IEC 62366-1 Corrigendum

A new Corrigendum 1 has been released for the IEC 62366-1 Edition 1.0.  This standard is titled “Medical devices – Part 1: Application of usability engineering to medical devices.”  It is a widely used standard in the medical device industry.  But what exactly does this new Corrigendum do?

Many of our customers have questions when a corrigendum is released for an international standard.  So let’s take a look at what a corrigendum is and why it is issued for a given document.

Basically, a corrigendum is a change notice.  Similar updates are issued for other standards as errata, changes notices, and so on.  This type of change is too small to warrant an amendment.  But it is a change that affects the technical content of the publication.

You will find the true definition of a technical corrigendum in the ISO/IEC Directive 1.  These directives provide you with the administrative information for understanding the standards process.  They also define many of the document types ISO and IEC use.

Some things to note about a technical corrigendum.  It is issued when the change has a material affect on the techical content.  So it will always address an error or ambiguity that could “lead to incorrect or unsafe application of the publication.”   And it is not usually issued for a publication that is over 3 years old.

Now to the technical corrigendum for IEC 62366-1.  This correction sheet has been issued because of an error in numbering the references to a particular paragraph within the standard.  And it’s true, using the  wrong paragraph can lead to errors.  So the change fits the requirements for issuing a corrigendum.

There are 2 sections of the standard that have been affected by this inadvertent error in referencing,  Section C.1 (General) and Section C.2.4 (Risk control).    Your new corrigendum will give you the correct information.  You should keep the corrigendum with the document it affects.  And you might also like to make “pen and ink” changes to the body of the document so there’s no change of confusion.

How do you find out when a corrigendum has been issued?  Rely on Document Center Inc.’s notification service.  We track all components of the standards we sell.  And our notification service provides you with timely emails when changes to your collection have been made.  As I have noted above, technical corrigenda provide you with information the committee deems to be critical to the correct use of the standard.  You will want to make sure that when a corrigendum is issued for any of the standards you use, you are informed and get a copy promptly.

Just get in touch with our staff to get your copy.  You can  reach us by phone (650-591-7600) or email (  We are happy to help you understand the standards you use, how they are issued, and what you need in order to be current.  Make us your Standards Experts!

ISO/IEC 17826

ISO/IEC 17826, “Information technology – Cloud Data Management Interface (CDMI)”, has just been released.  The new 2nd Edition is the adoption of the SNIA (Storage Networking Industry Association) CDMI publication version 1.1.1.   It replaces the 1st Edition from 2012.  This 1st Edition was originally authored by SNIA as well.

SNIA is a consortium, with voting and non-voting members from across the networking community.  The CDMI standard was written specifically for application developers who are implementing or using cloud storage.  After the document was accepted and published by SNIA, it was presented to JTC1 (the joint technical committee 1 of ISO and IEC) for adoption.  So the ISO/IEC 17826 is a PAS, or publicly available specification.  This is not an uncommon route for a consortium standard to take.

The ISO/IEC 17826 is a lengthy document, coming in at 282 pages.  In many ways, the structure of the document is the same as many ISO/IEC software standards.  There are scope, referenced documents, and terminology clauses to open the material.  Next “conventions” are reviewed.  These are the use of various fonts and formats introduced for clarity.  Then an overview of cloud storage itself is provided.

Then the document gets right into the technical material.  Areas covered include basic cloud storage, the CDMI core, Advanced CDMI, and Annex A on extensions.  A 10-item bibliography completes the publication.

One concern that often accompanies standards of this type is the issue of patents and other intellectual property issues.  In this case, SNIA does provide for the use of the contents of the standard in a permission statement at the beginning of the publication.  Here the extent to which you can use the document and its text, charts, tables and so on is clearly spelled out.  And a license for the use of the code fragments, samples, etc. is also provided.  Those of you who are familiar with law suits concerning the use of various software code (like Java) will be relieved to see this statement.

