In Search of High Reliability in Printed Board Fabrication for Medical Device Applications
By John Perry, Director of Printed Board Standards & Technology
Key Summary
• Medical device PCBs often exceed the reliability needs covered by traditional IPC Class 3 requirements
• Operating environments vary widely, making standard Class 3 criteria insufficient for many medical applications
• Large production volumes in medical devices challenge traditional IPC sampling approaches
• IPC is developing dedicated medical device addendums (IPC-6012DM and IPC-6013DM) to address these gaps
• A presentation at MD&M West highlights qualification issues, reliability needs, and planned medical-specific standards
• IPC is engaging OEMs, PCB designers, and quality teams to shape higher-reliability PCB requirements
It has been well known that for many years IPC has provided a trio of performance classifications in its suite of standards and specifications for the design, fabrication, assembly and acceptance of printed boards and printed board assemblies. Intended to reflect differences in producibility, complexity, functional performance requirements and verification through inspection and testing, IPC has given end users (OEMs) the authority to specify which IPC performance class the printed boards and assemblies must adhere to for their product. This model isn’t without its limitations, however. A printed board fabricated in accordance with Class 3 (high performance/harsh environment electronic products) requirements from IPC-6012D, Qualification and Performance Specification for Rigid Printed Boards (or the corresponding IPC-6013D for flexible and rigid-flexible printed boards) can be subjected to very different operating environments. A Class 3 printed board intended for usage in a space exploration vehicle on a one-way trip to Jupiter is going to experience a very different set of thermal cycles compared to a printed board utilized in an automotive under-the-hood application. The same can be said for exposure to vibration for a printed board utilized in an oil-drilling operation compared with that of a marine application. Understanding this, IPC has already published a set of addendums to some of its most widely used standards for specific industry segments, including space and military avionics and automotive, where exceptions have been made to the baseline IPC Class 3 requirement in the parent standard or specification. Never has a case for this approach, however, been more evident than with respect to printed boards utilized in medical device applications. Will the “traditional” IPC Class 3 performance class be sufficient for printed boards used in applications where interruptions to service may result in the loss of life or permanent bodily harm to a patient or equipment operator? If an exception to an IPC Class 3 performance attribute were developed for medical device product, would that exception need to be further sub-divided between “standard” sized printed boards utilized in diagnostic or patient monitoring equipment (e.g. electrocardiograph or blood analyzer) and “micro-PCBs” utilized in implantable devices (e.g. neurostimulator or gastric stimulator)? Sampling frequencies of production printed boards or test coupons within an overall production “lot” for IPC Class 3 product have traditionally been based on the needs of defense products in ground, airborne or space applications where production lots are relatively small. These traditional IPC sampling frequencies for production lot acceptance, however, fall apart when dealing with production runs in the thousands or tens of thousands of printed boards, as in the case of medical device product. Recognizing all of this, key members of a new IPC task group will be giving a presentation at the Medical Design and Manufacturing (MD&M) West Expo in Anaheim, Calif. on Tuesday, February 6, 2018, titled “Do you Really Know if Your Medical Device PCBs Comply with Required Qualification Standards?” Located in the Tech Theater on the show floor of the Anaheim Convention Center and scheduled for 10:30 AM local time, the presentation will address: • Medical and Biological Innovations Across the Decades • Present Day Medical Device Electronics • Density Trends in Array Packaging for Medical Device Electronics • The Cost of Quality of Electronic Failures to Major Medical Device Manufacturers • Existing Standards for Medical Device Electronics and the Gap in Conformance Assessment for Printed Boards • Intended Scope for IPC-6012 and IPC-6013 Medical Device Addendums If you are attending or plan to attend the MD&M West event, IPC encourages those of you involved in printed board manufacturing and procurement to attend this session and learn how we are pulling together OEMs, PCB design engineers and quality engineers and managers at the PCB fabrication level to help put together the new IPC-6012DM and IPC-6013DM Medical Device Addendums to our printed board qualification and performance specifications for rigid, flexible and rigid-flexible printed boards. Please note that while members of this IPC task group are presenting at MD&M West, IPC is neither sponsoring nor directly involved with this event, and therefore IPC membership has no bearing on registration costs for this event under UBM Management. For additional information on the IPC-6012DM and IPC-6013DM Medical Device Addendum efforts, please contact me, at JohnPerry@ipc.org or +1-847-597-2818.
