Category: Hot Topics in Standardization

News and Views from the World of Standards

Why are there so many editions of the Standard 60601-1?

Here at Document Center Inc. we often get asked “What’s the difference between a national or regional adoption of an IEC standard and the original standard itself?”  This is a tricky question, since IEC adoptions are not so clear as adoptions of ISO standards at all.

Many national standards are based on IEC documents.   However, these standards may contain national deviations which is why the numbering schema for these adoptions is different than for the ISO standards.  When an ISO standard is adopted, usually the number becomes the acronym for the country (or region), then the original ISO number complete.  For example, the British adoption of ISO 10002 is BS ISO 10002.  However the adoption of an IEC standard is just the jurisdiction acronym and the IEC numeric designation, as in IEC 60950-1 and UL 60950-1.

If you’ve done any traveling outside the U.S., you’ll know the wide array of plug adapters, transformers, etc., that you may require to make your electronic devices and appliances work from country to country.  The fact that the IEC standards are based on electricity (after all, IEC is the International Electrotechnical Commission) is the reason that the standards often cannot be adopted “as is.”

These jurisdiction-specific deviations include the requirements of a country’s electrical code, conflicting national standards for product types or components, and different component requirements, like modified marking requirements.  So a national standards-writing body may decide that the IEC standard can be  adopted only by modifying, deleting, or adding requirements.

Determining the differences between the various adoptions of any given IEC standard can be challenging.  So to help the user out, often the national adoption will specify in the forward or other area of the document what the specific modifications are.

So for our original IEC 60601-1, the many reprints of the standard all represent potential variations from the original material.   Having said that, manufacturers need to design and test their products to the worst-case conditions of the tests that apply to their target markets.

Document Center advises customers to identify all target markets before the design phase is completed and review all IEC standards plus the national adoptions when applicable.  Compliance is a critical issue for our customers and one that our wide range of services supports.

Find the standards you need on our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our expert staff can assist with a wide variety of questions and requirements to assure your organization of compliance in today’s competitive marketplace.

In honor of Giant Matt Cain’s perfect game, we review ASTM Standards on Baseball!

Yes, I’m happy to say I was watching the game last night between the SF Giants and the Houston Astro’s and had the pleasure of watching the Giant’s first perfect game!  Matt Cain, our pitcher, was stellar and both SF offense and defense was there for him every step of the way.  Well, such a performance can’t go unnoticed, so to follow up on the excitement, we review U.S. baseball standards available from Document Center Inc.  And that means that we’re looking at the following ASTM offerings:

ASTM F910, “Standard Specification for Face Guards for Youth Baseball”

ASTM F1881, “Standard Test Method for Measuring Baseball Bat Performance Factor”

ASTM F1887, “Standard Test Method for Measuring the Coefficient of Restitution (COR) of Baseballs and Softballs”

ASTM F1888, “Test Method for Compression-Displacement of Baseballs and Softballs”

ASTM F2000, “Standard Guide for Fences for Baseball and Softball Fields”

ASTM F2107, “Standard Guide for Construction and Maintenance of Skinned Areas on Baseball and Softball Fields”

ASTM F2398, “Standard Test Method for Measuring Moment of Inertia and Center of Percussion of a Baseball or Softball Bat”

ASTM F2844, “Standard Test Method for Displacement Compression of Softball and Baseball Bat Barrels”

ASTM F2845, “Standard Test Method for Measuring the Dynamic Stiffness (DS) and Cylindrical Coefficient of Restitution (CCOR) of Baseballs and Softballs”

If your summer reading plans include catching up on America’s pastime, get over to our website, www.document-center.com, and get one or more of the titles above!  Or just use our service for standards on the other topics in your business life.  You can reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) as well.  We’re here to help you with all your standards requirements.

SAE standards now available in pdf format from Document Center Inc.

Document Center Inc. is proud to announce a new agreement with SAE International (formerly the Society of Automotive Engineers).  This agreement allows Document Center customers to choose the e-delivery option for pdf format copies of all SAE standards.  This includes the AMS, AIR, AS, ARP, MA, MAM, SAE-J and SAE-JA standards.

