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New MedDev and In Vitro MedDev Regulations approved in Europe

The much-anticipated updating of both the Medical Device Directive (93/42/eec) and the In Vitro Medical Device Directive (98/79/ec) have finally been formally approved. The next step for the new MedDev and In Vitro MedDev Regulations is publication in the Official Journal. This is expected in early May. The official transition period should begin in June. The new Regulations should be fully in force in three years for Medical Devices, and in five years for In Vitro Medical Devices.

The new MedDev and In Vitro MedDev Regulations have been in process for the last 8 years. This is the first major revision of the Directives issued in the 1990’s.

Changes to the Medical Device Directive appear to be primarily a modernization of the original rules. You can expect to see best practices from existing Commission guidance to now be included. During your transition, plan to implement requirements that have been the subject of recent harmonization. This is particularly true in the areas of risk management and clinical evidence. Expect to tighten up your control over your supply chain as well.

In the In Vitro Medical Device arena, you have a longer timeline for compliance with the new rules. This implies that there are still areas needing clarification during the “secondary legislation” phase. That said, the Regulations are a major update for the rules for these devices. The use of 4 risk-based classes, with differing levels of requirements, will mean more extensive use of Notified Bodies during the certification process. Performance evaluations, distribution requirements and “responsible person” requirements will all impact your certifications.

Once the 2 new regulations are published in the Official Journal, the clock is ticking. The official text of the new regulations will be available at that time (likely early May). Please send us an email (info@document-center.com) if you need copies. Use “New MedDev Regs” as the subject and we’ll reply with your complimentary copies as soon as they are issued.

If you need assistance with the many standards on the Harmonized Lists for these two Regulations/Directives, please let us know. You can search for and order standards at our webstore, www.document-center.com. But many of our customers do have questions regarding which editions to choose, transition times, and so on. Don’t hesitate to reach out to us. We’re your Standards Experts!

Incorporation by Reference (IBR) News

The issue of Incorporation by Reference (IBR) of standards into the U.S. Code of Federal Regulations (CFRs) has generated a number of copyright issues. Now with a recent ruling by the U.S. District Court for the District of Columbia, some clarity has been offered.

At issue is the very concept of copyright for standards documents referenced in U.S. regulations. There has been an on-going debate about copyright in these instances. Should IBR standards be freely available or should the rights of the copyright holder (the standards developer) be upheld?

On one side of this debate stands an organization called Public.Resource.org, Inc. which has been posting IBR standards on the Internet. Challenging the “freely available standards” stance, ASTM International, ASHRAE (the American Society of Heating, Refrigerating and Air-Conditioning Engineers) and NFPA (the National Fire Protection Association Inc.) are on the other. The battleground was a lawsuit brought by these Standards Developers (SDOs) against Public Resource for posting standards without permission and without compensation.

Last week, the court ruled in favor of the SDOs. This means that IBR does not move referenced standards into the public domain. Copyright protection continues to be in force. This may mean free “read-only” access or it may mean the standards need to be purchased. Each SDO continues to be the decision maker with regards to distribution.

Why is this considered a victory by SDOs? Sale of publications in many cases is a significant part of the funding for these non-profit organizations. IBR standards can be some of the most frequently used documents in their catalogs. The potential lost revenue represents a legitimate challenge to the way standardization is funded. As ANSI (the American National Standards Institute) notes, “The ruling supports ANSI members and the standards ecosystem, and enables the plaintiffs to continue to develop high-quality voluntary consensus standards that support federal, state, and local agencies.”

The standards community as a whole is grateful to these three associations for taking on the legal challenge presented by Public Resource and others of its kind. Copyright protection requires constant vigilance. However, many associations do not have the funds available to take on such a case. Leadership by ASTM, ASHRAE and NFPA has been a boon to the community as a whole.

Standards are included in our regulations as best-practice solutions for health, safety, and quality requirements. Having the two systems work in harmony is essential — one being the voluntary standards system and the other the regulatory framework for the enforcement of our laws. I expect this ruling to provide the legal precedence needed for creating a stable legal footing regarding copyright and IBR for the standards developing community.