Cloud computing and storage have become an essential part of the modern computer era.  It’s software standards like the ISO/IEC 17826 that provide us with the unseen foundations of our everyday activities.  Without these detailed guides on proper protocol the industry would not be able to move forward as fast as it has.

If you need a copy of this or any other standard, go to the Document Center webstore at  You’ll use it search for and order from our catalog of over 1,000,000 documents.  Here’s a link to the order page for ISO/IEC 17826 for your convenience.  It’s available for purchase in both paper format and for pdf download.

Of course, you may prefer to have company-wide cloud access to the publication!  Contact our staff to find out more about our Standards Online enterprise solution.  We can be reached by phone at 650-591-7600 or by email at  We’re based in Silicon Valley and have been working with standards since 1982.  Make us your Standards Experts!

ISO 37101 – Sustainable Cities

ISO 37101, “Sustainable development in communities – Management system for sustainable development – Requirements with guidance for use,” has just been released.  This new standard provides communities with a management system to foster sustainable development.  It covers the basics of quality management specifically for this task.

What’s involved in implementing ISO 37101?  As a management standard, ISO 37101 lays out a series of requirements.  It supports the quality system based on Plan-Do-Check-Act (PDCA) model.  Once you’ve defined your desired sustainability results, you’ll use “Plan” to create objectives and processes to deliver your goals.  You’ll use “Do” to implement these objectives and processes.  You’ll use “Check” to monitor and measure the results of your implementation.  And you’ll use “Act” to make improvements and foster even better results.

ISO 37101 is a conformity standard.  As a city, if you implement the requirements of the standard you can be certified as an “ISO 37101” compliant community.  So if you would like tangible proof of your efforts at creating an environmentally friendly community, this is one path you can take.

Like other conformity standards, ISO 37101 provides you with detailed information on context — the process of understanding the needs and expectations of what’s called “interested parties,” your citizens and others.  This section of the standard is a prelude to your “Plan” phase, with guidance on the various issues you should be considering and the purposes of this management system itself.    You’ll also get a  section on leadership, essential to the successful deployment of any system of this type.

Section 6 covers planning, which addresses both actions based on risks and opportunities and the objectives you’ll be defining.  Section 7 focuses in on support — the resources you’ll need for implementation.  Section 8 is on operational issues.  Section 9 reviews performance evaluation, including audits.  And Section 10 provides you with tools for improvements.

There are two additional informative Annexes.  Annex A discusses the maturity matrix.  This is a table that reviews various sustainability “purposes” and shows you how an organization progresses in that criteria over time.  Annex B is on the mapping of issues, indicators and metrics. It provides you with a table on the relationship of 3 standards, ISO 37101, ISO 37120 on indicators for city services and quality of life, and ISO/TS 37151 on smart infrastructure.   A 28-item bibliography completes this document.

This standard is a must for all those involved in smart city and other civic sustainablity initiatives.  You’ll want to get your copy from an authorized ISO distributor.  Here at Document Center Inc., we’ve been working with ISO standards since the early 1990’s.  Search for and order your standards with confidence at our webstore,  Here is a direct link to the order page for ISO 37101 for your convenience.

Some of our customers choose our Standards Online subscription service in order to gain cloud access to the essential standards for their businesses.  If this is the solution for your organization, please contact our staff for more information.  You can reach them by phone at 650-591-7600 or by email at  Remember, we do more than just sell standards and we have a number of services and products of real value to your organization.  Make Document Center your Standards Experts!


Standards and Copyright

I’ve been asked to participate in a session at the upcoming SES (the Society for Standards Professionals) convention in Denver next month.  The session will be on Standards and Copyright, primarily from an SDO (standards developing organization) point of view.  Of course, issues facing SDOs are issues facing the standards using community as a whole.  In preparation, I’ll be reviewing some of the material I’ll cover here in my blogs to help organize my thoughts prior to the meeting.