Customers now can order SAE standards from Document Center Inc. and get a link to download the document within 30 minutes.  The document is protected by the use of the FileOpen DRM (digital rights management) software, so customers need to either have the plug-in already installed with their pdf reader or will follow instructions to download the app.  The document is watermarked and installed on one computer for the use of one person only.  Printing from the pdf file is allowed.

Document Center customers are increasingly requesting e-delivery for the standards we provide.  We are very pleased to be able to add this functionality to such an important document set.  The SAE standards remain one of our most important collections and are frequently requested by our clients.

If you need to download an SAE standard now, order it on our website www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have all current SAE standards available as well as many obsolete editions.  We’re pleased to be your Standards Experts and can assist you with all your standards requirements.

How do Internet sites that sell Standards illegally get customers?

In my investigation of the sites on the Internet that sell downloaded standards illegally, I notice a few characteristics that most sites have in common.  I want to bring these to your attention so that you will not be duped into purchasing a pirated copyright document.

First, it appears that there are only a few individuals that perpetrate the majority of the sites.  We can  determine this because of the use of similar home page designs in various URL’s (Uniform Resource Locator — the website address).

There are about 3 or 4 designs that crop up for several different websites, suggesting that the intellectual property thieves are reusing the code in order to maximize the profits to be made as quickly as possible.  The sites will look like authorized stores, with logos from the actual SDO’s (Standards Developing Organizations) prominently displayed.

Additionally, the home pages display the covers of the standards they offer.  They include copies of standards from API, ASME, AWS, IEC, DIN, SAE, UL, and others.

When you look on WHOIS to determine who owns the website in question, you’ll often find that the owner is located in Florida, unfortunately with a 6 digit zip code that starts with the number 8.  Too bad Florida zip codes are 5 digits and start with the number 3…  Additionally, the names and email addresses of the owners are also patently false or incomplete.  Or the WHOIS information may be linked to a service that provides internet domains anonymously.

These sites are ranking fairly high in website ratings.  They are doing so by posting trackbacks and comments to various blogs.  The blogs they target do not bother to edit the incoming requests.  They tend to not only have trackbacks from these IP (Intellectual Property) pirating sites, but also from sites that offer introductions to young ladies from Russia, storefronts for the purchase of viagra, etc.

The sites in question also use Google adwords to get advertisements posted in the margins when you do a search for a standard.  This is particularly onerous, as it appears to give these sites legitimacy when they are actually in the business of thievery.

We cannot stress enough that should you choose to purchase a document on such a site, you are abetting those who are stealing from the standards community and helping to destroy a system that is already under pressure from the changes in technology we’re currently experiencing.

Stopping these sites is a time-consuming business, costing time and money. Often the cases must be pursued in non-U.S. courts (notably in China).  The results of a favorable judgement are not effective enough to prevent the perpetrators from renewing their services once out of jail.

Since Document Center Inc. is an advocate for proper use of intellectual property and the copyright obligations that accompany the sale of standards, we continue to work with Standards Developing Organizations to identify and solve this problem.

 

ANSI’s response to the OMB Circular A119 petition on Free Internet Access to Standards incorporated into Federal Regulations

Last week I blogged about the petition by a group of academics led by Professor Peter Strauss regarding the availability of standards incorporated by reference in the Code of Federal Regulations (CFR’s).  ANSI, as the umbrella organization for U.S. standards developers, has sent in a reply addressing a number of questions raised by NARA, the National Archives and Records Administration, the executive branch that oversees that part of the CFR addressed by the petition.

The first area of concern for NARA was the meaning of “reasonably available,” existing language in the circular which is at the center of the discussion.  ANSI’s position is that the text of standards and associated documents should be available to all interested parties on a reasonable basis, which includes appropriate compensation as determined by each SDO (Standards Developing Organization).

ANSI brings up the fact that the accessibility of information on the Internet has not diminished the protections of copyright.  They additionally note that online access has not “…changed the need and the ability of standards developers to cover the significant costs of creating the documents that are used to further public policy goals in law and rulemaking.”

ANSI also points out that requiring various agencies to purchase licenses for public access to standards incorporated into regulations would defeat the original intent of Circular A119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.”

The ANSI response notes that if agencies subsidize the costs of certain standards by licensing, then “budgets will need to be substantially increased in order to pay such costs, either through taxes or additional interest on the national debt.”  This is precisely the kind of costs that OMB Circular A119 intended to avoid!

