Medical PCB Application
1. The scope of application of medical PCB
a. After we have explored military-grade PCBs, we will take something equally important and sensitive. Medical PCB used in medical devices. The present era is experiencing the best medical facilities.
b. It is inconceivable that the designers and manufacturers of medical electronic devices should shoulder their responsibilities day in and day out. They are responsible for the normal operation of medical devices, and so is the life of medical devices.
c. Health care ranges from small wearables that promote health to systemic imaging systems that analyze the health of internal organs.
d. patient care, research, or training of medical professionals are all part of the medical PCB world. Today, we find a variety of PCBs, from cardiovascular medical specifications to medical imaging systems. Whether it’s pacemakers, defibrillators, and cardiac monitors, or MRIs, CT scans, ultrasound devices, and more PCB applications.
e. You can also find PCBs for medical devices such as temperature monitors, blood glucose monitors, and electronic muscle stimulation devices.
2, Medical PCB developed technology and healthcare
a. PCBs meet the unique limitations of medical devices and are therefore highly specialized.
b. In most medical applications, a small package is required to meet the size requirements of an implant or an emergency room monitor.
c. In addition, the use of electricity in medical equipment should be as low as possible. It is critical that handhelds and other battery-powered devices have longer battery life.
d. Another very important aspect of the medical PCB is signal integrity. You need to trust that any connected device can transmit the correct signal within the expected time range.
e. Basically, medical PCBs are large-scale miniaturization. Therefore, medical PCBs tend to be high density interconnects or HDI boards.
f. But how small is it when discussing the miniaturization of electronic products in innovative medical technologies?
In the PCB market, a recent term is becoming viral, “miniaturization”. It is used to deliver drugs through implanted electronic devices. The technology has a strange name, “electroceuticals.”
3. Medical PCB: Rules and standards of application
a. I believe that at this point, what bothers you is the thought of electronic devices used in health centers. The accuracy of the medical device determines whether the condition has been correctly diagnosed and, therefore, appropriate treatment can be provided.
b. The accuracy of the operation or whether the expected prognostication is provided. The life of the person you love depends on these vivid factors, which will certainly make you dizzy. But don’t worry, because all medical electronics must follow a considerable number of safety and quality standards.
c. To ensure that medical devices meet their critical system performance requirements
International Electron Council (IEC)
International Standards Organization (ISO)
U.S. Food and Drug Administration (FDA)
Federal Communications Commission (FCC)
Other agencies issue medical device regulations and standards
The Company must comply with these regulations and standards for the construction and supply of medical equipment.
In terms of medical electronic design and development, the most widely used textbooks have been used for more than 14 years! Why?
To a large extent, these standards are geopolitically controlled. Each country has its own governing body and standards. Having said that, compliance with standards such as the IEC and ISO mainly covers all countries. Consider it in this way, the fact that medical devices are so different and used in many different fields. This means that specific requirements will be developed for specific devices, depending on how and where they are used.
Due to this changing nature of regulations, it is almost impossible to create a complete list. Electronic innovation in medical technology has been accelerating, and the list was out of date before it appeared.
However, there are some key rules that you should be aware of when providing medical equipment and equipment to your organization.
d.ISO 13485 Medical Devices: Quality Management System (QMS) – Standard for Regulatory Purposes
It defines specific requirements for the medical device industry regarding the entire sample space of QMS.
ISO 13485 is designed for organizations engaged in the design, production, installation and maintenance of medical equipment. It also enables internal and external parties, such as certification bodies, to conduct audits.
Medical devices are products, more accurately, instruments, machines, implants, or in-body reagents that assist in the diagnosis, prevention, and treatment of diseases.
e.ISO 14971 Medical Devices: Risk Management Applications for Medical Devices
This standard specifies the process equipment that manufacturers use to identify medical-related threats, including in vitro diagnostic (IVD) medical devices. It evaluates and evaluates the risks involved, how to control them, and how effectively it monitors the effectiveness of the controls.
ISO 14971:2007 applies to all stages of the medical device life cycle.
f. IEC 60601: Medical electrical equipment
IEC 60601 is a standard tribe whose latitude covers safety, basic performance, and compatibility of electromagnetic medical electrical equipment and systems. The tribe consists of more than 70 separate standards.
A medical electrical device is defined here as an electrical device that has an application component or transmits energy to or from a patient.
