EN-60601-1-2 2015 for Medical Electrical Equipment is here!

EN 60601-1-2, “Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests,” has just been updated.  The new 2015 Edition is equivalent to the IEC 60601-1-2 Edition 4.0, upon which it is based.  The EN 60601-1-2 is part of the harmonized standards list for Directive 93/42/EEC.  While the 2015 Edition has not been officially adopted yet (published in the official journal), this should happen soon.

Speaking of dates, one question we often get asked here at Document Center is “When must my transition from the old edition to the new one be completed?”  For the EN 60601-1-2, the DOW (Date of Withdrawl of the previous edition) has been extended to 12/31/2018.  This is the date when all other national standards within the European Union (including the 2007 Edition of the EN 60601-1-2 and it’s corrigendum) must be withdrawn from usage.  You’ll also note that all publications of the European national adoptions (SS EN, DIN EN, and so on) for the new 2015 Edition should be completed by 3/18/2016.

Now, what is included in this new 2015 Edition of EN 60601-1-2?  Basically, the text from IEC 60601-1-2 Edition 4.0 has been adopted for use as an EN standard.  Some unique features include the addition of a ZA Annex.  This Annex states, “When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a normative reference to the parallel EN standard, as outlined below, including the foreword and the Annexes ZZ.”  Yep, you’ll need to be using the EN editions of the referenced documents…  And the Annex ZZ from EN 60601-1:2006+A1:2013 applies.

The EN 60601-1-2 also has it’s own Annex ZZ.  This describes how conformance to this standard meets the essential requirements of Directive 93/42/EEC.  There is a series of 7 notes that preceed the table Z.1.  These notes range from the basic disclaimer of the limits of the standard’s scope to the detailed risk management disclaimers of notes 3 and 4.  For those of you concerned about the impact of national legislation and other potential variants, note 5 requires that you confirm that such clauses are in compliance with 93/42/EEC yourself.

The Table Z.1 is the actual clause-by-clause review of the standard against the Directive.  This is a listing of the Essential Requirements of the Directive 93/42/EEC on the left and the corresponding clauses from EN 60601-1-2 that provide coverage for each.  Do note that not all essential requirements are addressed by this standard.

If you need a copy of the EN 60601-1-2 right away, the BS EN 60601-1-2 is currently available.  You can search for and order an authorized copy at our webstore, www.document-center.com.  Here’s a link directly to the order page for BS EN 60601-1-2.  Or contact our staff for more information by phone (650-591-7600) or email (info@document-center.com).  We expect other national editions to be available soon.

Why choose Document Center Inc. for your standards purchases?  Flexibility, great customer service, superior notifications, and a knowledgeable and responsive staff.  We have been working with standards, standards developers and standards users since 1982.  Make us your Standards Experts!

AHRI and Document Center Inc. sign Distribution Agreement for Standards

AHRI and Document Center Inc. have just signed a new distribution agreement for the AHRI standards.  This adds AHRI standards in both pdf single copy format and as multi-user subscriptions to Document Center’s rapidly expanding catalog.  For those of you in the air-conditioning, refrigeration, and heating industry, you’ll appreciate the extension of our services for the AHRI standards set.

What is AHRI?  AHRI is the Air-Conditioning, Heating and Refrigeration Institute.  The organization has a long history, starting with the Refrigeration Equipment Manufacturers Association and the Air-Conditioning and Refrigerating Machinery Association.  These two entities merged in 1953 to form the ARI, Air-Conditioning and Refrigeration Institute.  So many of you know this standards set as the ARI standards.

In 2008 ARI then merged with GAMA, the Gas Appliance Manufacturers Association, thus forming AHRI as we know it today.  The Institute maintains over 115 Standards as well as approximately 16 Guidelines (some are published both in inch-pound and metric formats).   And the number of these publications continues to grow each year.

You’ll also be interested to know that it is part of AHRI’s mission to promote HVACR Industry issues both at the U.S. federal level and with various states around the country.  This involves an active advocacy program as well as education, training and regulatory support.  AHRI considers the HVACR community to be an essential component for meeting energy conservation goals around the world.  In particular, it’s workforce training program is geared to help develop the 57,000 skilled workers needed for this critical industry.

