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12-Lead Clinical ECG Design Open Sourced; Supports Tablets, Too

Posted by timothy on from the every-home-could-have-one dept.

New submitter isza writes "MobilECG is probably the first open source clinical-grade electrocardiograph with simultaneous 12-lead recording and Android support. It has been designed to meet all the relevant medical standards (ISO 60601-1, etc.). Manufacturing cost @ 1000 pieces: ~$110. I had worked at a medical device company designing clinical electrocardiographs for three years. Fed up with the unreasonably high price, cumbersome design, and dishonest distribution practices of clinical ECG machines, I started working on a high-quality ECG that is different. After a couple of failed attempts to get funding for the expensive certification process and completely running out of funds, I decided to publish everything under a license that allows others to finalize and manufacture it or reuse parts of it in other projects." From the project page linked: "The software is licensed under WTFPL, the hardware under CERN OHL 1.2," and a few words of disclaimer: "Note: the design is functional but unfinished, it needs additional work before it can be certified. There are also some known bugs in it. Most of the software is unimplemented." Conventional crowdfunding may have fallen short, but Isza has proposed an interesting bargain for working on the project again himself: that will happen if he raises via donation half the amount of his original $22,000 investment.

34 of 134 comments (clear)

  1. Why isn't all medical equipment open source? by The123king · · Score: 5, Insightful

    Seriously, why? The study of medicine has only one goal. Improve the life expectancy of human beings. Surely any profession in which proactively benefits the human race should be patent and royalty-free to allow other human beings to improve and advance the technology. Why should we pay $1000's for clunky and out-dated machinery when computerisation has allowed us to minaturise, improve and cheapen, the manufacturing of medical devices.

    I'm glad there's some people in this world who see sense rather than paychecks.

    --
    If you gave me a choice between a printer and a giraffe with explosive diarrhoea, i'll get my ladder and my raincoat
    1. Re:Why isn't all medical equipment open source? by Okian+Warrior · · Score: 4, Insightful

      The study of medicine has only one goal. Improve the life expectancy of human beings.

      I believe the flaw in your argument is in this statement.

    2. Re:Why isn't all medical equipment open source? by laird · · Score: 4, Insightful

      In the US "maximize the revenue of medical providers and vendors" is how we roll.

      That's why in the US there's almost no money spent educating people on basic health and nutrition, minimal regulation to protect our food supplies, and $billions spent marketing fast food that's causing massive health problems and early deaths for millions of Americans. But businesses in the healthcare business are making record profits. Yay!

      --
      Enable 3D printed prosthetics!
    3. Re:Why isn't all medical equipment open source? by Okian+Warrior · · Score: 5, Insightful

      A cynic would point out that the cost to develop these devices is very high, and companies must recoup their losses.

      A mathematician would point out that, from a game-theory point of view, having one group of people come up with safety requirements without any burden of cost for the implementation of those requirements leads to stifling over-regulation.

      Specifically, this leads to "safety at any cost", when in reality the cost of safety should be compared to other costs.

    4. Re:Why isn't all medical equipment open source? by Anonymous Coward · · Score: 4, Interesting

      Actually profits are down. LOTS of medical practices have sold out or gone bankrupt over the past 5 years.

      Computers have not made your medical care cheaper. FDA approval for medical devices are not a walk in the park. Vendors take on a HUGE risk selling these devices and don't want to go to jail over a $10.00 device and neither does your doctor. EMR software for medical practices can be a pain and they are expensive. I suggest that anyone interested should, read Hacking Healthcare. It is a lot more complex than you would think.

      Yes, fast food and bad eating habits are going to kill us all. I fight the habit off daily. But if you try to regulate or educate people on it you are labeled a socialist or something else. City of New York and now some place in Cali? Can't say I care if someone is eating badly or not until I think about the health care system we are going to now. Then I think about how I am actually paying for their bad choice as well as mine.

      Now it is great that someone is working on an open source solution to lower the cost. But if it doesn't get certification, It will probably not get used. At least not in the U.S. no one wants to fight that battle in court when a mistake is made.

