The Printed circuit board has evolved in several ways since its inception. Its influence cuts through many industries including the medical sector. PCBs are crucial in modern day devices. Its development became noticeable where technology drives and impacts our living.
Basically, PCB maintains the base for physical connections between electrical and electronic components. Circuit boards are present in every electrical, computer, mobile and many more devices. Also printed circuit boards are crucial to the medical field. Furthermore, modern medical devices operate efficiently using the PCBs as base components.
Also, with the advancement in technology, medical devices have become computerized. Thus, diagnostic and treatment practices depend on printed circuit boards. The delivery of medical services becomes easy and pleasant using modern medical gadgets.
Presently, the medical electronic device manufacturing industry is meeting up with stiff competition. This cuts across all levels of marketing. However, the response of the industry has been positive. This led to a high degree of transformation. Technological advancements in product design and manufacturing have moved healthcare to the next level.
The medical industry requires high precision and quality PCBs to meet their demands. Medical PCBs are dominant in the medical field. This article will touch in details the meaning of medical PCBs, and medical PCB assembly. Also, it will discuss the standards and controls for designing medical devices. Furthermore, the design process of the medical PCB assembly will be an area of discussion as well.
Medical PCBs Explained
Medical PCBs are the type of circuit boards designed solely for medical facilities. The PCB has broadened its usefulness and impact due to the growth in the technological world. Presently, PCBs have reduced the gaps between the players in the healthcare industry.
The change in the medical space has made the delivery of health care services efficient. Numerous critical health challenges are easily diagnosed and treated. Also patients’ health status could be adequately monitored. The development of handy medical devices also aids service delivery.
The medical field is an extremely sensitive industry. Therefore its facilities and equipment should deliver accuracy and precision. Also, to determine a properly diagnosed condition, accuracy of the medical device is crucial.
Thus, the high demand on the equipment used is because they deal with human lives. PCBA requires extra attention to deliver medical PCBs that are reliable and durable. Also, high density and miniature PCBs are the preferred PCB design. They are well embraced by the medical industry.
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Medical PCB Assembly Explained
The Medical PCB assembly technology has remodeled our world in various ways. It has its most significant impact in the medical industry. Diagnosis being the most essential phase with the aid of electronic equipment. There are varying machines in the market in relation to the medical industry.
Ultrasound, MRI’s, medical imagery and CT scanners are few of the equipment. It also includes monitoring, life support therapeutic and laboratory treatment devices. To produce quality standard products for the medical field, specific procedures are crucial.
The medical PCBA production steps are in the following order:
Concept design, research, printed circuit design, and packaging. They also include prototyping, design review, manufacturing setup and quality assurance. PCBA means printed circuit board assembly. The components attached to the board is the reason for calling it an assembly.
Also, the medical PCB assembly is a uniquely designed PCB for medically linked equipment. Its assembly and design entails so many perquisites. To produce a medical PCB assembly of standard, the following pointers are crucial
The assembly of medical devices might be open to liquids. They might also be open to shock, and extreme temperatures. Medical equipment lives on the human body, thus any malfunction could result in danger. It could also lead to liability if the result is traceable to ignorance. Therefore the medical industry requires highly reliable electronic medical designs. This is to deliver safe medical services.
Safety first also centers attention on cleanliness. Furthermore, medical equipment should be easy to disinfect and clean. Stainless steel is the preferred choice for cleaning medical devices. Also, this is because of its ease to clean feature. Furthermore, conformal coating could be an option as well. It is best at protecting medical devices against:
- Salt spray
Medical equipment and gadgets are class 3 electronics. Their requirements are to meet specific standard production. Also, keeping records is a necessity in the medical industry. Lot tracking of elements are important in the medical industry. ISO and FDA standards could be part of the standard.
Installation, and operational qualifications are sets of requirements in medical PCB assembly. Process qualification is an added set of requirements. Also, the qualification of the general equipment assembly might also be crucial.
It is important to note that components could go obsolete. Thus, a good medical PCB assembly producer should be able to predict the obsolescence of devices. Component database software will be a useful tool. Also, if a medical device component goes obsolete, it might have delayed approval for renewal. The delay most times is from agencies and it could lead to loss of life.
Medical PCBs Assembly Standards and Controls
The medical PCBs are developing into a standard necessity all through the industry. They are crucial to diagnose and cure ailments for health’s improvement. Therefore, it is vital to put in place strict standards for accuracy and patient safety. Medical devices vary and they are present in several sectors.
To produce quality outcomes and prevent device call backs, the PCB assembly rules must be strictly followed. These design standards regulate the inspection, production, tracking, and testing of the PCBs. Therefore, all medical devices require unique standards and controls.
Medical devices and equipment pass through tougher rules and controls than normal electronics. This is crucial because the failure of a medical device to function perfectly might cause disastrous impacts. Thus, each step of the production process goes through a mandatory oversight. This will ensure high quality and accurate end products.
The medical electronics pass through a quality management system. This is to find out and remove errors. Testing regiments confirm the standards’ compliance.