IPC 7711 & 7721 Updated for electronic assemblies

IPC 7711 & 7721, Rework, Modification and Repair of Electronic Assemblies, has been updated. The new Revision C is available from Document Center Inc. now in a variety of formats. It is used by companies that repair, supply materials for and rework electronic assemblies. You’ll use this standard for the procedures for reworking, modifying, and repairing these products.

The new IPC 7711 & 7721 Revision C contains the latest best practices for the industry. Common procedures and general information on the topic are provided. The new edition contains a number of important changes. IPC highlights the following updates:

Change procedures incorporated to the main document
Additional BGA – CSP Removal Procedure
Additional BGA – CSP Installation Procedure
Graphics Updated
Individual procedures controlled by review date

Document Center Inc. has been selling the IPC standards for many years. The IPC 7711 & 7721 is one of our consistent best sellers in the IPC publication collection. Why? Companies that do any repair or rework of electronic assemblies rely on this standard for maintaining their good workmanship requirements.

If you need a copy of this new issue, it’s available at our webstore www.document-center.com in a number of formats. To take a look and choose what’s going to work best for you, here is the results page for IPC 7711 & 7721. Please remember that all electronic formats (Pdf delivery and CD Rom format) are non-printing. If you need a printed copy, you’ll need to purchase the standard in paper format.

You may have more questions about this document. Or you may want to know more about the many other products and services we offer to standards users like yourself. Get in touch with our knowledgeable staff by phone (650-591-7600) or email (info@document-center.com) for the assistance you need. We have been selling standards since 1982 and make a point of educating our staff on the nuances of this type of compliance information. Make us your Standards Experts!

3 New IEC Nanotechnology Specs Released

There are 3 new IEC Nanotechnology Technical Specifications and those of you in the industry will want to get copies. One is a vocabulary document (IEC TS 8004-9). The other two address Nanomanufacturing (IEC TS 62607-3-2 and IEC TS 62607-4-5). We’ll take a look at each of them one at a time.

IEC TS 80004-9, Nanotechnologies – Vocabulary – Part 9: Nano-enabled electrotechnical products and systems

This new technical specification has been released to help those of you working on the synthesis of nanomaterials and composites. The uses of these materials are being explored for high energy storage batteries, for example. Since the field is growing quickly, there’s a need for this terms and definitions document. Some examples of terms addressed include NEMS (nano-electromechanical system) and OE (organic electronics). It should be used by folks in the field of nanotechnologies and the production of electrotechnical products and systems.

IEC TS 62607-3-2, Nanomanufacturing – Key control characteristics – Part 3-2: Luminescent nanoparticles – Determination of mass of quantum dot dispersion

Luminescent nanoparticles are finding their way into a number of applications, including medical diagnostic devices, lighting, and “smart” glass. This is achieved by the use of “quantum dots,” the physical particles themselves. Of course, these dots need to be synthesized and tested for stability. This 18-page technical specification addresses the technical details of determining the mass of a sample quantum dot dispersion. Measurements are taken after the impurities and sufactant ligands are removed by heating to high temperatures.

IEC TS 62607-4-5, Nanomanufacturing – Key control characteristics – Part 4-5: Cathode nanomaterials for nano-enabled electrical energy storage – Electrochemical characterization, 3-electrode cell method

This 26-page technical specification is also a highly technical document for nanomanufacturing. It too focuses on energy systems, particularly batteries for electric vehicles. Of particular interest is the use of electrodes made from nanoscale composites. The document specifically provides a methodology for characterizing the electrochemical properties of new cathode nanomaterials. It is based on a 3-electrode cell method. This will help you compare different types of cathode nanomaterials (like lithium iron phosphate – LFP) during your developmental stages.

Where do you get your IEC Standards? IEC directs you to use authorized distributors like Document Center Inc. You can search for and order from over 1 million documents at our webstore, www.document-center.com. Or if you need additional information or assistance, just get in touch with our staff. We can be reached by phone (650-591-7600) or email (info@document-center.com).

Document Center Inc. also has an array of supporting services to help you collect, maintain and distribute the standards your organizations needs. Check in with us about notification, reporting and access options. We have been working with Standards since 1982 and IEC since the 1990’s. Make us your Standards Experts!

