What Standards and Regulations utilize for Medical PCB Assembly?

By | Date posted: | Last updated: May 21, 2021
Medical PCB Assembly

The use of Printed Circuit Boards has been ubiquitous across industries. Like with other industries, PCBs are also finding extensive application in the medical industry as more and more medical research and treatment methods become technology driven. With lives of patients at stake, it goes without saying that these devices are mission critical and that stringent guidelines need to be followed when it comes to Medical PCB Prototype. Clearly there cannot be an instance where there is a malfunctioning instrument when a critical, lifesaving medical procedure is being carried out. Little surprise then that these instruments need to be manufactured to some very exacting standards.

There need to be strong protocols related to PCB design, fabrication, PCB assembly, testing and inspection. Even though medical devices are varied, and their use is widespread across functions and there need to be specific standards and regulations related to their use, here is a quick overview of the broad Medical PCB Assembly Standards and Regulations:

IPC Standards

Presently called Association Connecting Electronics, its acronym comes from its former name i.e. Institute for Printed Circuits. It is an industry body that has issued a series of standards for circuit boards. These include:

medical-pcb
IPC-A-600: This is to do with acceptability of the circuit boards.
medical-grade-circuit-board
IPC-A-6012: This deals with the performance specifications for PCBs.
medical-printed-circuit-boards
IPC-A-610: This standard is to do with acceptability of electronic assemblies. Under this, there are different standards for:

  • Harnesses
  • Soldering
  • Enclosures
  • Cables
pcb-assembly
ISO 9000: A commonly known standard, it stands for International Organization for Standardization. There are several standards under this series that are to do with quality of circuit board design, its manufacturing as well as testing. Usually, a CM is certified in one of the ISO 9000 standards, with ISO 9001 being the most common.
medical-pcb-manufacturer
FDA: 21 CFR 820, introduced by the U.S. Food and Drug Administration is a quality system regulation, whereby with the relevant certification the medical device OEMs need to carry out their manufacturing and control processes. This then ensures that their product meets the necessary requirements.

ISO 13485: QMS for Building Medical PCBs

medical-grade-pcb
This is another very important standard for circuit board manufacturers. Aligned to the ISO 9000 series, this standard specifies the quality and reliability of medical products. Under this standard, the specific criterion for the manufacturer to put a documentation process and track materials is laid out. Some of the important aspects of ISO 13485 include:
  • The certification requires that all manufacturing phases are clearly documented so that products are built as per regulation
  • It also ensures that processes are in place for risk management and design control.
  • Manufacturers are also required to develop an audit system to track their own performance as far as the process goes.
  • ISO 13485 certification also means that the contract manufacturer is aware and promotes the other regulatory requirements. By doing this, it is a given that the requirement of regulatory bodies is met with.

With these standards in place, it is an assurance to regulators as well as to clients that the manufacturer is fully committed to quality and that it has the necessary systems as well as processes in place.

This of course, means that in order that your medical requirement meets the necessary regulatory standards, you need to partner with a contract manufacturer who works with these standards. If you have been looking for a contract manufacturer that offers Medical PCB Prototype that adheres to the highest standards, your search ends at Technotronix. Not only are we certified to the highest industry standards, but we also have a highly trained team that has the requisite experience and expertise when it comes to Medical Printed Circuit Board Assembly. The fact that we are also equipped with industry best practices ensures you do not need to reinvent the wheel. When you partner with us, you can rest assured that you will get medical equipment that stands tall against the exacting requirements.

TechnoTronix excels in providing solutions to medical mechanism. We offer medical electronic solutions to injection Molding and packaging and complete product manufacturing per layout. With over 4 decades of industry experience and rich knowledge to boot, little surprise then that Technotronix has emerged as a preferred partner of choice across industries including the Medical Printed Circuit Board Assembly.

Request a quick quote for Medical PCB Assembly

Top Considerations while selecting Cable and Wire Harness Assembly to enhance the performance of your final product!

By | Date posted: | Last updated: April 8, 2022
cable-and-wire-harness-assembly

Do you know what is the key component of any electronic or electrical systems? It is a cable and wire harness but unfortunately, many treat it as an afterthought. While you design your systems, cable and wire harness assembly should be the first thing to be considered in the design phase. Various components are required in cable harness assembly and each component affects the performance of the cable and wire harness assembly.

In the cable and wire harness assembly, either over-design or under-design will have negative impacts on the performance of the finished assembly.

Environment

The first thing you need to think of is the environment in which the assembly is going to be used. If it is going to be used in a dynamic installation or a harsh environment, you should be aware that it will be exposed to flexing, and your components of the cable and wire harness assembly should be able to withstand the flex. If it is going to be used in a cleanroom environment, make sure the assembly can withstand the sunlight and moisture.