Where does Document Center Inc. come into all this?  Here at Document Center we have a clearinghouse of standards from around the globe.  Our customers can use our catalog at www.document-center.com to search for and order standards from a wide selection of standards developing organizations.  The addition of AHRI standards in pdf format and as part of our Standards Online multi-user platform will be of value to our customer base and to the standards community at large.

We’re pleased to have AHRI join our family of standards developers.  The new agreement for AHRI and Document Center will mean your standards purchasing options have been expanded.  Here at Document Center we look forward to providing you, the AHRI standards user, with the services and formats you need when you’re making the standards purchasing decision.  Remember, Document Center Inc. has been working with standards since 1982.  Make us your Standards Experts!

IEC TR 60878 Updated – Graphical Symbols for Medical Practice Electrical Equipment

IEC TR 60878, “Graphical symbols for electrical equipment in medical practice,” has just been updated.  The new Edition 3.0 cancels and replaces the 2nd Edition from 2003 since it is a technical revision.  Since it contains new symbols and safety signs, you’ll want to get your copy of the new Edition if you use this standard.

The IEC TR 60878 is a bilingual edition, with text in French on the left and text in English on the right.  Only the pages with symbols have text in both English and French.  Should the technical report be released in an English only edition, please be aware that sometimes only the odd numbered pages would be included at the beginning and the end of the document.  This protocol can sometimes confuse users…

What is included in the IEC TR 60878?  The technical report is a compliation of graphical symbols used on medical electrical equipment.  So if you use a certain symbol and need to find related ones, it’s very easy.  Also, all these symbols have been developed using the drafting rules of ISO/IEC 80416.  They present symbol elements in a consistent manner so that they can be easily understood by your user population.  And they have been drafted in a way to make them different enough one from the other to avoid confusion.

This means that the bulk of the publication is actually pages of related symbols, then a discussion of each symbol and it’s meaning along with alphabetical indexes included at the end.   What symbols will you find?  Adjustable lower and upper limits, do not cover, non-sterile, “on/off” (push button), and power plug are just a few.  They are used for such products as patient monitoring, dental equipment, ultrasound equipment, nuclear medicine, active implantable medical devices and so on.

How large a publication is IEC TR 60878?  Currently Edition 3.0 clocks in at 288 pages.  Of course, you’ll need to get your copy of this new release from an authorized distributor like Document Center Inc.  Order at our webstore, www.document-center.com.  Or go directly to the order page for IEC TR 60878.  If you have additional questions or need information on multi-user access, 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!

TT-C-490 Amended – Chemical Conversion Coatings

TT-C-490, “Chemical Conversion Coatings and Pretreatments for Metallic Substrates (Base for Organic Coatings),” Revision F has just been updated with the release of Revision F with Amendments 1 and 2 interfiled.  The new 34-page federal specification is widely used throughout industry, so many of you will need this new edition.  Changes are extensive.  Get your copies now from Document Center Inc.

When is TT-C-490 used?  It covers processes, pretreatments, and pre-primer surface preparation for metallic substrates prior to coating applications.  Why?  To delay the onset of corrosion and to promote the adherance of primers.  It’s called out in many government contracts, including those issued by the DoD (U.S. Department of Defense.)

The new update states that changes are too extensive to allow for those black lines in the margins that are often used to identify areas where revisions have been made.  I will say that they’re correct — there are a lot of changes.  The scope has been expanded, the reference documents section has been revised, and so on.  Of particular note is the expansion of the toxicity clearance from strictly to the Army supply system to the Government supply system in general.  And of course, the migration from the MSDS to SDS reporting remains on track.

You’ll also be pleased to note that in this new edition of TT-C-490F, inspection responsibilities have been expanded to include both ISO 9000/IEC 17025 or NADCAP certified facilities.