EN Adoptions of IEC Standards

I recently had a question about the EN adoptions of IEC standards. The question was basically, “How can I know when an EN adoption of an IEC standard is identical to the original IEC document?” This is a valid question since the EN adoptions may or may not include changes from the source material.

Of course, since all EN ISO adoptions are labeled that way (i.e., “EN ISO 9001”), questions come up frequently about why the IEC adoptions are not the same. I have always answered that since the IEC adoptions are not necessarily identical to the source, the same numbering protocol has not been used. While true, most customers are not very pleased with this answer!

Well, good news for all you standards users out there! CENELEC and IEC have signed a new agreement that will change the way that the adoption process is handled. Here are some highlights from the new Frankfurt agreement last October.

Currently 80% of the EN adoptions of IEC standards are identical to the source material. From now on, IEC documents that are adopted without changes will be labeled “EN IEC.” This will be just like the ISO adoptions. So when you see a new release numbered “EN IEC,” you’ll know the IEC content has not been changed.

Further, CENELEC and IEC are striving to harmonize an even greater number of standards. So there should be more European adoptions that are identical to the source IEC standards. Organizations that rely on these documents for their electronic products (now almost 20% of all global trade) are sure to be pleased.

National differences in standards make for confusion and expense. And they detract from a region or country’s competitiveness. This is good news indeed that Europe is working towards a reduction in these types of variations.

The lack of clarity in the current situation has been a hindrance to global usage of the EN adoptions. It has caused confusion in the marketplace when a product meets the requirements of the EN adoption. Folks just don’t know if meeting the EN edition is the same as meeting the IEC edition. Over time, the new protocol will make it easier to understand equivalencies.

The last time the EN adoptions of IEC standards were administratively addressed was back in 1996 in Dresden. Times have changed and industry is pushing for more harmonization as markets continue to globalize. Expect to see the new system implemented soon. And don’t be surprised when some of the numbers of the standards you frequently use are updated. Now that you know what the revision means, you’ll be glad to see it happening!

Meantime, if you have any further questions, don’t hesitate to get in touch. Our staff will be happy to work with you so you can understand the migration path of your compliance information. Reach out to us by phone (650-591-7600) or email (info@document-center.com). And go ahead and search for and order the standards you need at the Document Center Inc. webstore, www.document-center.com. We’ve been working with standards for over 35 years. Make us your Standards Experts!

Further thoughts on Brexit and BS EN Standards

Recently I blogged about the Brexit and BS EN Standards. As time goes on, the likelihood of a “soft Brexit” seem to be diminishing. So my initial analysis certainly looks less likely.

After the Brexit vote, there was talk of Britain taking the same path as Norway and Switzerland. That is, Britain would choose to remain part of the European Economic Area (EEA) while exiting the EU itself. This would certainly be the least disruptive option. However, with many of the statements that Prime Minister May has made, this path seems to be out of the question now.

The most recent positive news suggests that May is interested in retaining some economic ties to the EU. There is talk of adopting the entire body of EU laws and regulations. This would mean that the EN standards would remain in force in the UK after an EU exit.

However, the possibility of the British Standards Institute (BSI) remaining on as the publisher of the official English language editions of the EN standards is questionable at this point. Since Britain would not be officially part of the EU or EEA, the right to publish official documents does not seem possible in my eyes. There is no doubt that the institution would continue to audit for compliance. They would simply be assigned those rights by a Notified Body still within the remaining EU.

Many of our Document Center Inc. customers have invested in extensive collections of BS EN standards. Further, those editions are often referenced in company documentation. Moving forward, you may want to rethink this policy if you are in this situation. There are English language editions of the EN standards published by other national standards bodies. These editions have the same weight as those from BSI and are identical except for the cover sheets.

If you are uncertain of what to do, check in with your certification body first. Then, get in touch with us for suggestions of other options for your EN standards purchases. You can reach our staff by phone (650-591-7600) and email (info@document-center.com). While immediate action is not required, development of a long term strategy is certainly be advisable.

World Standards Day 2016

Today we’re celebrating World Standards Day here in the U.S. In most countries, the date is usually the 3rd Thursday in October. However ANSI takes advantage of the event to schedule a week-long series of meetings for the various standards constituencies it represents. So this year the date of the U.S. World Standards Day is today, the 27th.