Materials

Use the best materials for meeting the expectations of the assembly installation, for signal transmission over the assembly, and safety certifications that comply with the environment.

Conductors – Based on the application, the number and type of conductors to be included will be determined. There are different options for the conductive material and the most widely used one is copper. Copper retards corrosion and you can also go for copper-clad steel or copper alloys if you want to add strength. You can also use copper along with tin for various coatings. Silver or nickel coatings are used for letting the cable assembly be used in environments of high temperatures. They can be used as a single solid strand or many smaller conductors as they can help in overcoming the rigidity of the wires and make them more flexible.

Primary Insulations – The material, type, and thickness of the insulator of the primary conductors depend on the application where the custom cable assembly is used. Depending on the temperature the assembly will be exposed to, the voltage levels, the type, chemicals the assembly will be subjected to, and how harsh the environments will be, you should choose the appropriate materials. If your assembly needs to work at extreme temperatures, you need more rugged compounds for proper functioning. You may also have to foam them for higher-speed signals.

Cable Type

Different applications require different cable types. For instance, a coaxial cable is used for RF applications, shielded cable for noise-sensitive applications, ribbon cable for insulation displacement contact, and simple equipment wires for simple applications. The conductor wires must be sized properly to ensure that the current and voltage drops are acceptable in all operating conditions.

Cabling of conductors

When pairs of the same cable are in close proximity, the most common problem is the noise. So you can go for twisting of the pairs of cables for countering the effect. The conductors should be cabled or twisted for reducing the noise in the transmission of the signals. It is also aesthetically pleasing.

Shielding

With several shield options, you can go for metallize foil that has fairly good flexibility and is good at higher frequencies. You can go for a braided shield where there are many small diameter wires braided onto the cable core using special equipment. Although this is costlier than a foil shield, it offers better shielding at lower frequencies and offers better flex life. We also have a spiral shield that offers excellent flexibility with long flex life. You can go for a combination of foil and braid shields which offer excellent protection at all frequencies.

Outer Sheath

After finishing the cable core construction, an outer sheath is applied that acts as a protective covering. This outer sheath has to be tough for protecting the cable from harsh environments and be flexible for allowing the movement of the assembly throughout the life cycle of the equipment. It has to be chemically resistant and also be semi-conductive. PVC is the most widely used compound and other materials include urethane-based products, elastomer-based products, fluorocarbons, and other alloys that offer low-smoke, low acid generation, and low toxicity.

Connectors Reliefs

Among several options available for the cable assembly, you need to check the type and speed of the signal being transmitted. If a high-speed signal is to be transmitted, go for a solder type connection; if a power is to be sent through the assembly, a crimp type should be chosen.

Routing

Make strategic use of the cable space for avoiding sensitive parts of the system from being damaged. This also improves the effective use of cable assembly. Cable assemblies have to be routed close to the chassis in the systems where there are vibrations or movements. In high-vibration applications, you should consider including anti-wear measures like cable clips.

Safety Standards

Safety is one of the major concerns while designing a cable assembly and wire harness. The key element here is the location where the assembly will be used as the safety certifications and standards vary from a region to region. You need to make sure that the environmental standards are met by your assembly. The regulatory and safety standards that are meant for the enforcement and testing of electrical devices differ. In the USA, we have UL and CSA standards as the regulatory and safety standards. Also, RoHS directives are another environmental standard that limit the use of hazardous substances in electrical products.

Besides these, your cable assembly and wire harness assembly must also meet the industry standards based on the specific performance criteria.

Summary

You have to consider a lot many things while designing your cable assembly and wire harness for your application. Be clear about your specifications and design needs before you begin your assembly and manufacturing process. If you disregard any of the factors, the performance of your final product could be affected. We recommend you bring up all the specifications to your CM who has taken up your cable and wire harness assembly needs.

At Technotronix we have 40 years of experience in manufacturing and assembling industry leading products. Equipped with state-of-the-art equipment and skilled personnel we offer products to meet your bespoke requirements. Technotronix can be a trusted Cable Assembly Manufacturer partner for you, which will give you ample smart solutions related to Printed Circuit Boards.

Surface Mount vs Through Hole – Which one is the best for your next project?

By | Date posted: | Last updated: February 14, 2022
surface-mount-vs-through-hole

Today, all modern electronic devices contain printed circuit boards (PCB) on which various electronic components like capacitors, resistors, integrated circuits, transformers, and so on are connected. And there have been two primary methods for mounting these electrical components onto the PCBs – surface mount and through-hole.