Meeting the requirements of the military and federal specification system is essential in successfully fulfilling government contracts.  If you’d like help setting up a compliant documentation system to ensure that these documents are being used correctly in your organization, you’ll want to check in with us for more information on our Standards Online custom multi-user service.  Contact our staff via phone (650-591-7600) or email (info@document-center.com) for more information on how we can be of assistance to you and your compliance program.

Meantime, if you need a copy of the new TT-C-490 and want the no-charge notification service that comes with every Document Center purchase, go to our webstore at www.document-center.com.  Here’s a direct link to the order page for TT-C-490.  You’ll find our prices for government documents to be among the lowest around and our services to be the best!  Make us your Standards Experts.

New IPC-6012 Revision D – Rigid Printed Boards

IPC-6012, “Qualification and Performance Specification for Rigid Printed Boards,” has just been updated.  The new Revision D is available from Document Center Inc. in paper format, for pdf download, and as a CD Rom.  It replaces the now obsolete Revision C from 2010.

If you’re in the electronics industry, you probably know that this is the standard for the qualification and performance of rigid printed boards.  This can include single-sided, double-sided, multilayer and metal core boards.  You’ll get information on final finish, surface plating coating requirements, coductors, holes and vias, acceptance testing and quality conformance.  And it also includes electrical, mechanical and environmental requirements as well.

The new IPC-6012 Revision D is updated with new requirements for HASL coatings, alternative surface finishes, edge plating, marking, microvia capture and target lands, copper cap plating of filled holes, copper filled microvias and dielectric removal.   You’ll use it with IPC-6011 and also please note:  If you use IPC-6016, it has been replaced by the IPC-6012D as well.

And FYI:  There is also a new supplement that’s been released for the IPC 6012. This new IPC-6012-S, “Space and Military Avionics Applications Addendum to IPC-6012D,” is also available from Document Center Inc.

IPC, and by extension Document Center, offer you a wide range of options when it comes to purchasing your copy of the new edition.  Of course, the print edition remains the most flexible option in many cases, given the traditional portability of the paper format.  Your pdf and CD Rom options are normally single-user copies, meant for the use of 1 person on 1 computer.  Networking solutions need to be quoted separately.  And as an authorized distributor of IPC standards, Document Center honors all IPC prices as well.

You can go ahead and search for the IPC standards you need on our catalog page, www.document-center.com.  Or use these links to go directly to the order page for IPC-6012 paper format, IPC-6012 CD Rom format and IPC-6012 pdf format.   And here’s the links for the supplement: IPC-6012-S paper format and IPC-6012-S pdf format.  Questions?  Contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been providing folks like you with the standards you need since 1982.  Make us your Standards Experts!


ANSI’s efforts to make a difference in developing nations

ANSI, the American National Standards Institute, has been taking on some ambitious projects to improve the lives of those in developing nations.  First was the leadership role ANSI played in the improvement of cookstoves back in 2011.  Now, with the help of the Bill and Melinda Gates Foundation, it’s sustainable non-sewered sanitation systems.

The project was highlighted in the ANSI meetings during World Standards Week (WSW) last week.  It is intended to make a difference for a problem that results in approximately 1 million preventable deaths each year.  Unsanitary conditions from lack of sewage systems can be mitigated by the use of toilets that do not require traditional infrastructure, such as sewer, water connection, or electricity.   Additionally, they remove pathogens and cost less than 5 cents per use.

Why create standards for these non-sewered toilets?  First of all, standards will provide manufacturers with a common requirements for these “reinvented” toilets.  This in turn will allow purchasers to verify that minimal health and safety criteria are met.  And performance criteria can be compared from supplier to supplier.

What is ANSI’s role in the development of these toilets?  Like the ANSI leadership role in the development of clean cookstoves, the organization will be the secretariat for the project.  This means that ANSI will run the meetings and provide the logistics for the meetings and other work that’s involved in such standardization efforts.