Class 3 was built for harsh-environment electronics, but medical devices require even higher reliability, especially where failures could risk patient safety.
Medical production volumes can reach thousands of boards, making traditional Class 3 sampling methods impractical for ensuring consistent reliability.
Both large diagnostic systems and micro-PCBs used in implantable devices demand tailored reliability criteria beyond standard Class
IPC is creating IPC-6012DM and IPC-6013DM addendums to address qualification and performance needs specific to rigid, flexible, and rigid-flex medical PCBs.
IPC encouraged attendance at the MD&M West session covering qualification gaps, density trends, and the scope of upcoming medical device addendums.
IPC E-Textiles Standards Committee Seeks Comments on Draft of New E-Textiles Standard; Participants Needed to Join Subcommittee to Develop E-Textiles Connectors Guideline
By Chris Jorgensen, director, technology transfer The IPC E-Textiles Materials Subcommittee is collecting comments on the first sections of IPC-4931, Requirements for Electronic Textiles (E-Textiles), Conductive Fibers and Conductive Yarns. This standard will establish the classification system, qualification and quality conformance requirements and electrical/electronic performance requirements for electronically integrated textiles (e-textiles). It also covers similar requirements and performance variables for conductive fibers and conductive yarns, that are essential components of e-textiles. E-textiles included in this standard: • Woven textiles • Knitted textiles • Nonwoven textiles • Laminated textiles • Braided textiles • Embroidered textiles • Printed textiles The subcommittee specifically seeks comments on the first sections of the standard. These sections are important because they lay out the specific types of textiles and their components that the standard will cover. Additionally, the group wants industry input on the key performance characteristics the standard should include for these materials as well as the industry test methods that should be used to test for these characteristics. The subcommittee is collecting comments through Friday, February 16, and commenting is open to anyone. You do not need to be a member of IPC or to pay any fees to review and comment. E-mail me, at ChrisJorgensen@ipc.org to request the documents for comment and an IPC comment form. Subcommittee Meeting to Discuss Comments You are invited to attend the IPC D-72 E-Textiles Materials Subcommittee meeting, which will take place Thursday, March 1 during IPC APEX EXPO in San Diego. The specific start and end times for the meeting have not been set yet, but plan on a full-day session. There is no cost to attend the meeting if you register ahead of time. Visit http://www.ipcapexexpo.org for more information. New Subcommittee Forming to Develop Guideline for E-Textiles Connectors Several companies in the e-textiles industry have approached IPC with interest in developing a guideline on e-textiles connections. This is a very new activity, but based on interest, IPC should be forming a subcommittee to break ground on this new document in early 2018. If you have interest in this topic and would like to join the subcommittee roster, e-mail me at ChrisJorgensen@ipc.org. Mark Your Calendar for IPC E-Textiles 2018 Mark your calendar for September 13, 2018. IPC E-Textiles 2018 will bring together the e-textiles supply chain for a full day of technical presentations, hands-on product demonstrations and networking. Don’t miss this opportunity to learn from and interact with innovators from the e-textiles community. Plan to arrive a day early for standards meetings on September 12. For more information on IPC E-Textiles 2018, or if you have interest in speaking or showcasing your products, e-mail me at ChrisJorgensen@ipc.org.
Reduce Pollution of Process Gasses in an Air Reflow Oven
The introduction of lead-free solders resulted in a selection of different chemistries for solder pastes. The higher melting points of lead-free alloys required thermal heat resistant rosin systems and activators that are active at elevated temperatures. As a result,more frequent maintenance of the filtration systems is required and machine downtime is increased. Last year a different method of cleaning reflow ovens was introduced. Instead of cooling down the process gasses to condensate the residues,a catalyst was used to maintain the clean oven. Catalytic thermal oxidation of residues in the nitrogen atmosphere resulted in cleaner heating zones. The residues were transformed into carbon dioxide. This remaining small amount of char was collected in the catalyst. In air ovens the catalyst was not seen as a beneficial option because the air extracted out of the oven was immediately exhausted into the environment. When a catalyst is used in an air environment there is not only the carbon dioxide residues,but also water. When a catalyst is used in an air reflow oven the question is where the water is going to. Will it condensate in the process part of the oven or is the gas temperature high enough to keep it out of the process area? A major benefit of using a catalyst to clean the air before it is exhausted into the environment is that the air pollution is reduced dramatically. This will make environmental engineers happy and result in less pollution of our nature. Apart from this,the exhaust tubes remain clean which reduces the maintenance of air ovens. This paper will give more detailed information of catalyst systems during development and performance in production lines.
