Category: Hot Topics in Standardization

News and Views from the World of Standards

Are Consortium Standards Free?

Are Consortium Standards Free?  I’m looking at the broader issue of standards and public access for my presentation at the SES (the Society for Standards Professionals) Convention in Denver this month.  There are some standards that are made available for no charge.  I reviewed the Mil Specs and Standards set last week.  Today I’m going to take a look at Consortium Standards.

What is a Consortium?  Luckily, one of my co-panelists has a webpage with a detailed answer to this question: Consortium Info Essential Guide.  For our purposes today, let’s just say that a consortium is a group that has joined together to promote a specific technology or technological solution.  They often fast-track the development of standards in a particular area to provide the technical support to get a product or service to market quickly.

Why is a Consortium different that other Standards Developing Organizations (SDOs)?  The consortium process is often called “pay to play.”  That is, the standards system used is not particularly open in the classical standards sense.  It is a system based on the participation of a few key players.  These folks support the activities of the consortium with dues, often rather expensive in comparison with other SDOs.  They are interested in rapid consensus and deployment.  Their mission is to get their standard(s) in use as quickly as possible.

Are consortium standards provided at no charge?  Usually during the development process, consortium standards are not available.  This is primarily in the interests of time (and sometimes business interests as well).  Introducing additional players into the mix can end up in too much input, slowing down the process.  It may also give competing technology advocates a chance to see what is going on in a certain group.  Or give them a chance to derail the consortium’s goals.

However, once consortium standards are adopted and published by the group, they often are available at no charge.  This is to support the mission of the consortia — Wide adoption of the technology as a tool for promotion of the group’s products or solutions.  Let’s think of the original business strategy for the PC industry — Make PC standards open in comparison with Apple closed standards as a tool for increasing marketshare.

So consortium standards are not free — they do take money to develop, as do most of the standards we use.  However, by choosing to make the final publications available at no charge, a consortium is furthering its core mission — adoption of a specific technology.

What happens if a consortium standard is widely adopted?  How is the standard maintained?  This is an issue of standards development that presents a problem for many consortia.  The authoring group is brought together to get a technology adopted.  When it is, the group’s mission has been met.  Usually, at this point the consortium is dissolved.  But about the standard?

Much to the initial suprise of the traditional SDO community, it is at this point that many consortia hand over their publications to another standards organization.  IEEE has been the happy receipient of a number of standards developed by various consortia.  Why?  A traditional SDO is not only geared up to develop standards but also support them throughout their lifecycle.  For example, standards should be able to be revised if technical errors are discovered.  Standards should be reviewed once every 5 years.  Standards need to be distributed to a potentially large audience over a long span of time.  And even when cancelled, they still may be required for legal or regulatory purposes.

And when this transition takes place, does a consortium’s standard still get distributed at no charge?  Usually not.  While the costs for development are borne by the consortium’s organizers, the costs for maintenance are not.  So a traditional SDO who inherits this type of standard usually begins charging for it immediately.

The use of no-charge distribution of standards is a tactical choice for any consortia.  It is a tool to be used to achieve an end.  It can be very effective but does come with a price.  Many of the benefits of traditional standards development (open process, public review, and so on) are not available during the consortia process.  However, in exchange, a consortium will be able to gain consensus quickly, bring a standard to market in a timely fashion, and attempt to gain penetration of the market by open access to the document(s).

For a tranditional SDO, use of no charge distribution should also be considered a tactial choice.  It should be considered when issues of public interest and achievement of organizational goals make a strong business case and the costs of standardization can be covered by means other than standards sales.

Are MIL Specs and Standards Free?

Are MIL Specs and Standards free?  Should all standards be free?  How should we pay for the development and maintenance of standards?  These are some of the questions that I’ll be talking about at the SES (Society for Standards Professionals) convention in August.  As the standards community reflects on the impact of technology, questions about copyright are front and center.  It’s a basic Internet question:  Should information be free?

Let’s take a look at the DoD system of standards.   They are correctly referred to as public domain documents.  This means that they are not covered by the laws of copyright.  You can use them at no  charge but they are paid for by U.S. taxpayer dollars.  So to answer our question “Are MIL Specs and Standards Free?” we must say no, they are not free.  However, the costs are not borne by the user but by the public at large.