Other areas of concern for NARA, and by extension for ANSI, are articulated in the recent Recommendation issued by the Administrative Conference of the United States.  The ACUS recommendation addresses many of the issues raised by the academic’s petition.

ACUS, an independent agency of the Federal Government, provides suitable arrangements through which the various agencies may cooperatively study mutual problems, exchange information, and develop recommendations for action with regards to regulatory activities and other Federal responsibilities.

The recommendation suggests that agencies should work with the various SDO’s to promote (not mandate) free access to standards referenced in U.S. regulation.  The Conference’s research revealed that some agencies have successfully worked with copyright owners to further the goals of both transparency and public-private collaboration.

For example, some agencies have secured permission to make a read-only copy of incorporated material available in the agency’s public, electronic docket during the pendency of the rulemaking proceeding relating to the material. In other cases, the copyright owner has made the material publicly available in read-only form on its own Web site.  The ACUS recommendation therefore encourages agencies to take steps to promote the availability of incorporated materials within the framework of existing law.

The recommendation has a total of 18 line items to promote effective use of standards within the regulations of the U.S.  Since this encourages increased availability but does not mandate free access, ANSI supports the adoption of the suggestions by NARA.

Document Center Inc. congratulates ANSI on an articulate and timely response to NARA’s request for comment.   This is a subject that concerns both Standards Developers and Intellectual Property owners in general.  Use of copyright material, patents, and so on in public documents requires a fine balancing act between the needs of society and the rights of the property owner.

The petition reminds us that the perception of access to standards and other copyright material can be improved.  Document Center actively promotes new ways for the public to find and purchase the standards they need.  Hopefully the suggestions of ACUS will encourage Federal Agencies and SDO’s to continue to work together to come up with innovative solutions to this complex problem as well.

Proposed changes to OMB Circular A-119 could impact the Standards Community

On February 27th of this year, a Federal Register notice called for comment on a petition filed by a group of academics.  This petition would amend the OMB Circular A-119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.”

The Circular has been instrumental in directing Federal regulators, including the Department of Defense specifications and standards program, to move from government developed and maintained standards to the adoption of industry standards.  It has had a huge impact on the entire process of developing and implementing standards for both industry and government.

The usual process for government adoption of standards for regulatory processes is for industry standard in question to be called out by number, including date, in the applicable volume of the Code of Federal Regulations (CFR’s).  There are over 9,000 such references in federal regulations at this time.

In the main, these industry documents must be purchased by those needing to comply with the law.  This allows the  standards organization that develop, monitor, and revise the standards to fund the costs associated with this caretaking activity.

Indeed, the original impetus for the Circular in the first place was to reduce government expense by avoiding duplicate activity within both the private and public sector.  It was intended to pave the way for more government participation in industry standards-making processes, including the costs involved in such participation.  However, it must be remembered that those costs are not only borne by those who develop the standards, but also by those who use them through the vehicle of the purchase price.  Further, industry standards are normally copyright material, with the full protection afforded by that coverage.

The petition by the academics seeks to make standards that are referenced in the CFR’s available on the Internet at no charge.  “Today, binding law cannot be regarded as ‘reasonably available’  if it cannot freely be found in or through an agency’s electronic library.”  The petition goes on to suggest that perhaps this could be provided through a licensing agreement between the agencies involved and the standards associations themselves.

Of course, there is the further question of how such free, public availability of certain standards would impact revenue from sales that are not related to the use of the regulation itself.  My own use of search engines to find specific standards has lead me to find approximately a half-dozen illegal sites involved in the unauthorized sale of copyright material.  This suggests that  the public is still interested in inexpensive or free standards without regards to the economic impact of such transactions.

As one would expect, the standards community in the U.S. is very interested in the results such a change would have on the entire standards process.  ANSI is accepting a leadership role in voicing the concerns of Standards Developing Organizations (SDO’s) to the issues raised by the petition.

Document Center Inc. monitors such activity on a regular basis and is also concerned about how this petition would change the financial structure for SDO’s.  We’ll cover the ANSI response to the call for comments in a blog next week.  Meantime, if you have comments, please let us know.