Void Reduction in Bottom Terminated Components Using Vacuum Assisted Reflow
Pockets of gas,or voids,trapped in the solder interface between discrete power management devices and circuit assemblies are,unfortunately,excellent insulators,or barriers to thermal conductivity. This resistance to heat flow reduces the electrical efficiency of these devices,reducing battery life and expected functional life time of electronic assemblies. There is also a corresponding increase in current density (as the area for current conduction is reduced) that generates additional heat,further leading to performance degradation. This paper will describe the results of a series of experiments performed in an in-line convection reflow oven,using a typical lead free reflow profile,with three types of bottom terminated components commonly used in power management applications. A solder paste flux and alloy with a known high level of voiding was used as the control. This solder alloy is of unique interest,despite its voiding in ambient reflow conditions,as it has shown superior resistance to failure under automotive thermal cycling conditions (-40C to +125C) and vibration. The experimental design was comprised of two levels of vacuum (5 and 20 torr) applied at two levels of time (30 seconds and 60 seconds) while the test assemblies were at or above the liquidus temperature of the lead free solder alloy. Each 2 x 2 factorial was performed on identical printed circuit boards with four (4) different substrate surface finishes,including Immersion silver,Immersion tin,ENIG (Electroless nickel,Immersion gold) and an Organic Solder Preservative (OSP) finish used. Each condition was repeated three times and three controls with no vacuum were also processed for each surface finish. Therefore,a total of 60 component/substrate samples were processed and subsequently examined for voiding using X-ray analysis. The results of this study indicate that the vacuum pressure,time under vacuum and the surface finish have little effect on the results when vacuum reflow is utilized. The use of a low pressure vacuum when the solder alloy is in liquidus conclusively results in a significant reduction of observable voids in each combination of surface finish and reflow process condition.
Dissolution in Service of the Copper Substrate of Solder Joints
It is well known that during service the layer of Cu6Sn5 intermetallic at the interface between the solder and a Cu substrate grows but the usual concern has been that if this layer gets too thick it will be the brittleness of this intermetallic that will compromise the reliability of the joint,particularly in impact loading. There is another level of concern when the Cu-rich Cu3Sn phase starts to develop at the Cu6Sn5/Cu interface and an imbalance in the diffusion of atomic species,Sn and Cu,across that interface results in the formation at the Cu3Sn/Cu interface of Kirkendall voids,which can also compromise reliability in impact loading. However,when,as is the case in some microelectronics,the copper substrate is thin in relation to the volume of solder in the joint an overriding concern is that all of the Cu will be consumed by reaction with Sn to form these intermetallics. This paper reports an investigation into the kinetics of the growth of the interfacial intermetallic,and the consequent reduction in the thickness of the Cu substrate in solder joints made with three alloys,Sn-3.0Ag-0.5Cu,Sn-0.7Cu-0.05Ni and Sn-1.5Bi-0.7Cu-0.05Ni. A simple model developed for the reduction of the Cu thickness as a result of the diffusion controlled reaction with Sn to form Cu6Sn5 was found to fit the experimental data well. The results reported in this paper provide an example of the way in which microstructural features that can affect joint reliability are affected by small alloying additions.
Voiding Performance with Solder Pastes Containing Modified SAC Alloys for Automotive Applications in Bottom Terminated Component Assemblies
Voiding is a key concern for components with thermal planes because interruptions in Z-axis continuity of the solder joint will hinder thermal transfer. When assembling components with solder paste,there is a high propensity for voiding due to the confined nature of the solder paste deposits under the component. Once reflowed,many factors contribute to the amount of voiding in a solder joint such as the reflow profile,designs of the component,board and stencil,and material factors. This study will focus on the solder paste alloy and flux combination as well as profile and board surface finishes. Several alloys have been developed in the last decade to boost performance in high-temperature environments and reliability in thermal cycling tests. These alloys typically consist of SnAgCu with additional elements such as Sb and Bi to modify performance. One of the key barriers to adoption of these alloys has been higher levels of voiding. Previous papers have explored the effect of process and stencil modifications with one or more of these alloys1. The solder pastes include several alloys within the range of compositions suggested for automotive applications in combination with different paste fluxes. The results will compare voiding with various alloys and common board surface finishes.