      This has only reminded me of a recent court case.
      http://www.huffingtonpost.com/2012/06/01/william-martinez-threesome-death-family-medical-malpractice-sreenivasulu-gangasani_n_1563247.html

    5. Re:Why isn't all medical equipment open source? by K.+S.+Kyosuke · · Score: 2

      That doesn't even matter. What is the safety of not visiting a physician because of financial constraints? At one point, the diminishings returns on "safety at any cost" will mean that the outcome for the society at large will start declining.

      --
      Ezekiel 23:20
    6. Re:Why isn't all medical equipment open source? by girlintraining · · Score: 5, Insightful

      In the US "maximize the revenue of medical providers and vendors" is how we roll.

      Excuse me, but you're wrong. Very. Wrong. You think your doctors, nurses, etc., have an easy time of it? Let me break it down for you:

      Wanna be a doctor? You're going to need four years of medical school. Cha-ching: $156,000 was the average student loan debt for a graduate. In 2009. You may have heard; tuition has been showing double-digit percentage gains every year since. But let's ignore that. Now you'll need another five years of surgical residency training. Yay! You get to start making money here! Er, $56,000 a year average. Great, right? Nope. That average salary comes with the expectation of up to eighty hours a week. Rumor has it the government plans on putting restrictions on this; if that happens, your 5 years just became about 7. Fun fact: Most residents defer their student loans during this time period (did you say compound interest? Oh yeah baby!). There's another cost too: Medical malpractice insurance. It's quite a bit higher for residents, but let's say you make it all the way out into the field. Yay! You're a doctor! A prestigious position where you make so much money even Tony Stark would nod his head approvingly. Well... actually, no. For all this work; you can now earn $156,000 a year as a pediatrician or family practitioner. Nice, huh? Not so fast there, sunshine: The government wants its due: Your takehome is now about $4022 biweekly, or a take home of $104,572 per year. Om nom nom! And don't even think about trying to get a specialist job for another 4-8 years.

      Oh, and now that you can pay those student loans you might have forgotten about? on a 10 year repayment plan, your monthly loan payment will be $1,795.25 or thereabouts. That's $21,543 per year. Sooo now your take home is down to $83,029. But wait, there's more: Medical malpractice insurance to the tune of around $3,000 per year. Burp. $80k.

      So after 11 years of hard work, maybe more, you can finally sit back and enjoy your first year's wages. You probably won't reach parity with your non-college educated peers that are making median income for another 7 years, but hey -- it's a prestigious line of work. Oh, I should mention one more thing: Thanks to the medicare crisis, your salary's probably going to drop by 15-20% over the next 7 years because of all those old people that are going to no longer be contributing anything to the economy except racking up medical bills and passing on their massive consumer debt (which eclipses the national debt, by the way -- you think the government is bad at managing their checkbook, wait until you see what the Boomers did with theirs) to those still able to work. And you can bet the top earners -- of which you are now in that category despite your own high debt load, are going to be paying for.

      And to use your own words, "That's why in the US there's almost no money spent educating people on basic health and nutrition" ... except that's a lie. We do educate them, they just don't listen. Not that it would matter much at this point even if we shovelled piles of cash by the dump truck load into our public schools... because the Boomers bled us dry, and there's nobody investing in infrastructure or anything anymore. They lived beyond their means, and I sincerely doubt America will recover, at least not in our lifetimes. Get used to each generation earning less than the previous for the next 70 years or so.

      --
      #fuckbeta #iamslashdot #dicemustdie
    7. Re:Why isn't all medical equipment open source? by girlintraining · · Score: 4, Informative

      The study of medicine has only one goal. Improve the life expectancy of human beings.

      I believe the flaw in your argument is in this statement.

      You're both wrong. That's not why our health care system went to hell. It's insurance companies. They're turning a profit on human misery. But ignoring that side of the equation, there's also excessive regulation. This article talks about how low-cost it is to actually make the equipment. And they're right. Meeting the standards is pretty easy. But that's not where the costs are. As I'm sure the designers know, or will soon discover, it's getting certification for their equipment. Certification is the reason why a table-side bed in a hospital costs $500, but you can pick up the exact same item, for home use, off Amazon for about $35 plus S&H.