How has this  worked out?  Is this a model that industry should use?  Why was this system developed and what has it accomplished?

DoD specs and standards were developed to support the purchasing needs of the U.S. military.  Since government purchasing can have an impact on jurisdiction communities, it has to meet both practical and political needs.  It has spawned great successes and some well-documented failures.

Back in the day, I saw some shortcuts to good practices in the areas of authoring.  For example, one of our customers was requested to write a mil spec for an electrical component.  He added requirements that made his company the sole supplier for the item.  How could this happen?  The military standardization program just didn’t have enough resources to write all that documentation necessary in-house.  So on occasion it enlisted the help of the vendors themselves, with mixed results.

Other authoring and distribution challenges exist.  Finding appropriate tools for authoring and for conversion of legacy documents has been expensive.  The problems of providing paper copies have thankfully been resolved with the use of pdf delivery.  However, helping mil spec customers keep up with changes continues to be problematic.

Another issue created by this use of an exclusive set of documentation is certification.  In the past, visits to thousands of suppliers were needed to make sure products met the requirements.  Now with the adoption of the ISO 9001 requirements, third party certification has a place in the procurement system.

The development of a standards program specifically for government procurement did lead to purchasing scandals in the past.  Dr. Perry’s Mil spec reform in the 1990’s was an effort to reduce the DoD standards collection to a set comprised of military-only requirements.  For all widely available products, the military and other federal level purchasers moved to the use of industry standards.  So, much of the burden of cost of standardization is no longer paid for by taxpayers.  And now military purchasers have the ability to purchase goods in the open marketplace which saves even more millions of dollars.

The old DoD standardization program did have one shining benefit:  The standards set was widely used thoughout industry.  This penetration of the marketplace was an unintended side effect of the no charge availability of the documents to users.  When the DoD decided to cancel many of their publications during MIL Spec reform, it was a real blow to many standards users.  While most companies moved to industry specs, there is a significant number that stopped using standards altogether.

Of course, when it comes to standards, some developers are interested in fast adoption of a new technology.  In these cases, no charge distribution is a real plus.  But for many traditional standards developers, their documentation supports less “sexy” applications.  In these cases the funding for the transparent development and maintenance of their standards may be best achieved by selling the documents themselves.

The standardization community like other content creators will have to deal with many questions regarding copyright and the distribution of information moving forward.  Many of our common public issues like the promotion of trade, the health and safety of our population, environmental stewardship, and interconnectivity of products can be solved with the use of standards.  Finding a way to promote the use of proven solutions provided by standardization is one factor.  Finding a way to support the uncompromised development of this data is another.

New In Vitro Diagnostic Devices Regulation (IVDR)

There’s a new In Vitro Diagnostic Devices Regulation (IVDR) on the way, likely to be complete at the end of the year or the beginning of next.  Then of course, there will be a time lag as the text of the revised European Union (EU) regulation is prepared for distribution.  For those of you in the MedDev business, this and the new Medical Devices Regulation (MDR) will definitely have an impact.  Let’s take a look at some of the probable areas where you can expect change.

For the medical device industry, standards and regulations go hand in hand.  This is especially true in the EU since a number of regulatory requirements can be met with the use of compliance to specific standards.  So this major revision of these EU regs will require some changes to the way you do business.

First, you’ll want to know that it’s expected that the definition of IVD MD will be expanded to include any device that is a reagent, a reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended to be used in vitro.  This is for diagnosis (predisposition to a disease, possible reactions to a treatment, any collection of blood and/or other tissue samples).  You’ll only be exempt if your products are for laboratory or research use, plus 3 other special cases.

The proposed new IVD Reg includes a new supply chain regime and expands the Eudamed database (to be renamed the MDR Eudamed).  FYI:  The MDR Eudamed identifier number is intended to aligned with the FDA UDI numbering scheme.  It’s expected that there will be perhaps 25,000 European manufacturers in the database, as well as a similar number located outside the EU.  Not only will new records be added, but old records will be retained.