Standards Publishers plagued by “intellectual property piracy Internet sites”

For the second time in the last two months, I’ve run across sites put up by intellectual property pirates.  These sites harm the international standards community in any number of ways, and I’m going to count them out for you!

1.  The unauthorized sale of standards without compensation to the copyright holder ends up making the cost of standardization rise for the rest of us.

If there’s one thing that standards users hate, it’s the rising costs of standards documents.  However, the price you pay for standards pays for the work that goes into developing that standard, and it ain’t cheap.

Standards are the product of many months, even years, of effort by technical experts and other interested parties, administrated by professional not-for-profit organizations.  The work is published and maintained by these folks in our best interests, making the products and services we use safe, interoperable, and innovative.

2. When the cost of standards rise, the costs of the goods we buy also goes up.  Having standards distributed without paying for the development and distribution of those same standards negatively affects our economy.

3.  You have no way of knowing if the document you purchase is the latest edition.  You will not be notified when the technical content of the standard changes.  There is no service here.  This interaction aims to take your money and run.

4.  You negatively impact the way that standards organizations monitor the usefulness of the documents they publish.

Standards organizations want to make sure that the standards they develop and maintain are worthwhile.  They keep statistics on what standards are getting lots of use as well as considering the necessity of a standard for public well-being.   This information helps to focus standards resources on those areas that will benefit us all the most.

When standards are promulgated illegally, the picture we have of the impact of standards on commerce and public safety is skewed.

5.  There is a cost to Standards Developing Organizations to shut down these sites.  As if the cost in lost revenue wasn’t enough…

How do you spot a site that is selling pirated copies of standards?

It’s easy.  The prices are too good to be true.

The first site I spotted had standards selling for $19.00 and up.  The second was similar, with the true prices X’ed out and substantially lower prices offered as the sale price.

Another thing to consider: If you’re going to purchase from a site that is stealing the goods they offer you, there’s no guarantee that they won’t also steal your information at the point of purchase.  After all, if these guys are willing to steal from ANSI, ASME, ASTM, ISO and the rest, why wouldn’t they steal from you?

I can’t stress enough the benefits of purchasing your standards from legitimate distributors like Document Center Inc.  We handle all our sales either under contract or like a bookstore, purchasing our stock for resale.  You’ll get superior service, both at the point of sale and afterwards, with confidence that the information you give us during the business transaction is not being exploited.

We’ve been in business since 1982 and under contract with our publisher partners since the 1980’s.  You can put your trust in us to keep your standards collection current, while knowing that both the funds and sales records are correctly being channeled to the intellectual property owners as well.

Popular ASTM Standards on Consumer, Pharmaceutical and Medical Packaging

ASTM International produces standards on a wide range of topics.  With a history of specializing in testing and material standards, the organization issues short, concise, and focused documents used the world over.  They are among the most frequently ordered standards we sell.  In today’s blog, we’ll list those ASTM standards for consumer, pharmaceutical and medical Packaging.

  • ASTM D2063 / D2063M, Standard Test Methods for Measurement of Torque Retention for Packages with Continuous Thread Closures Using Non-Automated (Manual) Torque Testing Equipment
  • ASTM D3198, Standard Test Method for Application and Removal Torque of Threaded or Lug-Style Closures
  • ASTM D3469, Standard Test Methods for Measurement of Vertical Downward Forces to Disengage Type IIA Lug-Style Child-Resistant Closures
  • ASTM D3470, Standard Test Method for Measurement of Removal Lug Strippage of Type IIA Child-Resistant Closures
  • ASTM D3472, Standard Test Method for Reverse-Ratchet Torque of Type IA Child-Resistant Closures
  • ASTM D3474, Standard Practice for Calibration and Use of Torque Meters Used in Packaging Applications
  • ASTM D3475, Standard Classification of Child-Resistant Packages
  • ASTM D3481, Standard Test Method for Manual Shelling Two-Piece Child-Resistant Closures That Are Activated by Two Simultaneous Dissimilar Motions
  • ASTM D3810, Standard Test Method for Minimum Application Torque of Type IA Child-Resistant Closures
  • ASTM D3968, Standard Test Method for Monitoring of Rotational Torque of Type IIIA Child-Resistant Closure
  • ASTM D4267, Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
  • ASTM D4774, Standard Specification for User Applied Drug Labels in Anesthesiology
  • ASTM D4775, Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
  • ASTM D5022, Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use
  • ASTM D5094 / D5094M, Standard Test Methods for Gross Leakage of Liquids from Containers with Threaded or Lug-Style Closure
  • ASTM D6398, Standard Practice to Enhance Identification of Drug Names on Labels
  • ASTM D7257, Standard Test Method for Automated Shelling Two-Piece Child-Resistant Closures That Are Activated by Two Simultaneous Dissimilar Motions
  • ASTM D7298, Standard Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
  • ASTM D7709, Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