The theme for this year’s World Standards Day is “Standards Build Trust.” Some regular activities include an international competition (usually a paper, but this year a video). And here in the U.S., there is also a paper competition sponsored by SES, the Society for Standards Professionals.

For those of us in the standards business, standardization does represent a methodology for achieving consistency and safety in the products and services we use every day. Standardization underpins commerce, creating an inherent confidence in the functionality of the products we buy. And having “Standards Build Trust” as the World Standards Day theme reenforces this basic concept.

However, certainly within SES, there has come to be a movement towards acknowledging the supporting role certification plays in making the greater goals of standardization a reality. Peter Unger of the American Association for Laboratory Accreditation has been a champion for this viewpoint. The introduction of the testing and certification into the SES agenda has provided a fresh look at the interaction between standards and the realities of the marketplace. “Trust but verify” seems to be the mantra here.

I know that many organizations find additional 3rd party testing to be combersome at times. However, I noticed in a Wall Street Journal article the other day that the Samsung phones currently undergoing a recall were only tested in-house. This suggests that such testing is not only appropriate to meet compliance requirements, but also to provide outside validation of design and manufacturing decisions prior to the release of a product.

Be that as it may, there is no doubt that the standardization community is growing. With the addition of players from around the world, it’s clear that the global community deeply understands the value of standards. Face it, we live on just one planet and the needs of one are really the needs of many. Here at Document Center Inc., we are proud to be a part of that “hidden infrastructure” that makes that world a safer, more integrated, and sustainable place.

ANSI/ASSE Z9.1 2016 Released

ANSI/ASSE Z9.1 has been updated. The new 2016 Edition is titled “Ventilation and Control of Airborne Contaminants During Open-Surface Tank Operations.” It is available now from Document Center Inc. You can get a copy in either paper format or for pdf download. The 2016 Revision replaces the previous 2006 Edition, which is now obsolete.

ANSI/ASSE Z9.1 provides you with guidelines for the control of health hazards resulting from open-surface tank operations. There are many industries that employ open-tanks. Such operations include washing, dyeing, coating (including electroplating), and so on. What are some of the hazards involved in these operations? Appendix A gives you information on potentially toxic contaminants. The use of protective devices required by the standard, including ventilation systems, will protect the health and well-being of tank workers.

ASSE, the American Society of Safety Engineers, focuses on worker safety issues and requirements for the protection of workers. The ANSI/ASSE Z9.1, like many safety standards, provides minimum criteria and can be adapted to the needs of the user. The introduction notes that when codes are more stringent than the standard, the regulatory requirements should be applied.

Also note that the ANSI/ASSE Z9.1 is “auditable.” The Appendix B is an audit form that can be used to confirm compliance with the standard. It is a series of statements, numbered to refer to the specific sections in the standard. A space for checking off compliance for each item is included.

The committee has give no exact information on the changes in this 2016 update. However, I will note that the standard is in a two-column format. The requirements of the standard are presented in the left-hand column. Additional clarifying information is provided on the right.

If you have open-tank operations at any of your facilities, you’ll want a copy of this new revision. You can search for and order standards at the Document Center Inc. webstore, www.document-center.com. Here are links to the order page for ANSI/ASSE Z9.1 in paper format and the order page for the ANSI/ASSE Z9.1 for pdf download. Document Center Inc. is an authorized distributor of the ASSE publications.

Perhaps you have additional questions or want to order directly with our staff. Reach us by phone (650-591-7600) or using email (info@document-center.com). We have been working with standards since 1982. You’ll find our staff to be knowledgeable about the standards you use. And we have a broad spectrum of products and services to support your compliance requirements. Make us your Standards Experts!

What’s happened to IPC Kits?

IPC, the Association connecting Electronic Industries, has discontinued the sale of “kits.” These IPC Kits were a combination of a paper copy and CD Rom copy of any given standard. As part of IPC’s move to stop distributing the IPC standards on CD Rom, the kits have been the first to go.

Moving forward, you’ll be able to get your IPC Standards from Document Center Inc. in both paper format and for pdf download. Site licensing is also available.