Other regulatory changes for IVD include a ‘lifestyle tests’ extension when working with the concepts of purposes and prediction.  Also, IVDs will be evaluated by the risk classes developed by GHTF (Global Harmonization Task Force) instead of the current list-based system.  Only Class A (low risk) will be exempt from conformity assessment by a notified body (NB).  This change in the risk assessment means changes in conformity assessment as well.  Many IVDs that can be self certified will now need to be certified by an NB.  Estimations put the change from 20% of IVDs now to 80% needing 3rd party certification when the regs come into effect.

Lastly, clinical performance studies will be required to support the CE mark under the updated IVDR as it is currently being proposed.  What does this mean for you?  Likely you’ll need to product significantly more clinical evidence.  You’ll need to be able to prove scientific validity, as regulations move to making you fully responsible for the clinical utility of your IVDs.

When will compliance with the revised In Vitro Diagnotistic Devices Regulation be mandatory?  Unlike the new MDR with it’s probable 3 year transition period, there may be a 5 year “grace” period for you to make the migration from the old regulations to the new.  And of course, should the new MDR Eudamed prove a failure, the regulations to implement it will not be enforceable.

If you’d like additional help in monitoring the new directives and obtaining the supporting standards as they are released, please get in touch with us.  Here at Document Center Inc. we support many medical device manufacturers.  We have a range of services as well as standard sales all geared to improve your compliance for the various certification schemes your product must comply with.  Use our webstore, www.document-center.com, for your purchases.  Or contact our staff by phone (650-591-7600) or email (info@document-center.com) for additional assistance.  Make us your Standards Experts!

Brexit and BS EN Standards

Now that we’re all getting used to the idea that the U.K. has voted to leave the European Union, what about the Brexit and BS EN Standards?  Does the Brexit affect Britian’s participation in CEN and CENELEC and the publishing of the BS EN documents?  Will BSI continue to act as a notified body?  Will it continue to be able to certify your organization’s products for sale within the EU?  Does this rejection of the regulatory burdens placed upon the U.K. by the EU affect British standards making?

For those of you who have referenced BS EN standards in your product documentation, you can breathe a sigh of relief.  While there will be some changes, the U.K. will remain within the CEN and CENELEC standards making process.  BSI should continue to adopt and distribute the BS EN standards.  And should their status as a notified body be withdrawn, they will surely find a notified body that they can represent in order to continue their certification activities.

How can this be?  Doesn’t the Brexit mean that the U.K. will not be a part of the European Union any longer?  Actually, there are several non-EU countries already participating in both CEN and CENELEC.  These include Iceland, Norway and Switzerland as well as candidate countries Macedonia and Turkey.  This is done by way of particiation in the European Free Trade Association (EFTA).  There is no suggestion as yet that the U.K. would pull out of this group.

There will be one notable result of leaving the EU for Britian:  It won’t be involved in the formal discussions in CEN and/or CENELEC on the needs of the EU with regards to any specific standard.  It will also be out of any discussions about mandates or decisions about harmonized standards.

So while Britians may be thinking that the Brexit vote will reduce the regulatory burden, this will be true only to a limited extent where goods and trade is concerned.  Part of the requirements that accompany national participation in CEN and CENELEC mandates adoption by a specific date.  They also dictate that duplicating or conflicting national standards be withdrawn by a specific date.  So while certain domestic regulation will again revert to the nation, much of the overhead of compliance with EU Directives and the Harmonized Standards system will remain.

Should you be concerned or want to use EN standards from an alternative European source, please get in touch with us.  Here at Document Center Inc. we have a number of options for you with regards to your EN standards.  Take a look by searching for standards at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

Elsmar Cove is back!

Just a quick note for all of you formerly heart-broken Elsmar Cove fans — It’s back!  It’s been purchased and re-launched by Peachfarm Internet Properties, but it has all the look and feel and what looks like much of the information of the old site.  You’ll find it at http://elsmar.com/Forums/index.php.

I haven’t got much more information for you at the present moment.  Of course, there’s been a lot of litigation surrounding Elsmar Cove, so it’s not surprising that the site re-opened without a lot of fanfare.  I understand that much of the details will be made public at some later date.  When that information is released, I’ll review it to bring you all up-to-date.