What will ANSI get from this work?  In the case of the work with clean cookstoves, there’s a real benefit for much of the world’s populations (as well as the environment).  Open fires and traditional stoves are used by 40 % of the world’s population.  Net result?   4 million deaths a year, consumption of 500 million tons of non-renewable wood, and greenhouse gas emissions equal to that of 170 million passenger vehicles.  The new cookstove standards adopted by ISO provide a way to rate various options and to encourage the development of alternative fuels, etc.

Now with non-sewered toilets, the goals are much the same.  ANSI will provide leadership with the international standards community.  The deliverable will be standards for this emerging industry, promoting commerce and innovation so needed within the developing world.  And the Bill and Melinda Gates Foundation?  The organization has seen that there’s a need in developing countries for such technologies.  And that a standards-based approach can lead to long-term sustainable improvements world-wide.

It’s clear that ANSI is looking for ways to make a difference in this world.  The Institute is to be commended for the forward-looking leadership that makes these types of efforts possible.

Gaming the Standards System

Standards are predominately the domain of engineers and I often find that they are not as aware of the political aspects of standardization as they might be.  So many times people are surprised to find that gaming the standards system is quite possible.  Certainly, the situation with the deisel engined automobiles from VW makes us critically aware that not only is it possible to game the system, but it can be done on a remarkably large scale.

Here’s what.  I discovered very early into my ownership of Document Center Inc. that it’s possible to rig standards for one’s own benefit.  I had a customer who as a civilian had written a military specification.  The DoD procuring officer in charge of the document didn’t feel technically capable of writing it himself.  So he asked my customer to do it for him.  And guess what?  The customer cleverly wrote the specification for this small part in such a way that it would be economically unfeasible for any competitor to bid on supplying it to the government (he wrote a particular shape into the document).  Net result?  The customer’s company was the sole supplier in the U.S. for this item.

Here’s what.  The situation with Qualcomm, Nokia, and the GSM standard for cell phones is another example of gaming the standards system.  That particular situation was complex.  But the decision by regulators to favor one standard over another in a particular region for the benefit of a local company over a foriegn one is not all that unusual.  Gaming the system?  You bet!

So the thing about the VW situation that I really notice is that (as it is being reported in my paper, the Wall Street Journal), it is a situation that leads right back to the top.  Considering the change in top management as soon as the situation became public is very suggestive, wouldn’t you agree?  Meantime, the ISO 14001 environmental standard, to which VW is certified, states that compliance needs to be championed with management first.  Not exactly…  So here is a company that says one thing and does another.  And while it was working, hey, they were gaming the standards system!

What’s the phrase, “trust but verify”?  I am surprised that it took our California regulators to find such a blatent trick that allowed these cars to pass their tests and yet not deliver on their promise on the road.  What the heck has been going on in Europe?

Let me know what you think.  Is this a standards problem or a failure of ethics?


It’s World Standards Week!

It’s World Standards Week and I’m in Washington DC to participate in all the meetings and events hosted by ANSI.  Document Center Inc. is a sponsor of the U.S. celebration this year.  This is just one of the many ways that Document Center supports the standards community.

The celebrations will culminate with World Standards Day on Thursday October 1st.  The theme this year is “Standards – The World’s Common Language” and at the dinner event the winners of the World Standards Day paper will also be announced.

I had thought about submitting a paper, but I find that I’m more focused in on the areas where our goal of “one standard, one test, accepted everywhere” has still not been reached.  So for the next three days, I’ll be blogging on the three things I’m obsessed with this week!  You’ll get my humble opinions on Gaming the Standards System, on The New Approach – Is it working?, and on Compliance – Where do we go from here?

In the meantime, I am glad that the standards community gathers in locations around the world during this time.  I’m a big promoter of the standards system and am always thankful that we have developed such a structure to help keep us safe and to promote the free flow of beneficial goods and services.  I hope you’ll take a moment out this week to reflect on the many successes standards have had over the years and how they help make your life better!

More Quality Updates – EN 9101 for Aerospace

EN 9101, “Quality Management Systems. Audit Requirements for Aviation, Space, and Defence Organisations,” has been updated!  The new 2015 Edition has been adopted for use in the European Union and is available now from Document Center Inc.  We’ll find that there’s a number of national editions, some released and some pending.  And we’ll discuss the status of the U.S. Edition of the standard (AS 9101) as well.