Factors to consider for Designing Medical Electronics Devices
The first deliberation to designing medical electronic devices is precision and accuracy. The performance or safety of the device is not a concern provided it meets standard accuracy. Meanwhile, if precision is safety or performance related, it should be carefully considered.
Precision answers to various questions. Questions on the level of precision required. Also what happens if it does not meet the required accuracy standard? Furthermore, it asks questions on ways to confirm accuracy over a period of time. It also answers to what happens to precision when used continuously or when dropped.
How to verify the accuracy gauge of medical electronics. This is another question precision asks. The above are some of the numerous questions designers must ask. This is to ascertain the precision level of the medical electronic devices.
Lifespan is a crucial determinant for accuracy and longevity of medical gadgets. In a perfectly designed device, the mechanisms are mostly prone to failure. It implies they determine the expected lifespan and maintenance timing for the device.
Therefore, it is crucial to consider the effect of repairs and replacement. It is a parameter in choosing a machine with small reliability. It is necessary to plan maintenance ahead with a suitable service provider. Its maintenance should enable high performance of the medical equipment throughout its lifespan.
Prior knowledge to the travel limit, and accuracy will help fabricate quality design. The result of going beyond limits will also enhance fabricating an-inclusive design. If the method is not manually activated, switches and encoders will transfer information.The information transferred will go at a high level of accuracy.
In the medical world, the failure or success of these sensors would create a huge impact on safety of the device. IEC 60601 specifies that the devices should be single-failure safe. This implies that their failure must be carefully analyzed and unforeseen reviewed.
In countless cases, some sensors might be inactive. It might as well initiate a hard stop to sensor failures. Also, applying a highly reliable sensor with inbuilt caution to reduce unforeseen failure.
If a user puts in a specific mechanism, there will be pinching or crushing hazards. Being a medical electronic manufacturer, the risks should be properly halted. Considering the IEC 60601-01 standard that outlines the emergency stops feature is vital.
Some medical devices create debris when in touch with other surfaces. Wastes like oil, gear, dust and chopped human hair can hamper biological tests. This hindrance could lead to inaccuracies. Oil and dust waste could interfere with the functionality of the device.
Thus, the effect of debris on medical devices should be well known to end-users. High performance and prolonged lifespan of the medical devices depend on its maintenance.
Always take note of the marginal cases in the medical devices. Likely causes of safety challenges include interruption when it is active. Temperature conditions and bumping are also inclusive. Therefore, the highlights are reliable causes of safety issues. If not attended to could lead to problems.
The usability of the medical PCB device requires consideration. This could boost its performance. An inferior design will automatically experience failure in validation usability. Thus, the needed amount of energy required to run the device.
It is advisable to invest quality time in the usability of the device. This will guarantee end-users effortless and satisfied experience and market approval.
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Assembling Process of Medical PCB
Assembling the medical PCB comes after the designing and fabrication of the PCB. Some crucial factors need consideration before the assembling process begins. These factors include the type of PCB, the features of the PCB parts, and the board’s function. The assembling process also requires some important tools to aid the process.
Few of these tools include soldering machine, solder paste, and solder wire. Other crucial tools include SMT equipment and testing equipment. The sensitivity of the medical field makes it important to conduct a design for productivity tests. This test is necessary to find out and correct any faults on the PCB design before assembling.
Design manufacturability test aims to ensure that the final board functions to requirements. The assembling process of the medical PCB are as follows:
Solder Paste Stenciling
The solder paste stenciling is the first of the assembling process for a medical PCB. It is the process where a stencil covers the board to a certain level. The part left uncovered by the stencil is for component mounting. This will aid in applying solder paste to places designed for components mounting.
For solder paste stenciling, the solder stencil and the board are mechanical held. The applicator aids in spreading the solder paste to designated places on the board.
Pick and Place
The pick and place process deals with the placements of the medical PCB components. To deliver high accuracy assembling of medical PCB, a robotic gadget serves right. Components picked by the robotic device on the surface mount are well placed on the board. Components are rightly placed on solder paste.
Ensuring solid joints between the board and electronic components require soldering overflow. This process explains the movement of the board through a large reflow oven. The conveyor belt aids the movement. Melting of the solder paste occurs when the PCB goes through a heat process of about 2500°C.
Medical PCB passes through coolers to firm up the solder paste. Therefore, it forms very strong joints between the joint and the board.
Inspection and Quality Control
Inspection of the assembled Medical PCB is extremely crucial. This assembling process helps to find flaws and correct them. It also corrects connecting flaws that might arise during the reflow movements. Many of the checks are on the board. They include x-ray inspection, manual checks, and automatic optical inspection.
Last Inspection and Functionality Test
The final step in the assembling process is the inspection and testing of the designed board. In this process, performance of functionality test to ensure the board works comes up. Meeting the required high medical standard is a need for inspection and testing.
Medical PCBs Applications
There are several applications in the medical industry. Few of these applications include:
- Scientific instrumentation
- Internal medical devices
- Control systems
- Scanning technology
- Wireless communication
Medical PCBs are designed for specific medical equipment and machines. Thus it requires extra steps to the normal electronic design. Its uniqueness in the design process is due its end-products as devices used to save lives. Thus, precision and accuracy is the strongest pillar for their products.