      If you want to fix the health care system, you're going to have to do something you don't want to do: You're going to have to give up on capitalism. Private-run insurance, private-run health care, private-run... kill it. Burn it all to the ground. Europeans figured out a long time ago that capitalism is good with non-essential commodities, but it's absolute shit with natural resources or essential goods and services that have a non-trivial cost. Electricity. Telecommunications. Gas. Internet. Health care. Transportation. These are not things that capitalism has done well with; The owners of these key resources make a fuckton of money, but the rest of us are enslaved to poverty to do so. Capitalism only works when there's a natural tendancy towards competition, and there isn't any in those areas. The invisible hand can kiss my invisible ass, because it doesn't work the way people have been led to believe. It works well much of the time. It works very well when the cost of entry into the market is low and there's no natural monopoly (like land, to use the quintessential example). But to say it always works, or to try and shoehorn it into markets and situations that it has a poor history with, is stupid. Nothing always works. Ever. Capitalism is no different -- put it to good use where it is efficient and effective, but it's not a "spray on all surfaces" sort of ideology. In fact, no such ideology has ever been created.

      --
      #fuckbeta #iamslashdot #dicemustdie
    8. Re:Why isn't all medical equipment open source? by girlintraining · · Score: 4, Interesting

      P.S. I can already hear the heads bubbling over of certain people because I mentioned regulation as being a problem, yet am suggesting institutionalizing health care. This is not the paradox you think it is: Much of our regulation is due to private interests demanding it. Just ask Tesla Motor Co. Canada, Spain, the UK, they've all done quite well at providing decent health care in an institutional capacity... though the UK system is showing signs of needing some attention due to neglect of late.

      And yes, I know you can probably demonstrate any one of fifty different angles and case studies on how those systems are sub-optimal compared to ours. I answer with two statistics: Infant mortality in the United States, and current life expectancy. In those countries, they're going down, and up, respectively. In ours, the reverse is currently true. It's generally true that if you have money here and get sick, this is the best place to be. But in those countries, you don't get sick as often, because there's a focus on preventative care, not treatment. Here, specialists outnumber general practitioners about 3 to 1. There, the reverse is true.

      If we look at it from a macro-perspective; At the societal level, their system is beating ours on both costs, and quality of life. And if the overall health of the general public, while maintaining reasonable costs, are your priorities, you cannot support our current privatized system.

      --
      #fuckbeta #iamslashdot #dicemustdie
    9. Re:Why isn't all medical equipment open source? by K.+S.+Kyosuke · · Score: 2

      But a society may decide that even if mathematically they got the odds of a medical device causing harm to be perfectly equal to the odds of doing nothing, that morally one may be preferable to the other.

      I think that "many people are short-sighted morons" would be a shorter, yet semantically identical expression of what you've just elaborated.

      --
      Ezekiel 23:20
    10. Re:Why isn't all medical equipment open source? by sjames · · Score: 4, Insightful

      Profits are down for medial practices. They've skyrocketed for device manufacturers and the pharmaceutical industry. It's a mixed bag for hospitals.

      Computers and electronics have brought costs down everywhere they've been applied except medicine. There they have boosted profits but haven't benefited the consumer.

      There is no reason equipment used in non-emergency practice needs to be built (and paid for) like lives hang in the balance. You could afford to throw away a LOT of failed ECGs that cost hundreds before reaching the price of a single current model. It's not as if a malfunction will cause it to display a normal ECG when the patient isn't normal.

      Regulations and lawsuits are a popular excuse for gouging but it just doesn't hold water.

      As for the link you provided, if the equipment had been less expensive, the man might have gotten his test sooner and tragedy avoided. Otherwise the problem had nothing to do with the quality of equipment at all. It's down to medical judgement and dumb luck.

    11. Re:Why isn't all medical equipment open source? by gweihir · · Score: 3, Interesting

      You misunderstand the system. These high costs of becoming a doctor serve as indoctrination, making it very clear to any prospective doctor that this is not primarily about helping people, but primarily about making money. Sure, a few idealists that manage to keep their personal ethics intact remain, but the majority of prospective doctors gets the message loud and clear.

      I do completely agree about your last statement though. The US population has become so anti-knowledge that even solid, well-researched and dependable information sitting in plain sight gets ignored by most. As to the money question in education, it is not a cost issue. Other countries manage to give children far better educations at significantly lower cost. That is why "shoveling piles of cash by the dump truck load into our public schools" would have no effect whatsoever. It is not a problem of funding. The problem is that the US does not understand what a good education is at this time. Not that it ever did, from what I can tell, indoctrination was always paramount over independent thinking, at least below the PhD level. And PhD students are (or were until recently) mostly imported, at least in the STEM area. The reason is that US educated students just do not cut it, except for a small minority. As far as I can tell, it is not a question of "recovering" either, more a question of starting to import all that foreign talent again. But with the reputation the US has these days, and with it becoming worse daily, I do not see that getting fixed for a long, long time, if ever. Your 70 years might be entirely realistic, but possibly with an economic crash in there as well.