Part 1 standard IEC 60601-1 covers the basic safety and performance of all medical electrical equipment. For example, electromagnetic compatibility (IEC 60601-1-2) or X-ray diagnostic protection (IEC 60601-1-3) are part of this section.
Part 2 standard, IEC 60601-2 is a “specific” standard for specific measurements built into a particular product group or product. For example MR scanners (IEC 60601-2-33) or electro-encephalograms (IEC 60601-2-26). Collateral and specific standards may have their own revisions, unlike general standards.
g. FDA 21 CFR Part 807
Central Equipment and Radiological Health (CDRH) is a subset of the FDA that oversees companies that manufacture, repack, relabel and/or import medical devices sold in the United States. In addition, CDRH also manages the emission of radiation from electronic products (medical and non-medical), such as lasers, X-ray systems, ultrasonic equipment, microwave ovens and color televisions.
List of Medical Devices – 21CFR Part 807
This FDA list requires all types of manufacturers, distributors, repackers, re-processors, specification developers, and processors – using equipment, importers and exporters to register their organizations with the FDA.
h. FCC Title 47
Chapter 47 of the Federal Regulations (CFR) refers to the rules and regulations of the FCC.
This defines the Electromagnetic Interference (EMI) standard for electronic device certification. It certifies any electronic device that contains or RF equipment. RF devices can be defined as devices capable of emitting energy in the frequency range of 9kHz-3000GHz.PS: Your medical device may be subject to other specific regulations and may contain other specific standards.
In addition to standards, there are a number of key factors that can regulate the success of medical circuit boards.
4. The most important point is the security of the device.
a. Accuracy is an important factor, as we mentioned earlier, signal integrity, more interconnection, and the placement of lead-free components all play a role. the main role.
b. Reliability and predictability are as important as precision. Importantly, the device works repeatedly for the same condition, condition, or stimulus, but during the life of the device. To ensure this, your design must be reasonable, but your CM must use high-quality components and materials.
5. Ease of use or availability is another important factor.
To maximize your chances of successfully developing medical devices, you must maintain a delicate balance between capability and availability.
Speaking of regulations, compliance, and standards after so much, let’s take a look at some interesting developments in the healthcare PCB.
We’ve already mentioned electronics in our article, and now we’re going to talk about sensitive human senses. Technology has long played an important role in audio-visual hearing aids. But there are other senses that require our attention, following ongoing research and research to form perceptive skin. It is an extrusive, sturdy “skin” that is essentially a printed circuit with thousands of transistors. Although it’s still in its infancy, we can expect Stanford to come up with results soon.
Ingestible sensors for digestive diagnosis can diagnose different gases in the stomach. The device is about the size of a large oval vitamin capsule and is swallowed only by the patient. This is considered a diagnostic tool for many stomach-related problems.
Sierra Circuits’ final comment
Evolutionary history tells us that sometimes revolution is the only way, and almost inevitable. Like the healthcare industry, this area is progressive and steep. In today’s information entangled in our lives, an assumption is never an option. Therefore, symptom-based diagnosis can sometimes be misleading, and proper testing equipment makes it a guaranteed problem.
Medical multi-PCB has almost eliminated what we call the miscalculation of medical conditions. It has changed the way we live and die. This humanitarian leap has become possible because dedicated doctors and healthcare industry-related personnel, as well as all those PCB designers, manufacturers, assemblers, suppliers, distributors, etc., have been working to improve their lives. Strive to build a perfect world with all kinds of health facilities.
- Disease prevention
- Diagnosis of injury or disability
- Research, substitution, and regulation of anatomical or physiological processes;
- Pregnancy surveillance
- Medical imaging
- Biomedical signal
- Medical Laboratory
- Medical information
- Disease diagnosis
- Intelligent Medical Engineering
- Medical Intelligence Perception
- Medical Big Data Analysis
- Medical Intelligent Decision Making
- Precision medicine
- Medical Intelligent Human-Computer Interaction
- Intelligent medical instrument
- Intelligent Telemedicine
- Medical education
- Intelligent Medical Image Analysis
- Intelligent diagnosis and treatment
- Intelligent surgery
- Precision radiotherapy
- Neural engineering
- Rehabilitation engineering
- Tissue engineering
- Application of Gene Engineering in Medical Related Fields