One thing to remember with the electronic copies of IPC standard is the suppression of the print functionality. IPC pdf copies are “read-only” and cannot be printed. Should you need a printed copy of any IPC standard, you’ll need to purchase it.

This supports a tenet of copyright law that standards users sometimes don’t understand. The format of the publication you purchase is the only format that is available to you. It is illegal to take a copyright document in one format and transform it into another. So if you purchase a paper copy and plan to scan it into your network system, you’re actually breaking the law. However, for most of the single user pdf standards sold by Document Center Inc., your license will authorize both the use of the file by 1 user on 1 computer and the right to print 1 paper copy. IPC is one of the few associations that we represent which does not permit the printing of a paper copy from the pdf file.

Here at Document Center Inc., we have noticed that many organizations are moving away from CD Rom distribution. The format is problematic for copyright owners — illegal distribution can become an issue. So it is not surprising that IPC is moving away from the practice. Indeed it was one of the last associations to rely heavily on this media.

If you need any IPC standards, please search for and order them at our webstore, www.document-center.com. We are an authorized distributor and can assist you with any questions you may have. Document Center Inc. has been selling standards since 1982 and has been on the web since 1993. Make us your Standards Experts.

Are IETF Standards Free?

Are IETF Standards Free? This is the third standards development model I am reviewing as part of my presentation at the SES (Society for Standards Professionals) Conference in Denver next week. As SDOs (Standards Developing Organizations) consider distribution options, understanding models that do not charge users for standards is important. And in my opinion, the IETF (Internet Engineering Task Force) model is the only one where standards are really free!

In this discussion, I will really simplify the IETF standards process in order to make my points. But if you are interested in the organization, their mission, and their real standards development protocol, you need to take a look at two of their web pages. The first is the “Getting Started in the IETF” page for newcomers to the IETF. The second is the “The Tao of the IETF: A Novice’s Guide to the Internet Engineering Task Force.”

The IETF is not a traditional standards developing organization. It does not have dues and participation is free (except for attendance at any of the 3 annual meetings which do have a fee). Documents generated by the IETF are called RFCs (Requests for Comments). Some become standards, many don’t.

RFCs can be authored by a single individual or by a group. Usually they are proposed within the structure of one of the many IETF working group. Discussion may ensue, with commenting and revision being an essential part of the process. A draft that has been through a number of updates may then be considered for adoption as an RFC. Eventually, some RFCs are elevated to the status of BCPs (Best Current Practices) and some become Standards (STDs). To learn more about this, take a look at RFC 2026, “The Internet Standards Process – Revision 3.”

All RFCs are freely available on the Internet. Of course, there are certain quirks that you need to be aware of. An RFC that has been replaced with a newer revision will not have any indication that it is out-of-date. You need to learn how the documents are kept and where to search in order to make sure you get the latest edition of a standard.

Also, you can imagine that over the years there have been plenty of attempts to create RFCs for topics that are of low interest to the community or attempts to derail Working Group projects. So there are protocols in place to make sure that the IETF stays focused on areas where consensus is important to the development of the Internet.

There are some things to note when you look at the IETF, their publications, and their processes. Because the group deals with the Internet, technology tools that make collaboration and consensus possible at a distance have been adopted by the IETF from the very beginning. By relying heavily of open source tools and protocols, the group keeps costs to a minimum.

Also, since the work is highly technical in nature, participants really are “birds of a feather.” And since all work is done on a volunteer basis, this usually means that only those directly involved with a particular aspect of Internet technology will be part of the appropriate working group.

How does this model differ from the traditional SDO protocol? The constraints of “good standards development practices” as typlified by ANSI protocols make administration of the standards authoring process essential. The IETF model does not meet ANSI requirements. Right out of the gate, the need for due process, wide participation in authoring, and maintenance over the lifetime of the standard creates challenges the IETF does not have. Traditional standards are expected to be reviewed once every 5 years. Revision is often necessary. All these things take money.

Are IETF Standards Free? As you can see, the IETF RFC process and distribution practices are indeed without formal costs. The IETF is an unusual and unique organization in the world of standards developers. Yet this extraordinary model for consensus and documentation does offer other SDOs an opportunity to look at an entirely different way of operating. Over time, there is no doubt that some of the IETF practices will be adopted by the traditional SDO community.