Meantime, there’s a lot of people who are delighted to see the site re-opened.  If you’re one of them, be sure to go to and use Elsmar Cove as much as possible to give a vote of support to the newly relaunched service!

Claudia

SMPTE on the Red Carpet — Awarded an Emmy!

SMPTE, the Society of Motion Picture and Television Engineers, has been awarded an Emmy!  We don’t usually think of standards as a glamour industry, but here it is:  A picture of SMPTE staff member Peter Symes on the podium getting accolades for SMPTE’s work on closed-captioning for Internet content taken from movies and television.  And who was there on the podium as well?  Representatives from Netflix, HBO, Telestream, and W3C.  Nice crowd you run with, SMPTE!

Of course, organizations like SMPTE provide the hidden infrastructure that makes many of our new products and services work.  This work is laborious, taking resources of both manhours and dollars and cents.  So in many ways, SMPTE is also representing those many technical folks who take the time to participate in the standards process.  And the SMPTE Emmy also reminds us that good standardization does rely on industry to provide much of this investment.

What is the SMPTE Emmy for?  It was awarded for the development and publication of the SMPTE Timed Text® (SMPTE-TT) profile.  This is work that was built upon the Timed Text Markup Language (TTML) provided by W3C (the World Wide Web Consortium.  It allows for closed captioning that was done for television broadcasting to be repurposed for Internet distribution.

Another great thing about the development of this standard is that it highlights the participation not only of industry but of the public, especially those with a vested interest in the development of this standard.  SMPTE established a liaison with the Coalition of Organizations for Accessible Technology to make sure that it was appropriate for the requirements of the disability community.

For those of us in the Standards Community, public recognition beyond that offered by the various Standards Organizations themselves is not a common sight.  So congratulations again to SMPTE and thanks to the National Academy of Television Arts & Sciences for the recognition.

You can read more about this prestigious award on the SMPTE website — Here’s a link to the Press Release for the SMPTE Emmy.  It also contains information on SMPTE member Chuck Pagano who was awarded a NATAS Lifetime Achievement Award.  And the press release also mentions a number of SMPTE company members who were honored during the ceremonies.  Really a pleasure to see the public acknowledgement of the contribution of SMPTE and it’s members.

What are FDA Guidance Documents?

What are FDA Guidance Documents?  Why should we use them?  Do they have any legal weight?  These are questions that many organizations have when trying to understand FDA compliance and how the FDA works.  Since FDA Guidance Documents contain a wealth of information that many of our Document Center customers find to be very helpful, I’m going to discuss these publications in general today.  My goal?  To give you a better idea of when and how to use them to improve the way you interact with the FDA.

Guidance Documents are published by the FDA on a regular basis.  They are a methodology they use to communicate information about FDA processes and regulatory requirements.  These publications do not have any legally binding status.  They just are a way for the FDA to let you know what their current thinking is on a topic or how they deal with certain issues or about new processes that you’ll be asked to meet.

One area that FDA guidance documents cover is submissions: how to make your submissions, how your submissions will be reviewed, what they should contain, and so on.  If you’re unfamiliar with what documentation you  need to provide and how it will be processed, guidance documents can explain this to you in general terms.  And occassionally you’ll even get an overview of a specific issue for submissions, as when the “Refuse to Accept Policy for 510(k)s – Guidance for Industry and Food and Drug Administration Staff” was recently released.  This document covers a specific situation for submissions, what it means and how to deal with it.

Another area that’s addressed is compliance, inspection and enforcement.  For anyone with FDA regulatory requirements, understanding how an inspection can take place and what the inspector(s) will be looking for is critical.  Promoting compliance with regulatory requirements over time is an important aspect of the FDA’s mission.  So you’ll find such publications as “Unique Device Identification System: Small Entity Compliance Guide – Guidance for Industry and Food and Drug Administration Staff” available to help you in this regards.

And the other main area that’s covered by guidance documents are about the regulated products or processes themselves.  You’ll find information in these publications on design, production, labeling, promotion, manufacturing, and testing.  They’re a critical communications tool for the FDA.

Some are issued for products that are “hot” as when there was some concern over sterility processes for endoscopes recently.  The FDA issued an update for it’s publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff” to help resolve this issue.  And alongside the FDA’s guidance release, standards organizations also looked to improve processes defined by standardization for this topic.