      --
      Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
    12. Re:Why isn't all medical equipment open source? by sjames · · Score: 2

      Currently, doctors are being squeezed, but the equipment manufacturers, hospitals, pharmaceutical companies, and universities standing behind the doctors are making a killing (sometimes literally).

      However, $80k/year after taxes ain't bad. It's a lot more than most of the doctors patients will ever make.

    13. Re:Why isn't all medical equipment open source? by Anonymous Coward · · Score: 2, Informative

      Wanna be a doctor? You're going to need four years of medical school. Cha-ching: $156,000 was the average student loan debt for a graduate.

      Wrong it's 8 years for a doctor, it's 4 years just to become an LVN (Licensed Vocational Nurse) while to become an RN/NP (Registered - Nurse Practicioner) or a PA (Physicians Assistant) Takes 6 years. As The main difference between the RN/NP/PA is the 2 years residency requirement for that Coveted MD (Doctor) title. The $150,000 is for a Nurse/PA. A Doctor has over a quarter million dollars in debt by the time they graduate (don't forget Malpractice Insurance is part of that debt).

      Tack on another 4 years for specialty school (Orthepedic/Neurology) and you're now talking a full Million Dollars in debt along with 12 years of schooling before you even begin making the money needed to repay that debt. Now there are several programs that can and do make it feasible for folks to become doctors but they're either the Militay or offer to discharge a full year of debt for every year served in an under-served region (rural) and let me tell you, docs in those programs don't make nearly as much as private practice in New York, San Francisco, D.C.. and other large metro areas.

      And as one of those folks who has to have that education, where is it? I've never seen one lick of it and I've been insulin dependent for the last 5 years. Education? Depends on where in hell you're at. I live in a rural area and the medical offerings are slim to fucking hours in the ER if you're sick. We've got 100k people in the region but spread out over an area of 200 square miles (50x4) Yea, we have lots of doctors here. Like hell, it's a god damn 60+ mile drive from where I live to the nearest metro region that has plenty of docs and that's only got a population of half a million (5x what we have).

      If we do have docs, then it takes a week to get an appointment that means wasting at least 3 hours on due to the backlog and it isn't getting any better.

      Posting AC to preserve Mods
      Fast Turtle

    14. Re:Why isn't all medical equipment open source? by lakeland · · Score: 2

      It's hardly fair to compare a doctor's take home pay to the median income in the US. People going to med school are both smart and hard working, try comparing the income of smart, hard-working non-doctors to doctors and I think you'll find the difference is far smaller.

      Yeah, $80k after applicable deductions is a good income. Approximately 12% of Americans make that much or more.

      I tried to find some data on the median income of people with similar work ethic and IQ to doctors but couldn't find anything sorry.

    15. Re:Why isn't all medical equipment open source? by gweihir · · Score: 2

      Ah, those with a simple model of the world... And those that think screaming and swearing makes them right...

      Bit of a simplistic approach to discussion you have there. Not all bow to open aggressiveness and it certainly does not make you right. In fact it gives a high incidence score to the assumption of you being wrong, because otherwise you would not have to resort to an approach this primitive and transparent.

      And a bit of reading comprehension would help as well. I never claimed the people going into medicine _want_ this. It is just what happens to them in the US. Hint: In other countries people do not come out of medical education deep in debt. The doctors in many of them are not worse then US doctors. This begs the question what the US is doing differently. I just pointed out the obvious.

      --
      Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
    16. Re:Why isn't all medical equipment open source? by fatphil · · Score: 3, Informative

      No. In every European country where I've lived (3 of them) essential public healthcare is free. Non-essential healthcare (e.g. having a wart removed, 4 15 minute slots, say) costs almost nothing, and everyone is treated equally. Different countries cost different levels, but they're roughly on a par PPP-wise. There is also the option of private health care, and you'll be treated by the same doctors, just queue less.