Investigation of Characteristics of Lead-Free Powders for Solder Paste Application
Solder paste has been used in the surface mount technology for many years. However,a complete understanding of the effect of key powder characteristics on the paste properties is still not achieved. This understanding becomes much more important when new solder pastes with finer powder size are developed for advanced applications. In addition,the effect of other parameters such as time,humidity and temperature may also influence the performance of pastes made with fine and ultra-fine powders. In this work,the influence of key powder characteristics on the reflow property of paste made with powders produced with a proprietary atomizing technology,particularly effective in producing solder powder ranging from 1 to 25 µm,is presented and discussed. Powder characteristics considered are particle size distribution and oxygen content. SAC305 powder were aged at various humidity/temperature conditions. The reflow performance of the pastes made with aged powder was evaluated. Moreover,the oxide layer formed at the powder surface was characterized using Auger Electron Spectroscopy and Transmission Electron Microscopy. The influence of external parameters such as humidity and temperature on the powder is discussed.
Moisture Diffusion Modeling of a Thin Film Acrylic Resin Based Conformal Coating on PCBA
High reliability process automation devices require serious protection from harsh environments which can be a combination of moisture,corrosive gases and liquids,salt sprays,large temperature variations,mechanical vibration and fungus. Conformal coatings of various resins provide such range of protection for electronics circuit boards. High levels of residual moisture accumulation in electronics can result in malfunction which can be a serious safety issue. This paper discusses the analytical modelling of moisture diffusion and ingress rate through an Acrylic conformal coating,which is a good choice for addressing corrosive environments use,validated by FEA simulation. Diffusivity of materials is determined experimentally using IPC-TM-650 Method 2.6.28. In comparison,a silicone resin based coating is also considered in the study. Mathematical equations have been developed for the calculation of the characteristic times of moisture diffusion in the Acrylic resin based conformal coating of different shapes and sizes to address topography issues. An argument is presented for use of adequate bake-out schedules for different situations which can be calculated based on the temperature dependency of the moisture diffusion coefficient of polymer materials. The diffusion coefficient of the Acrylic conformal coating was experimentally determined using absorption data by weight gain experiment. Once the diffusivity coefficient is known,a theoretical fickian curve is plotted with the experimental data to confirm agreement of its behavior with the fickian curve. The 99% saturation approach is also used which helps to define the limit of fickian diffusion hence eliminate error caused by non-fickian absorption. In comparison to thick films,thin film layers are thin enough that time to reach equilibrium concentration is relatively short and subsequent transport rates are governed by the diffusion behavior of the saturated film. Several moisture concentration curves were created based on the different compound,size and shape of the coating to understand the variation of moisture concentrations. Finally,based on results and understanding of moisture ingress rate through Acrylic and silicone conformal coating material and considering deployment designed life of the product,proper selection of materials together in conjunction with proper bake-out cycles can be used or created specifically for the products to increase the reliability of the product in the field.
UV Broad Spectrum & LED Curable 100% Solids Very Low Viscosity Conformal Coating
Very low viscosity formulations are often required for very thin conformal coating applications. Solvents are used to reduce viscosity of the formulations and accommodate dispensing needs. Solvent-free coatings are attractive due to their environmental friendliness and ability to allow faster processing for coating lines. Until recently,efforts in developing very low viscosity 100% solids coatings were not successful due to performance requirements such as chemical,heat,and humidity resistance. We have developed a technology that results in 20-30 cP viscosity 100% solids UV curable coatings. We will discuss the performance in reliability tests such as heat and humidity resistance (500 hours at 85 oC / 85 % relative humidity) and corrosion resistance (flowers of sulfur resistance and salt spray resistance). Any change in physical appearance,formation of oxidation spots,and insulation performance were checked after reliability tests. The new coatings can also be cured with long wave length LED light and secondary heat.