Others are issued when the FDA or industry perceive that additional information is required to get the desired level of safety and reliability necessary for the public’s well-being.  These can be about very specific topics or more general, like the recent “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings – Guidance for Industry and Food and Drug Administration Staff.”

So, as we mentioned before, FDA Guidance Documents are not a requirement, but they can offer medical device developers and manufacturers a wealth of information to improve the way that you interact with the Administration.  If you’re in this industry, you should monitor these publications on a regular basis.  One easy and effective way to do so is to review the blog.document-center.com on a regular basis.  Just yesterday, I posted the new Medical Device Guidance Documents that were released during the 4th quarter of 2016!  Check it out.

And don’t forget:  Document Center Inc. not only provides you with the standards you’ll need but also gives you access to regulations and supporting documentation necessary to achieve compliance and safety in your product line.  Order the material you need at our webstore, www.document-center.com.  Or if you have additional questions, reach us by phone (650-591-7600) and by email (info@document-center.com).  We’re here to support your quality and compliance requirements!  Make us your Standards Experts!

The New Approach – Is it working?

The New Approach was unveiled by the Europeans in the 1990’s to great fanfare and expectations.  This scheme is a methodology for industry and government to work hand in hand: Government sets expectations for product safety and the standards process fulfills them in a straight-forward way.  However, now that we’ve had a couple of decades of experience with that system, some unforseen developments are occuring.  Let’s take a look at the New Approach.  Is it working?

In the main, the concept behind the New Approach is admirable.  It provides legislators with a tool to set the bar for performance of products and services in the European Union.  And it provides a mechanism, through the use of standardization, for industry to have a clear path to meeting these legal requirements.

So what could possibly go wrong?  One of the things that I worry about is the limitations of the system made apparent with the addition of the Z Annexes.  Since I’m familiar with the Z Annexes because of the standards for the three medical device directives, I see them as an admission that the standards have fallen short of the goal.   To me these Annexes show you that standards developed to meet the Essential Requirements of particular directives may, in fact, not meet them entirely.

Now I do understand that the Z Annexes cropped up as a result of the changing concept of risk management, so perhaps this judgement is a bit harsh.  But there ought to have been a review process in there somewhere that would have flagged this issue in a different way than as it occurred.

The New Approach system was set up so that legislators would set specific expectations for performance (the Essential Requirements).  And by handing those requirements to standards developing organizations (CEN and CENELEC, and to a lesser degree, ETSI), industry and the national standards bodies would respond by providing harmonized standards.  These standards would allow industry to meet the Essential Requirements by meeting the standards.  It’s unfortunate that this system has fallen short in this particular case.

Another area for concern is the use of the national adoption system for acceptance and publication of EN standards.  A couple of thoughts here.  First, national adoptions allow for national differences.  It is a mighty task to keep track of those differences, even with the tool that NIST provides (as a support to WTO barriers to trade activities).  Secondly, it is confusing to have so many editions of any given standard.  Non-European standards users are lost at sea when it comes to deciding which one is the best choice for them.

Of course, there is one last problem.  Standards can be victim to political needs and that is certainly a concern in the European Union where the economic requirements of the individual states come into play.  I understand that when the CEN CENELEC system first was instituted, that the technical divide between the member states were resolved not only by best practices but also by political will.  I am not fully convinced that politics are out of the picture now that the first hard years of consolidation have been achieved.

Here in the U.S., EN Standards are an important part of the standardization requirements for our global companies.  We value the role these standards have come to play in allowing for the development and distribution of safe and economic products around the world.  So we have a stake in the outcomes in Europe, with the New Approach system and the use of the resulting Harmonized Standards.  We look forward to the resolution of some of the technical issues that have disrupted the system.

And in spite of some of the limitations noted above, the New Approach is working well in the main.  Many of the differences found previously within the states that make up the European Union have been eliminated by the use of the EN standards system.  So while there have been concerns over the years with this new process, we’ll have to give it high marks for improving the ability of companies to do business with and within the EU.

