקוס: A pacemaker device is critical to the survival of a patient with a heart problem

 

גישה: The device should be reliable and have a good battery life. It should be a failsafe and have redundancy features. Additionally, it should be resistant to outside electrical interference.

 

אישורים: ISO 13485, ISO 14971, IEC 60601, IEC 62304, ISO 10993 

 

תוצאות:

Since ISO 13485 harmonizes various standards, this QMS should ensure product quality and consistency throughout its lifecycle. ISO 14971 ensures the product’s failsafe feature and redundancy. IEC 60601 addresses electrical safety and performance, including EMC compliance.

 

Blood Analyzer Equipment

 

פוקוס:  A blood analyzer equipment (hematology analyzer) is to be manufactured by a PCB supplier to analyze blood samples in a hospital setting.

 

גישה: The blood analyzer should be easy to use, highly accurate, and capable of outputting multiple parameters. Incorrect readings can be catastrophic for the patient involved.

 

אישורים: ISO 13485, ISO 14971, IEC 60601, ISO 10993, IEC 62304, ISO 17025 

 

תוצאות: 

As before, ISO 13485 is a collection of standards intended to ensure a quality, safe device. Similarly, ISO 14971, IEC 60601, and ISO 10993 address risk management, electrical safety, EMC, and biocompatibility, respectively. As the blood analyzer outputs several critical parameters, the software/firmware should comply with IEC 62304 (the software development lifecycle for medical devices). ISO 17025 ensures the accuracy of the device through rigorous testing, consistent monitoring, and calibration.

 

סיכום

ISO 13485 is a QMS designed to harmonize various certifications and standards for the production and maintenance of critical medical devices. Its goal is to ensure the device is safe, reliable, and free of risks. ISO 13485 is a crucial component if you want to become a medical device manufacturer.

 

To achieve zero-defect quality in life-critical devices, you need to employ ISO 13485, along with other ISO and IEC standards (e.g., ISO 14971, IEC 62304, IEC 60601, and ISO 10993, to name a few). This process ensures design and risk management, credible material sourcing, good manufacturing practices (GMP), rigorous device testing, software validation, and equipment maintenance.