      --
      Also FatPhil on SoylentNews, id 863
    17. Re:Why isn't all medical equipment open source? by gweihir · · Score: 2

      Well, whatever the subject, you have just demonstrated that you are incapable of rational discourse. And blind to things that are glaringly obvious. Pathetic.

      --
      Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
    18. Re:Why isn't all medical equipment open source? by Anonymous Coward · · Score: 2, Insightful

      Medicine amounts to a custom job performed by a highly trained specialist. Prices will vary based on geography, supplier contracts, predominant payer (e.g. specific insurer or medicare). and how the individual doctor practices (e.g. some prefer expensive new drugs/devices, others are more conservative, and still others are downright paranoid with tests). A simple coke will vary in price by an order of magnitude between stores, so why is it surprising that one hospital charges $1,000 for an MRI while another charges $3,000? Something like a cholecystectomy will vary a heck of a lot more, given how complicated the case was and what equipment the surgeon prefers to use.

  2. Really internet? by Anonymous Coward · · Score: 4, Insightful

    We can come up with a million dollars to make a sequel to one of the worst games of all time, Myst, and we can't come up with $22,000 to actually change the world?

  3. Re:umm, ok...? by Okian+Warrior · · Score: 2, Insightful

    Here's a medical device that meets none of the standards of today, and it has bugs that need to be worked out.

    There's a difference between "meets none of the standards" and "compliant, but untested".

    Please don't sell something short by making unwarranted accusations.

  4. Some wrong assumptions made in comments thus far.. by Da_Biz · · Score: 3, Insightful

    I have been a certified/licensed EMT for over 10 years.

    "Medical devices are expensive to make."
    For many commonly-used devices (ECG, pulse oximeter, etc.), the level of technology implemented is magnitudes less than that of a decent smartphone. Sure, these aren't mass market items--but I'm also hard pressed to understand why it doesn't make sense to have an alternative to a LifePak which easily costs $15K+. Case in point: the AED you can easily buy from Costco in the neighborhood of $1K--and has lots of sophisticated logic. Just because the thing has blinky lights and makes "bing" noises doesn't mean it should be exorbitantly priced.

    "People need a manufacturer big enough to sue."
    Circular reasoning on the best of days. Does a commercial implementer of this device need a legal team? Yes. Is the pragmatic implementation of a device at lower cost that's reliable and lawsuit-resistant possible? Absolutely.

  5. Re:umm, ok...? by Maury+Markowitz · · Score: 2

    > There's a difference between "meets none of the standards" and "compliant, but untested".

    No there isn't. You comply with the standard when the pass the tests. You comply with nothing before that point.

    The long and short of it is that you don't get sued for false positives, but you DO get sued for false negatives.

    Any device that can't pass testing and demonstrate that the balance is in the favour of false positives simply will not be used.

    Period.

  6. Re:umm, ok...? by gmuslera · · Score: 2

    In the other hand, a device that you can't buy or is not available probably will harm you more than not having it. Making devices/drugs/whatever that could be the difference between life and death for a lot of people, but have to have to add a "sue protection" price bump makes it not available for anyone,

    Making it open source, and easy for anyone to build it also make people to decide which is the biggest risk, using it or not. Big companies could make the insured, high quality, throughly tested and expensive version, smallish/hobbyist could make the evaluate and take your risks cheap ones. They are not exclusive alternatives, and should not be neither.

  7. Re:umm, ok...? by jd · · Score: 4, Interesting

    Modern medicine works on the basis that dead people rarely sue. The same goes for other mission-critical systems like fly-by-wire avionics. To be fair (me? fair? well, it was bound to happen eventually), a lot of companies put in a lot of effort to do a good job. The problem is, if you're on life-support or flying at 20,000 feet, there is every probability that a software crash will be followed by a crash of another sort. There have been very close calls of this nature in the past.

    But what would happen in the event of a fatal incident? In virtually all industries that use mission-critical systems, there are disclaimers and waivers that prohibit lawsuits.

    Even in non-critical systems, EULAs invariably state the manufacturer/developer is not at fault, no matter what, even if they admit they are, and to use the system you have to agree to that. You aren't given a choice.