Of course, standards have always lived in “limbo.”  U.S. federal level standards (authored primarily GSA and DoD) have been without copyright since their inception.  On the other hand, industry standards have always been covered by it.  This mixed situation has led some standards users to believe that this type of technical information can be used and shared at will.  I remember one engineer telling me that an ASME standard was not covered by copyright.  I pointed out the copyright notice inside the front cover.  He said, “They don’t mean that.”  Like heck they don’t!

So what was previously a problem underneath the surface has really taken center stage.   Previously non-compliance occured first at the photocopier, the microfiche reader, and then with unauthorized distribution of CD Roms.  You had to go looking to find illegal use of standards.  Now the Internet makes the dissemination of information easy and commonplace.  Indeed, I find myself frequently in the role of “pirate hunter,” finding unauthorized standards stores online.

An additional factor impacting the discussion is the reliance of many SDOs upon the sale of the standards documents themselves for revenue.  Standards just don’t write themselves.  The stringent procedural requirements of, say, meeting ANSI protocol costs money.  None-the-less, there are also SDOs changing their business models to reflect the desire to “make information free.”

Protection of IP (intellectual property) rights can, in my mind, be divided into 2 challenges.  The first is the thievery of the property itself.  This is manifested by things like counterfeits, unauthorized posting of documents on the internet, and standards stores that sell unauthorized copies of documents.  The second is the movement to make standards available for free.  This is a common discussion when issues of IBR (incorporation by reference) of standards in regulatory and legal documents.

When dealing with standards and copyright, SDOs are faced with a situation that must be addressed.  Either they react with fear and move to the sidelines or agressively meet the challenge in order to be part of the solution.  Certainly, the first step is to educate oneself about the current reality, the next is to find others in a similar situation.  The SES session on copyright is intended to help any SDO start to get a handle on both the challenges and on a variety of solutions that are being tested right now.  If you’re a standards user or developer, I hope you’ll attend.

ASTM E1417/E1417M-16

ASTM E1417/E1417M-16, “Standard Practice for Liquid Penetrant Testing,” has just been released.  This new 2016 Edition replaces the previous 2013 Edition, which is now obsolete.  Just like the new update for the ASTM E1444/E1444M, the changes reflect the addition of a new ASTM standard in the referenced document section.

I’ve blogged about the ASTM E1417/E1417M a number of times.  It is a popular ASTM standard here at Document Center Inc.  It can be used on both nonporous metal and nonmetal components.  It’s applicable for finding discontinuities, like a lack of fusion, corrosion, cracks, laps, cold shuts and porosity, that are open or connected to the surface of a component under examination.

The scope paragraph states that this standard practice “establishes the minimum requirements for conducting liquid penetrant examination.”  This means that you can certainly call out more stringent requirements if you need to, but the ASTM E1417/E1417M is the baseline for viable results.   The standard provides you with information on the various cleaning methods, liquids that can be used for testing, examination methods, reporting requirements and so on.  It also notes the personnel qualifications necessary for those performing the examination itself.

The changes in the ASTM E1417/E1417M-16 have been primarily generated by the addition of a new standard for the use of LED UV-A lamps.  This means that the referenced documents section is revised.  There’s also a new section  Section has been modified as well.   Additionally, there has been an editorial change in section 5.2.6.  The committee has included these in the list of corrections at the end of the publication.

Now to get your copy of the new standard.  You can order it in paper format or for pdf download at our Document Center webstore,  Here is a link to the order page for the ASTM E1417/E1417M for your convenience.  It is also available in a redline edition (1 clean copy and 1 marked-up previous edition).  And it can be included in our Standards Online enterprise access cloud service.

For more information, just get in touch with our staff.  We can be reached by phone (650-591-7600) and email (  We have been an authorized ASTM distributor since the 1980’s.  So we’re a great resource when you have questions that other organizations just can’t answer.  That’s why so many companies make us their Standards Experts!