Document Center Inc. has been an authorized reseller of ASTM standards since the 1980’s.  Use our website, www.document-center.com, to order online or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have an extensive collection of obsolete standards, as well as all current editions.

New Italian Standard on Guidelines for festivities celebration spreads Holiday Cheer

In the face of economic uncertainty and questions about the fate of European solidarity, the Italians have released Standard CEI 25.12.2011, “Guidelines for festivities celebration,” to give us a smile and spread a little holiday cheer!

Created to mimic the usual format of legitimate standards, the Guideline has all the usual sections.  For example, here is a translation of the scope paragraph:

In mid-2002, the Ministry of Attention (MDA) and the Ministry of
Tradition and Folklore (MDTF) expressed a desire for standardization of the rituals that accompany the event which has taken place on December 25th for many centuries now.  Although over time there has been a lot of literature on the subject, the ministries concerned have felt the need to publish a standard for a safe and quality-focused celebration.  This document was  thus developed in the context of the recent Directive on Standards and Values ​​and in the light of the disappearance of the same standards and values, as well as to promote the nature of the tradition of the historical and educational Santa Claus.

Please be sure to look at the entire standard, as it contains many cogent points and supportive illustrations.  And use Google translate to help you out as well!  The text has been very well thought out.

Our hats off to the committee that has brought us such a timely and valuable document!

There are actually few spoof standards available for review.  The only other one I’ve ever come across is ASA K100.1, “American National Standard Safety Code and Requirements for Dry Martinis.”   The ASA Sectional Committee on Liquids Management, 16-1, hoped the standard would be well received by all elements of the industry and that when the committee sobered up it would be in condition to consider further developments in the state of the art.  I’m unsure of the outcome, as the standard was generated in 1966 and has remained stable ever since!

These standards lend a bit of fun and lightness to an area of business that is often very competitive and serious, proving that engineers have a sense of humor too.

Buon Natale!  And best wishes for the New Year from us all at Document Center Inc.!

New ASTM D1003 2011(e1) Edition has Editorial Changes for Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics

ASTM D1003:2011(e1) Edition, “Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics,” has just been released.  The new revision contains editorial changes only and does not impact the technical content of the 2011 Edition.

This test method covers the evaluation of specific light-transmitting and wide-angle-light-scattering properties of planar sections of materials such as essentially transparent plastic. Two procedures are provided for the measurement of luminous transmittance and haze. Procedure A uses a hazemeter (described in Section 5) and Procedure B uses a spectrophotometer (Section 8). Material having a haze value greater than 30 % is considered diffusing and should be tested using Practice ASTM E2387, “Standard Practice for Goniometric Optical Scatter Measurements.”

The concept of the (e1) Editions is confusing at first, but when explained is easy to understand.  It is an unusual designation but used with some regularity by ASTM International.  It means that the standard has been modified in a way that does not affect the technical content of the document.

So in the case of ASTM D1003, the new 2011(e1) edition re-formats the 2011 edition by consolidating the 4 tables onto one page instead of two.  This re-positioning of the tables makes them easier to find and use, but does not affect the standard itself.

Editorial changes can be changes to addresses or phone numbers referenced in the footnotes, or other similar small corrections to non-technical matters.  So the big question is, when an editorial correction is released, should you purchase it or not?

We suggest the following to our customers.  If you are regularly audited and need to have your documentation confirmed current, you should purchase the corrected edition.  It’s just not worth the cost of the corrected edition to risk being written up during an audit.  If you are interested in using the document for the sake of the content only, it is probably OK to wait for the next revision level.  And the same advice holds true for reaffirmed editions as well.

All ASTM current standards and many of the obsolete revisions are available from Document Center Inc. via our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with all your standards questions and requirements.