New AAMI CN6 – Connectors for liquids and gases

Sometimes human error can be avoided through good design.  In the case of the healthcare industry, many errors caused by connecting patients to the wrong gases or liquids can be avoided by connector design.  So AAMI has been issuing a series of connector standards recently, and the CN6 is the latest.  AAMI CN6, “Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications ,” is available now from Document Center Inc.  You’ll be able to get copies both in paper format and as pdf downloads.

First, the AAMI CN6 is a provisional standard.  It has been developed from a draft of the proposed ISO 80369-6 document.  For all of you who are concerned about whether to purchase this provisional standard now or to wait for the ISO release, you’ll be pleased to know that when the ISO document is published, you’ll get the AAMI adoption at no additional charge.

Also, the AAMI committee is chaired by the head of the FDA’s CDRH Standards Program (Center for Devices and Radiological Health), along with a medical device industry representative.  And, should the ISO 80369-6 not make it through the adoption process and ISO and not be published after all, the AAMI CN6 will be withdrawn.

Also of note is the fact that the ISO 80369 series will eventually consist of 8 Parts.  This will mean that issues of unique connectors for such applications as breathing systems, limb cuff inflations, urinary applications and so on will all be defined.

Now for the AAMI CN6.  The standard addresses connectors used for neuraxial applications.  These are intended to administer medications for anaesthesia procedures, remove cerebro-spinal fluid, and so on.  The 65-page document is a wealth of information.  It covers general requirements, dimensional requirements and performance requirementsin the body of the text.  Then the 10 (count them, 10!) Annexes delve into the details of test procedures, rationale and guidance, small bore and reference connectors, etc.  A 24 item Bibliography completes the document.

Why has AAMI CN6 been published?  Very simply to promote patient safety.  The benefits of standardizing connectors in a hospital or other healthcare setting to avoid errors which can sometimes lead to fatalities are clear.  As a prime proponent for healthcare and medical device safety, AAMI feels compelled to help industry achieve this worthy goal as soon as possible.

How can you get your copy of AAMI CN6?  Since AAMI standards are covered by the laws of copyright, you’ll need to choose an authorized distributor like Document Center Inc. for your purchase.  Use our webstore, www.document-center.com, to order online.  Here is the link directly to the order page for AAMI CN6.  Or feel free to contact our staff by phone (650-591-7600) or email (info@document-center.com).  We work with many companies in the medical device space and have tools available to make your documentation challenges easier.  Make us your Standards Experts!

 

ISO/IEC TS 30103 – Software Quality

ISO/IEC TS 30103, “Software and Systems Engineering – Lifecycle Processes – Framework for Product Quality Achievement,” has just been released.  It extends the work of ISO/IEC/IEEE 15288 (“Systems and software engineering – System life cycle process”), covering the issue of quality in projects for systems and software products and services.  It delivers you a systematic approach to quality, centering on the development of information items, their relationships, and consistency in the maintence and management of these items.

Why would you need to use ISO/IEC TS 30103?  Because it is a detailed specification on how to develop the process instances necessary to create your product and in so doing, achieve your quality goals.  And it will help you to develop, measure and evaluate how well you meet those goals as well.

What are the principles of this new technical specification?  The document states the following:

  • Localization of quality responsibility
  • Creation of process instance descriptions
  • Consistency with institutional knowledge
  • Maintenance of content consistency

What kinds of projects would you use it for?  The specification is geared for use during the development stage of the life cycle.  It is suitable for any project that involves the development, enhancement or re-engineering systems that include hardware, software and human interaction.  It is particularly helpful for those projects that are more complex or where the quality definition varies across the various application domains.

Why is ISO/IEC TS 30103 needed?  Achieving product quality over a product’s life cycle is a challenging task.  Often organizations find that decisions made early in the development of a product come back to haunt them later.  This technical specification provides you with a methodology for spotting potential gaps in identifying and applying relevant technical information at the developmental stage.

How do you get a copy of ISO/IEC TS 30103?  The document is covered by copyright law, so you’ll want to purchase your copy from an authorized distributor like Document Center Inc.  Go directly to our web store and search and order the standards you need at www.document-center.com.  Or use this link for the order page for ISO/IEC TS 30103.

Still have questions?  Contact our knowledgeable staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982, so make us your Standards Experts!