Using the Harmonized List of Standards

Many of you have questions when using the harmonized list of standards for the EU Directives.  Whenever I have a question about any European Harmonized standard, I head to this website:  Here you’ll find all the harmonized lists arranged by subject.

First, what is a harmonized list?  It is a list of all approved standards that can be used to support your product’s compliance with EU legislation.  So if you’re planning on selling your product in Europe, having it meet the requirements of an applicable harmonized standard is one way to support what’s called “the presumption of conformity.”

Browse the homepage for harmonized standards until you find the Directive you’re interested in.  They’ll be listed by their common name, not by the directive number.  Click on the directive and you’ll go directly to its harmonized list page.  You can verify you’ve reached the correct one by checking the directive number in the header material.

The first thing you’ll see is a summary of the documents that comprise the current edition of the directive.  You’ll also get some links to helpful material, like guides for application and EU contacts.  Next is series of links in various languages to the text of the Official Journal publication that officially adopted all the standards in the current listing.  And of course, following this is a 5-column table with a summary of those standards themselves.

Let’s take a look at each column in turn to understand the information in each.  Column 1 is labeled “ESO.”  This is the acronym for European Standards Organization and will tell you which European Standards Body is responsible for the document.  There are 3 choices:  CEN (which is similar to ISO in it’s scope), CENELEC (like IEC), and ETSI (similar to ITU).  CENELEC covers  standards relating to electricity, ETSI to telecommunications, and CEN does everything else.

Column 2 is labeled “Reference and title of the standard (and reference document).”  In this column, you’ll find all the document numbers of standards that have been accepted as harmonized publications by inclusion in the Official Journal.  They are presented as EN numbers, not as any national adoptions.  This means that you are free to choose any of the many country-specific editions you like.  When the standard is an adoption of another publication, like an ISO standard, this is included in parentheses.  Any amending material is also part of the citation if adopted in the Journal.

Column 3 is the “First publication OJ.”  This is the date when the adoption of the standard was first made official by publication in the Official Journal.  Until this happens, an EN standard is not officially considered to be harmonized.

Column 4 is “Reference of superseded standard.”  If this is a first edition of a standard and it does not replace any other standard, the field will be blank.  However, if the document in column 2 is a revision of a previously adopted standard, then you’ll see the previous edition information in this column.  A typical example might be a citation in column 2 of an EN standard plus Amendment 2.  The reference in column 4 would be that same EN standard with the Amendment 1.

And lastly, Column 5 is the confusing “Date of cessation of presumption of conformity of superseded standard.”  Many of you stumble on this date, but with a little explaination it will be clear.  Column 5 is specifically directed to the document in column 4.  The date provided is the last day your product can conform to that superseded edition.  After that day, your products must conform to the document edition specified in column 2.

Using the harmonized lists is an essential part of conforming with European legislation for many products.  Understanding the data the lists provide will make using the harmonized list of standards a rewarding activity.  They can be used to help you implement changes in a timely fashion.  And they can alert you to additional documentation that may be helpful to your organization.

If you still have any questions, please don’t hesitate to get in touch with us.  Our Document Center staff is available to you via phone at 650-591-7600 and email (  We will be able to provide you with a number of options for procuring and using your European standards.  And we can provide you with a variety of tools and services to help you meet your compliance requirements.  Make us your Standards Experts!

ISO 16170

ISO 16170, “In situ test methods for high efficiency filter systems in industrial facilities,” has just been released.  This new 1st Edition provides industries that use high efficiency particulate air filters with ways to do periodic testing.  It’s for filtering systems that are specifically directed to removing toxic or biological materials prior to release of air and other gases into the environment.  Such systems are often used within nuclear and toxic material processing plants and laboratories.

There are already tests used for these types of HEPA and ULPA filtering systems, primarily for quality assurance at the end of the manufacturing process.   However, there has not be an in situ test (done while the filter has been installed and is in service) until the ISO 16170.  You’ll use the tests it provides to confirm that a filtering system in use is performing at the expected level of decontamination factor.

