Linda Liu , Marketing Manager, MKTPCB08.18.21
As the medical industry embraces automation, most diagnostic and treatment devices require PCBs with miniaturized and high-density interconnect capacities to support more components in a small area while guaranteeing high performance. The industry calls for the highest quality standards and reliability from PCB products. This article discusses the PCB design considerations and standards for medical devices.
Manufacturing Standards for Medical Devices and Equipment
Medical gadgets and equipment go through more stringent rules and regulations than other electronics. This is because the failure of medical products to function appropriately can cause detrimental impacts, like loss of human life. Thus, each phase of healthcare electronic development undergoes mandatory regulatory oversight to guarantee the best quality and accuracy of the end products.
Medical electronics go through a clear quality management system (QMS) to detect and remove any errors. Acquiescence with such standards is confirmed via various testing routines. The common medical electronic manufacturing standards include:
Applying these standards in your medical electronic designs will help you to create high-quality, reliable products for healthcare use. Your control manufacturer (CM) will also affect the likelihood of your electronics satisfying the above standards. Your preferred CM should be able to fabricate the highest quality boards. Importantly, he should also be experienced to help you make the right decisions when stuck. By partnering with a reputable and experienced CM, you will exploit effective production practices and machinery.
Considerations for Designing Medical Electronic Products
1. Precision
The first consideration for designing medical electronic devices you should bear in mind is precision, irrespective of whether it is associated with the safety or performance of the device. Nevertheless, when accuracy is safety or performance-oriented, you must proceed carefully.
What are the accuracy levels of your equipment, and what are the effects of not meeting the specified precision requirements. How will you gauge the accuracy in the verification of your electronics? How will the precision of your gadget change throughout the lifespan of the device, and how will you confirm that your product will continue to be accurate throughout its lifespan? Those are some of the questions that you should ask yourself regarding the accuracy aspect of your medical electronic product.
2. Lifespan
Lifespan is essential in determining the accuracy and longevity of medical devices and equipment. In most electronics, the mechanisms are the common points of failure, meaning they influence an electronic’s projected lifespan or maintenance plan. Therefore, ensure you consider the effects of repair calls and replacements when selecting a machine with minimal reliability. Create an advance plan about your maintenance service provider and frequency of services to maintain the high performance of your medical equipment throughout their lifespan.
3. Travel Limits
A prior understanding of the expected travel limit, precision of the final detection, and the impacts of exceeding the limits will enable creating an all-inclusive design from the beginning. Suppose the method is not activated/there are no manual movements. You should fit your gadget with regulation switches, encoders, and other detectors to relay information with a high level of accuracy.
In healthcare, the accomplishment or failure of such sensors significantly affects the safety of the gadget. IEC 60601 stipulates that these devices should be single-failure safe, meaning their chances of failure should be examined carefully and emergencies considered. In some cases, you may make some sensors inactive or introduce hard halts in sensor failures. Additionally, you can apply a highly reliable sensor or sensors with inbuilt alerts to minimize the risk of unforeseen failure.
4. Mechanical Safety
When a user applies a certain mechanism, obviously, there are theft or crushing threats. As a medical electronic manufacturer, you should prevent such threats as much as possible. Consider standards like IEC 60601-01, which outlines the standard aspects of emergency stops.
5. Debris
Some medical equipment forms debris when they come in contact with other surfaces. Debris, such as dust, oil, gear, or chopped human hair can hinder biological tests, leading to inaccuracies. Oil and dust can even enter inside the devices and interfere with their normal functioning. Therefore, ensure that end-users understand the effects of debris on your medical electronic products. This will maintain the high performance of the devices and prolong their lifespan.
6. Marginal Cases
It is essential to take note of the marginal cases of a healthcare device’s projected application environment. You should ask yourself some important questions: What will happen when the electronics are bumped, switched off, or interrupted when it is working? Which temperature conditions does it perform optimally?
These are likely causes of safety problems, and therefore, you should consider them in your risk management plan. If left unattended, they can lead to expensive field problems, minimal or no application, and more repairs and maintenance requirements. While projecting marginal cases is easy, it consumes a lot of time. But it is less time-intensive than regular repairs.
7. Usability
Finally, you should consider the usability of your device since it can boost or hinder its performance. A poor design will automatically lead to failure in usability validation. Therefore, consider the amount of energy needed to run it. At which level will it perform/break? Does it produce any noise when running? Ensure you invest adequate time in the usability of your products to guarantee users a satisfied and effortless experience and successful market approval.
Conclusion
This article has offered a detailed discussion about PCB design considerations and standards for medical devices and equipment. Now that you have a good understanding of the topic, you can proceed to your project and implement the points we have covered. The success of your healthcare gadget and equipment development is dependent on integrating the set regulatory standards and considerations from the design stage.
Linda Liu is the overseas marketing manager for MKTPCB, a leading PCB manufacturer that offers high-quality PCB products and services. Since 2012, she has established “first-of-its-kind” industry-changing and transformational businesses initiatives that increased revenue growth, brand exposure and market expansion for MKTPCB. Liugraduated from Western University with a bachelors degree in marketing.
Manufacturing Standards for Medical Devices and Equipment
Medical gadgets and equipment go through more stringent rules and regulations than other electronics. This is because the failure of medical products to function appropriately can cause detrimental impacts, like loss of human life. Thus, each phase of healthcare electronic development undergoes mandatory regulatory oversight to guarantee the best quality and accuracy of the end products.