    Open Source licenses often say the same, but Open Source allows you to validate the system to your satisfaction. You are prohibited from any code analysis and certain forms of runtime analysis with closed systems. Thus, although neither provide any form of warranty or fitness for use guarantees, you are capable of at least certifying open source as fit for use. No commercial product using computers will provide anything remotely close.

    --
    It's a small world and it smells funny; I'd buy another if it wasn't for the money; Take back what I paid (SoM)
  8. A good start by jd · · Score: 4, Insightful

    But only a start. Researchers using - it was either 48 or 64 leads - were able to identify specific muscles that were showing abnormalities long before those abnormalities turned into organ failure. Isolating problems to that degree just by collecting more of the same data would seem a great way to help prevent problems serious enough to show up on a conventional system ever developing in the first place.

    In other words, why not turn thus from being open source medicine into an open source debugger? Why let things get to the point where medicine, rather than our own creativity is needed?

    --
    It's a small world and it smells funny; I'd buy another if it wasn't for the money; Take back what I paid (SoM)
  9. Re:12-lead? by Anonymous Coward · · Score: 4, Informative

    Okay, this may be a stupid question, but I only count 10 leads in the pictures of the device, so where/what are the other two? Grounds?

    lead != wire in this context, it refers to the electrical paths through the body between various parings of the 10 wires.

  10. Note: the design is functional but unfinished by Gothmolly · · Score: 2

    The curse of Open Source. Good luck getting that last 10% finished.

    --
    I want to delete my account but Slashdot doesn't allow it.
  11. Re:Really internet?... marketing by anon+mouse-cow-aard · · Score: 2

    fwiw... It's 230 K, not 22 K$. but doesn't change your point. ECG is so nerdy... He should emphasize other uses, and try to market based on that. He could call it a "biorhythmic training device for understanding the crystals, and getting in touch with your aura. or talk up the "biofeedback" aspects of it, how it will help with meditation. That will sell to one crowd. Figure out how to use it as a kind of game controller, and the internet will fund in a (wait for it!) heartbeat.

  12. Cost and profit in the medical industry ... by Anonymous Coward · · Score: 2, Funny

    Low cost, high profit: Perhaps commercial ECGs and other medical devices are built just like this power supply:
    http://thedailywtf.com/Articles/Power-Supply.aspx

  13. every gym should have one by jclaer · · Score: 2

    I lost a son, age 25, to sudden cardiac arrest. He left the gym, died a half hour later in his office. We thought he was the healthiest one in the family. Every gym should have an EKG machine as well as an AED. I hope you never learn what I know --- no loss exceeds losing a child. Search for Jos Claerbout

  14. "dishonest distribution practices"? by terryk29 · · Score: 2

    "...of clinical ECG machines" (summary). Does the submitter or anyone else care to elaborate?

  15. Re:WTFPL by gl4ss · · Score: 2

    wtf is wrong with you guys? it has no official medical use before certification and he can't afford it. it has no implied warranty. there's no fucking way to sue 'em if you use it for something, if you want to use it for something go through certification first.

    and as far as copyrights go yeah, it DOES have meaning: do what the fuck you want. besides, FSF agrees. it's as free as you can get. what the fuck is wrong with people who think it has no meaning in copyright? because it sure fucking does! why the fuck it wouldn't? because it has "fuck" in there in the name? it gives you explicit permission to do whatever the fuck you want with it.

    you don't like it? well fuck, create your own fork and license it under gpl! or bsd! or apache!

    (and I can think of a bunch of things more necessary to have warranty disclaimers like any heating system control systems like on every friggin 3d printer which may burn your house down)

    http://www.wtfpl.net/about/

    --
    world was created 5 seconds before this post as it is.
  16. Re:umm, ok...? by harlequinn · · Score: 2

    "Any device that can't pass testing and demonstrate that the balance is in the favour of false positives simply will not be used. Period."

    Except if you're in a third world country where they don't have standards and where even something that is only right even only half of the time is infinitely better than nothing.

    "> There's a difference between "meets none of the standards" and "compliant, but untested".

    No there isn't. You comply with the standard when the pass the tests. You comply with nothing before that point."

    Yes, there is actually. You can run the test yourself and meet all the standards yet not get certified because you are not an official testing body. E.g. I can get NASA to test that the bicycle helmet I made meets the Australian Standards, and you can bet your arse that it'll be an accurate result, yet it still won't be certified since they aren't certified to test it.