What are the two types of tests included in the ISO 16170?  They are an integrity test and an efficiency accountancy test.  Both types of tests use “test aerosols” that are then measured upstream and downstream of the filters being tested.

What information on these tests is included in the standard?  You’ll get extensive information on prerequisites, test sequences and the evaluation and reporting of the results.  Annex A covers possible choices of aerosols for you to use.  Both Annex B and Annex C are part of the requirements of the standard.  Annex B covers integrity testing, Annex C is for efficiency accountancy testing.  Here’s where you’ll find the methodologies you’ll use for each.  Annex D provides you with information on leakage test methods.  And Annex E is a guideline for representative sampling.  An 11-item bibliography completes this 44 page document.

This new publication provides those of you in industries that handle environmentally problematical materials with a method to periodically test your emissions.  Since inadvertent releases of this type of material into the environment can have such negative impacts, you will want to get a copy and review your current procedures.  The use of a standard like the ISO 16170 can provide you with the documentation you need to make responsible decisions for your facilities.

But where should you get a copy of the ISO 16170?  Use Document Center’s webstore,  We’re an authorized distributor of the ISO standards.  Here’s a direct link to the order page for the ISO 16170.  It is available in paper format or for pdf download.  And enterprise subscription access is also available.

Contact our staff for more information.  You can reach us by phone at 650-591-7600 or by email at  We’ve been working with standards since 1982 and offer you a resource with knowledgeable staff and a wide variety of support services.  When it comes to compliance, make Document Center Inc. your Standards Experts!


ANSI/ASA S1.8 Updated

ANSI/ASA S1.8, “American National Standard Reference Values for Levels Used in Acoustics and Vibrations,” has been updated with the recent release of the 2016 Edition.  The new edition replaces the previous 1989 Edition (reaffirmed in 2011), which is now obsolete.  The reference values in this document “are consistent” with those found in ISO 1683 (“Acoustics – Preferred reference values for acoustical and vibratory levels,” 3rd Edition from 2015).

As you can see, this has been a very stable standard.  It is used to define a quantity of one for various kinds of measurements associated with acoustics and/or vibration.  So you’ll find such information as is included in Table 1:  medium (if applicable — like gas or liquid), variable quantity (let’s use frequency as an example), symbol, and reference value (in this case 1 Hz (Hertz)).  You’ll also find Table 2 which contains the various kinds of levels (sound pressure, frequency, etc.) and the defining equations used for them.

So what could possibly change in a standard like this?  ANSI/ASA S1.8 has actually had a number of technical changes.  They are summarized in the introduction of the new update.  These include the expansion of Table 1, elimination of references to field quantities and the substitution of “reference value” for the previously used “reference quantity.”  Other changes can be found in the incorporation of introductory material from the previous edition into the body of the 2016 publication.  Appendix A has been removed.  And Appendix B is now Annex A.  Even the bibliography has been updated!

So if this is a standard you use, you’ll want to get a copy of this new revision.  Order this and all ASA standards at our Document Center webstore,  We’re an authorized distributor of all ASA standards.  Here is a link to the order page for ANSI/ASA S1.8 for your convenience.

Perhaps you’d like to have cloud access for your team.  Or maybe you have additional questions on this or other standards.  If so, just contact our staff by phone (650-591-7600) or email (  Document Center has been working with compliance information since 1982.  Make us your Standards Experts!

ASTM E1444/E1444M Updated!

ASTM E1444/E1444M, “Standard Practice for Magnetic Particle Testing,” has just been updated.  The new 2016 Edition replaces the previous 2012 Edition which is now obsolete.  And, as noted in my previous posts, the standard is the replacement for the obsolete MIL-STD-1949 (withdrawn in 1993).  It describes a particle testing method used to detect cracks and other dicontinuities on or near the surface of ferromagnetic materials (like iron, nickel and cobalt).