There has been a never-ending debate over which type of components should be used – surface mount or through-hole. If you face are as puzzled as everyone else, you are at the right place. In this article, we cover some of the basic differences between SMT and through-hole and help you make the right choice for your next project.

What are SMT and through-hole technologies?

Initially, through-hole parts were the only known components that were prevailing when printed circuit boards came into production. With time, Surface Mount Technology (SMT) saw the light of the day and became popular. Now, it is the most dominant component type used in the PCBs.

In the surface mount technology (SMT) method, you mount the components directly on the surface of the PCB using a solder. And the majority of electronic hardware manufactured today has PCBs that are assembled using this SMT method.

In the through-hole method, you take a bare PCB and drill holes onto it. The leads of the components are inserted here. With the rise of surface mount technology assembly, this process may seem to be obsolete, but TMT has its own benefits and still relevant.

Manufacturing Differences

There are some notable manufacturing differences between SMT and through-hole components.

There are two ways for soldering components onto the printed circuit boards –

  • Wave solder
  • Solder reflows

Although not a hard-and-fast rule, but most of the SMT components are solder reflowed, while through-hole components are wave soldered. In the through-hole PCB assembly technique, even if the components are inserted into the holes that are drilled, the circuit boards are run through a wave soldering for forming a strong solder joint. Quite often, through-hole parts are manually inserted.

For SMT components, solder paste is directly applied to the pads keeping the leads of the components in one place. The solder paste reflows when the PCB runs through the specialized oven. Here, a solid solder joint is formed. If you are using a mixed type, then a mixture of both wave solder and solder reflow is required. There are automated pick-and-place machines that are readily available that can handle a variety of components in a reliable fashion.

Benefits of SMT and Through-hole

Let us understand why SMT component types are used frequently –

Size – SMT components or parts are small or miniature by default. There is no need for drilling down the holes. This looks clean and attractive especially in the age wherein electronics come with smaller board sizes.

Availability – Today, SMT has taken over the through-hole components. They are smaller and replaced the through-hole parts like resistors, capacitors, etc.

Performance – The use of smaller parts in SMT makes the electrical signals travel through a less distance. This reduces the signal flight time as well. Hence SMT components offer better electrical performance than through-hole components.

Cost-effective – SMT parts are usually less expensive than the through-hole counterparts.

Let’s quickly look into the benefits of through-hole parts as well.

Availability – If you need larger parts that are used in high-power applications, it may be difficult to find an SMT equivalent part. Through-hole parts are readily available.

Strength – If there is constant stress that the parts have to go through, SMT solder joints may break. In such cases, components like connectors, switches, and other interface parts need the strength that is effectively provided from the leads soldered into a drilled hole.

Power – SMT is not a good option for high power circuits as it is difficult for SMT soldering to achieve strong solder joint. Hence a through-hole technique offers a more robust mechanical strength for thermal, high voltage, and mechanical stability.

Other differences between SMT and through-hole

In SMT, more components can be mounted on the circuit board as the SMT components are smaller in size. Also, both sides of the board can be utilized. Space issues won’t be a problem which is usually the case in the through-hole process. You can have smaller and lighter designs that are powerful and faster through the SMT process.

If you wish to have high production volumes, then go for the SMT process as it offers a lower cost per unit.

Even the pin count or component lead count on SMT is large when compared to the through-hole process.

But SMT Printed circuit boards needs some heavy capital investment for setting up the machinery and production process. This is significantly larger than the through-hole process.
Also, the level of skill, design, technology, and production required for implementing the SMT is advanced than the through-hole.

SMT Or Through Hole?

At the outset with automated equipment, smaller size components, and cost-effectiveness, SMT components may seem to be the best choices for your printed circuit board designs. But don’t make such a mistake and jump to any conclusion. Both the component styles are equally important. These advantages do not imply the end of through-hole components.

Most of the integrated circuits go for the SMT package. However, for connectors, switches, or mechanical power parts, the standard way is to use through-hole parts. Also, legacy boards still use through-hole parts to fulfil your exact requirements. The robust through-hole parts are going to be of utility for a longer time.

Conclusion
A contest between surface mount vs through hole on the circuit board has been a long drawn one. There is no clear winner in this debate as each component type serves a different function and most of the time, the majority of the PCBs prefer a mixed type that involves both types. The key thing is to choose the right part for your specific project. The next important thing is to find the right PCB Assembly services. Technotronix has over 4 decades of experience and equipment to manufacture both types of component packages efficiently. We ensure the highest level of quality for your circuit board in both cases.

Get a Quick PCB Assembly Quote

How does the Mixed Model Assembly become a multi-objective to meet the growing industrial demand?