Medical electronics go through a clear quality management system (QMS) to detect and remove any errors. Acquiescence with such standards is confirmed via various testing routines. The common medical electronic manufacturing standards include:
- The FCC Title 47 rules:These guidelines are made and printed by the Government Printing Office (GPO).
- The Food & Drug CFR Section 807:The FDA’s Center for Devices and Radiological Health (CDRH) regulates companies producing, repackaging, re-labeling, and dealing with medical electronics in the US.
- IEC 60601-1:This guideline outlines the standard aspects of medical electronics.
- IEC 61010-1:It stipulates the standard safety guidelines for electrical equipment and related components.
- IPC 6011:These are basic performance specifications for PCBs.
- ISO 13485 Medical Equipment:This standard is meant for businesses and persons dealing with the design, manufacturing, installation, and servicing of healthcare equipment and gadgets. In addition, certification agencies can use it in their auditing practices.
- ISO 14971:2007:This standard outlines the due process for medical electronic manufacturers to detect any hazard in medical devices.
Applying these standards in your medical electronic designs will help you to create high-quality, reliable products for healthcare use. Your control manufacturer (CM) will also affect the likelihood of your electronics satisfying the above standards. Your preferred CM should be able to fabricate the highest quality boards. Importantly, he should also be experienced to help you make the right decisions when stuck. By partnering with a reputable and experienced CM, you will exploit effective production practices and machinery.
Considerations for Designing Medical Electronic Products
1. PrecisionThe first consideration for designing medical electronic devices you should bear in mind is precision, irrespective of whether it is associated with the safety or performance of the device. Nevertheless, when accuracy is safety or performance-oriented, you must proceed carefully.
What are the accuracy levels of your equipment, and what are the effects of not meeting the specified precision requirements. How will you gauge the accuracy in the verification of your electronics? How will the precision of your gadget change throughout the lifespan of the device, and how will you confirm that your product will continue to be accurate throughout its lifespan? Those are some of the questions that you should ask yourself regarding the accuracy aspect of your medical electronic product.
2. Lifespan
Lifespan is essential in determining the accuracy and longevity of medical devices and equipment. In most electronics, the mechanisms are the common points of failure, meaning they influence an electronic’s projected lifespan or maintenance plan. Therefore, ensure you consider the effects of repair calls and replacements when selecting a machine with minimal reliability. Create an advance plan about your maintenance service provider and frequency of services to maintain the high performance of your medical equipment throughout their lifespan.
3. Travel Limits
A prior understanding of the expected travel limit, precision of the final detection, and the impacts of exceeding the limits will enable creating an all-inclusive design from the beginning. Suppose the method is not activated/there are no manual movements. You should fit your gadget with regulation switches, encoders, and other detectors to relay information with a high level of accuracy.
In healthcare, the accomplishment or failure of such sensors significantly affects the safety of the gadget. IEC 60601 stipulates that these devices should be single-failure safe, meaning their chances of failure should be examined carefully and emergencies considered. In some cases, you may make some sensors inactive or introduce hard halts in sensor failures. Additionally, you can apply a highly reliable sensor or sensors with inbuilt alerts to minimize the risk of unforeseen failure.
4. Mechanical Safety
When a user applies a certain mechanism, obviously, there are theft or crushing threats. As a medical electronic manufacturer, you should prevent such threats as much as possible. Consider standards like IEC 60601-01, which outlines the standard aspects of emergency stops.
5. Debris
Some medical equipment forms debris when they come in contact with other surfaces. Debris, such as dust, oil, gear, or chopped human hair can hinder biological tests, leading to inaccuracies. Oil and dust can even enter inside the devices and interfere with their normal functioning. Therefore, ensure that end-users understand the effects of debris on your medical electronic products. This will maintain the high performance of the devices and prolong their lifespan.
6. Marginal Cases
It is essential to take note of the marginal cases of a healthcare device’s projected application environment. You should ask yourself some important questions: What will happen when the electronics are bumped, switched off, or interrupted when it is working? Which temperature conditions does it perform optimally?
These are likely causes of safety problems, and therefore, you should consider them in your risk management plan. If left unattended, they can lead to expensive field problems, minimal or no application, and more repairs and maintenance requirements. While projecting marginal cases is easy, it consumes a lot of time. But it is less time-intensive than regular repairs.
7. Usability
Finally, you should consider the usability of your device since it can boost or hinder its performance. A poor design will automatically lead to failure in usability validation. Therefore, consider the amount of energy needed to run it. At which level will it perform/break? Does it produce any noise when running? Ensure you invest adequate time in the usability of your products to guarantee users a satisfied and effortless experience and successful market approval.
Conclusion
This article has offered a detailed discussion about PCB design considerations and standards for medical devices and equipment. Now that you have a good understanding of the topic, you can proceed to your project and implement the points we have covered. The success of your healthcare gadget and equipment development is dependent on integrating the set regulatory standards and considerations from the design stage.
Linda Liu is the overseas marketing manager for MKTPCB, a leading PCB manufacturer that offers high-quality PCB products and services. Since 2012, she has established “first-of-its-kind” industry-changing and transformational businesses initiatives that increased revenue growth, brand exposure and market expansion for MKTPCB. Liugraduated from Western University with a bachelors degree in marketing.