The ASTM E1444/E1444M can be used on materials in a wide variety of states.  It can be raw material, billets, finished material, welds and in-service parts.  It relies on the magnetic properties of ferromagnetic materials as the basis of the test.  You magnetize the area you want to test, apply prepared magnetic particles, and then monitor the resulting particle accumulations for your results.  The standard defines the basic parameters for controlling your application of the particles.  It does not tell you the procedure to use for your specific testing equipment.

While normally an ASTM committee will provide you with a guide to the areas of an update that have been revised, in this new 2016 Edition there is no such paragraph.  So you may want to purchase the redline edition in order to get both a clean copy of the 2016 update and a “marked-up” copy of the previous 2012 Edition showing the exact changes.

You’ll find revisions in the reference standards section, where a new ASTM recommended practice has been added to the list.  Section 5 has changes reflecting use of the new document.  And the quality control section has also been updated with the use of the added practice being referenced in a number of paragraphs.

Now to get your copy of this 22-page standard practice.  Use an authorized distributor like Document Center Inc.  You can search for and order ASTM standards at our webstore,  Here is a direct link to the order page for ASTM E1444/E1444M for your convenience.  And your purchase will come with our best-in-class notification service!

Want to order the redline edition?  Add this standard to a cloud-based enterprise access solution?  Get in touch with our staff by phone (650-591-7600) or email (  They can help you with all your questions and would be happy to get you started with our Standards Online subscription service.  We’ve been working with compliance documentation since 1982.  Make us your Standards Experts!

IEC TR 63039 Risk Analysis for Complex Systems

IEC TR 63036, “Probablistic risk analysis of technological systems – Estimation of final event rate at a given initial state,” has just been released.  It’s a highly technical guide to risk analysis for “electrotechnical items” — that is, systems composed of equipment that use electricity in some way.  So think of this as risk analysis for the Internet of Things, utilities, and so on.

Probablistic risk analysis is a partner to the concept of dependability.  It takes a look at possible negative outcomes and tries to provide guidance on both probability and severity.  IEC TR 63039 provides “a much simpler and realistic approach for probabilistic risk analyses compared to the conventional approaches, and will make it easier to cope with the risks of complex systems.”

So you will find lots of information in this technical report.  It defines both terms and concepts.  It reviews specifying various types of events (things that might happen).  It shows you how to classify event occurances.  It discusses various techniques (ETA, FTA, and Markov) to use, along with how to use various symbols and methods for graphical representation of these.  It suggests ways to both handle and estimate event frequency/rate for complex systems.  And it provides a number of examples to help you understand this process.

As noted, you’ll get a complete discussion of modern risk assessment tools including ETA (Event Tree Analysis), FTA (Fault Tree Analysis) and the Markov technique.  But, as with many technical engineering documents, reviewing concepts is only the beginning.  The report provides you with a wealth of equations to use to in determining such things as quantitative analysis of the occurance of a “final” event, the frequency and rate for repeatable events, and so on.  Many of these permutations of risk are also graphically illustrated by the use of various tables.

Over the last decade or so, the need for better analysis of risk with regards to our systems and infrastructure has become increasingly clear.  The IEC TR 63039 is a significant step forward in providing engineers with the tools necessary to define and rate these types of risk.  Only when we take a look at all possible outcomes for our systems, will we be prepared to handle both routine and extraordinary events.  If this is your field, you need this publication.

And you’ll want to purchase all your standards from a reputable source like Document Center Inc.  We’re a long-time distributor of the IEC standards.  Search for and order them at our webstore,  Here’s a direct link to the order page for IEC TR 63039 for your convenience.  It’s available in either paper format or for pdf download.

If you’d like enterprise-wide access to this or any standard, check in with our staff for more information on our Standards Online service.  You can reach us by phone (650-591-7600) or by email (  Our long experience with standards and the standards process makes us the ideal partner for compliance.  We’re your Standards Experts!