By | Date posted: | Last updated: April 27, 2021
Mixed Model Assembly

In one plate, Mixed model assembly provides the perfect balance of productive efficiency and flexibility of work. As the demand of the electronic market increases exponentially, a time-to-time updated device is very important to survive in the industry. A mixed model makes the assembly in such a strategy that it is simple to use but at the same time effective.

What is Mixed Model Assembly?

A mixed-model assembly is a union of some identical group product that shares a similar type of work as the content of the task, process of functioning, materials used in manufacturing, etc.

The main aim of developing is to handle the rush of markets. To tackle the rapid change of the electronic industry and make the device flexible to work according to situations.

Benefits of Mixed Model Assembly

The benefits are so prominent that they cannot be described in one sentence. It improves the widespread productiveness of the assembly. Some of the benefits are described in the following points below –

  • The time required for the manufacturing is very short. It works so rapidly that it seems like no time in the formation of the layout. This criterion is very important to catch the customer’s attention. Thus, mixed model assembly able to meet the client’s expectation promptly.
  • One of the other valuable benefits of this high-mix assembly is it is automated. It works automatically, so it lessens the manpower needed in manufacturing. Directory technology of mixed assembly optimizes every point of the manufacturing process. This technology-based voluntary process minimizes the error of the design format also.
  • Flexible – volume assembly system is very useful to cope up with the change in the environment. The flexibility of the system supports the assembly to work in a wide range of variations in circumstances.
  • The ultimate product form after the policing of every step is much more preferable than any simple manufacturing. There is no hazard found in stocking, delivering, packaging also, as it is also taken good care of by my mixed model manufacturer. It furthermore diminishes inventory also.

How the mixed assembly meets the demand of the industries?

  • Mixed assembly calculates the production strategy through detailed planning. To find the perfect strategy, sometimes administrators of the assembly do offshore and finalize the technique.
  • As the production of service in mixed assembly is wide, the secondary expenditure of manufacturing is cut out. So, the ultimate value of the assembly is far lower than any formal production. On the other hand, offshoring also minimizes the exposition cost by neglecting the mechanical error during production.
  • The layout serves by the assembly is according to the client’s demand. They accustom the model by client’s preference,
  • the products small in size, lightweight, so that it becomes handy to use. The manufacturer tries its very best to make the product manageable.
  • Advanced Technology of mixed model assembly reduces the labor required by replacing it with smart hardware and software. Different tools are used for each distinct purpose. That also good for lowering the man-made error percentage.

Guidelines for successful Mixed Model Assembly

Although the mixed-model assembly is very effective and efficient, some special management is needed to function the assembly properly. And to manage it in order, some proper guidelines need to follow. This guideline helps the assembly to work in a disciplinary manner. The guidelines are –

  • Every work has to be put on the record. That means proper documentation is needed in each step. This document functions as proof of your work. So, if any difficulty finds in the future, it can be reviewed from the document. This documentation standardized the assembly’s reputation.
  • Always recruit dedicated employees with high skills. Employees are the resources of the assembly’s good service delivery. So, make sure the worker of the assembly trained enough to do satisfactory work. If required, arranged some training program to give updated knowledge to the employee.
  • Assembly work is teamwork, so each member’s knowledge is equally important to any other production factors. Every team leader has to look keenly at the efficiency of each team member.
  • Time management is another factor to consider. List down the full schedule of work, and try to follow it strictly to avoid procrastination.
  • Also, make a sequence of the rule for working in order. Always try to provide the service at its given time. Some emergency is considerable, but if the assembly always delays delivering the product, the client loses their trust towards that particular assembly.
  • Always updated the service according to time and the market. The world is evolving every minute, and that means with it, all services also have to modify to stand up to your assembly in the market.

Know the market well, understand the competitor, their strong and weak point, and improve your service by doing all this analysis. Expanse the assigned line for the PCB assembly growth.

By maintaining these guidelines properly, a make-to-order environmentally produce. In this set number of works, the station becomes small, and the employee becomes highly skillful, which eventually makes the assembly updated.
It perfects the process by tree way- balancing the diagrammatic layouts, balancing every prototype, and balancing with the neighborhood searching process.

Conclusion:

Mixed model assembly is used by many important industrial productions now a days. Now with the market’s trend, brief time life cycle products become in-focus light. Formal mass-produced now become out of trend.

It works on the make-to-order strategy with lessened the leading time of the consumer. By this type of strategy, a range of different types of design can produce from one assembly line. So, it is time to rethink your assembly preference, and you want suggestions must try a mixed-model assembly line for the PCB design to sprout in the market. We provide advanced PCB prototypes, high and low volume PCB production, mixed assembly placement in addition to component sourcing, layout rework and destructive testing services to our customers worldwide.