Why are EN 9101 and other similar standards being revised?  The 2015 Edition for ISO 9001 is prompting modifications of the “children” standards that are tailored for specific industries like aerospace.  Basically this means that the changes to the ISO 9001 now will trickle down through the many variants that have been generated for targeted audiences.

Which editions of the EN 9101 2015 Edition are available?  Currently the BS EN 9101 2015 Edition is published.  It’s available in paper format for $318.00.  The SS EN 9101 2015 Edition is available in both paper and pdf format, priced at $162.82 a copy.  The DIN EN 9101 2015 Edition is not released yet.

What about the AS 9101?  The U.S. publication of this standard is under revision right now.  The committee is working on a new Revision F which will replace the current Revision E from 3/2014.  There is no firm date when the new release will be available.

Want to get a copy of any of these editions?  Head directly to www.document-center.com and order from your authorized distributor, Document Center Inc.  You’ll contact our staff directly for the purchase of the SS EN 9101.  You can reach them by phone (650-591-7600) or email (info@document-center.com).  Here’s the order page for the BS EN 9101.  Other editions will show up in our catalog as they are updated.

Stay tuned!  There are sure to be other standards in the ISO Quality set that will be updated as well, now that the ISO 9001 2015 has been released.  If you’d like to have a spot to review the situation, check out our ISO 9000 store at ISO9000.document-center.com.  All the ISO quality standards are listed, including information on the latest revision.  It’s an easy way to see what the status of your quality standards are.  And ordering any new editions is a snap!

Remember, Document Center Inc. has been helping standards users like you since 1982.  Make us your Standards Experts!

ISO TS 22317 and ISO TS 22318 – Business Continuity Management

ISO TS 22317 and ISO TS 22318 have just been released.  Each addresses a different aspect of BCM, Business Continuity Management, in support of ISO 22301.  BCM is used basically for supplier management, allowing for a reliable flow of raw materials and component parts into an organization.  Let’s take a look at them one at a time.

ISO TS 22317, “Societal security – Business continuity management systems – Guidelines for business impact analysis (BIA)”

This new 1st Edition provides you with guidance on how to set up a business impact analysis (BIA) process.  It’s in support of ISO 22301, “Societal security – Business continuity management systems – Requirements.”

The BIA process provides you with the tools to set up a risk analysis review of supply chain requirements and the consequences of any disruptive incident on your company.  It will help you identify factors in your supply chain that can affect your production.  And it will help you understand how your supply chain affects your legal and regulatory obligations.

Can this process help any organization?  You bet.  There’s no need for a specific size, mission, or organizational structure when using this scheme.  It’s a great tool for all those responsible for protection and management of the supply chain.

ISO TS 22318, “Societal security – Business continuity management systems – Guidelines for supply chain continuity”

ISO TS 22318 actually supports both ISO 22301, as above, and ISO 22313, “Societal security – Business continuity management systems – Guidance.”  This  technical specification provides you with the guidance you need to understand the principles of BCM and apply them.  It helps you get a grip on the challenges of supply chain continuity (SCC) in the global economic environment.

ISO TS 22318 can be used for the procurement of both goods and services.  It discusses why you should be implementing a SCC system,  what your analysis of your supply chain should include, the strategies you can use, how to evaluate your performance, and how to manage a disruption.  There’s also a 7-item bibliography that references other standards of interest.

If you need any ISO standard, you’ll want to use an authorized ISO distributor as your source.  Document Center Inc. has been selling the ISO standards since the 1980’s and is a supplier you can trust.  You have a choice of formats and for payment with Document Center, as  well as our superior notification service provided free with each order.  Just go to www.document-center.com and search for and purchase any standard you need.  Or use this link for the ISO TS 22317 order page or this link for the ISO TS 22318 order page.

Want to set up a multi-user subscription service for your company so your employees can access their standards 24/7?  Contact our staff for information on Standards Online.  They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!