New ISO/TR 37150 – Metrics for Smart Community Infrastructure

April 4th, 2014

ANSI held it’s Spring 2014 Company Member Council (CMC) meeting in San Diego this year, with Qualcomm hosting.  I attended and found the meeting to be very informative.  One of the four major topics was interoperability, and the concepts of “smartness” and “infrastructure” were referred to frequently.  Since community infrastructure is a priority at the International level, standards activities are supporting that effort.  And the release of the new ISO/TR 37150, “Smart community infrastructures – Review of existing activities relevant to metrics,” provides background information to support relevant standards development.

The idea behind “Smart” (whether it’s the Smart Grid, Smart Cars, Smart Homes, etc.) is the implementation of computer-aided communication (interoperability) to provide remote access, monitoring, and diagnostics via the “Internet of Things” (IOT).  The impact that this transformation of our infrastructure will have is affecting business and standards across many sectors.  For example, with community infrastructure discussed in the ISO 37150, primary areas of focus are energy, transportation, water, waste, and ICT (Information and Communications Technology).

In order to get a handle on existing information and projects in process, the committee collected and reviewed material on Standards and Frameworks already in existence and on various projects currently underway around the world.  These documents and projects were defined in part by using the Millennium Development Goals (MDGs).  These goals were referenced a number of times in the ANSI presentations on Interoperability as well.

The process by which all the information was collected included a questionnaire, with results published in Annex B.  Literature and internet surveys rounded out the effort.  This included both searches for documents and for projects, and was broadly based to avoid excluding specific regions or different concepts of smartness or interoperability.  You’ll find a list of the identified activities in Annex A with a detailed review of the results presented in Annex D.

The committee wraps up the document with a discussion of future directions.  First is a review of attributes that would provide a positive set of smart community infrastructure metrics in general.  Other aspects of the concept are also discussed — their thinking on metrics, community, smart and infrastructure are all addressed.  Then the committee provides you with a gap analysis, to suggest areas where further standardization efforts may be required.  Other possible related areas that should be investigated are also presented.

As a wide variety of industries recognize the inherent convergence of technologies surrounding the potential of the IOT, standardization is following suit.  These initial reports like the ISO/TR 37150 provide the groundwork for what will surely be an ambitious standardization work program in the future.

To purchase this ISO Technical Report or any of the ISO standards, please visit our Document Center webstore at www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

Make us your Standards Experts!

New BS 10501 helps you prevent procurement fraud!

April 3rd, 2014

When it comes to internal problems in the business world, there are two types of fraud that can be very difficult to detect – accounting fraud and procurement fraud.  In both cases, trusted employees can devastate a business, leaving a trail of financial difficulties and disillusionment.  So we’re particularly pleased to announce that the British Standards Institute has just released a new standard on one of these topics!  BS 10501, “Guide to implementing procurement fraud controls,” can help the management of every organization review and improve the controls that minimize the risks associated with this type of fraud.

This new standard is definitely part of the risk management profile standards that have been released in a wide variety of sectors lately.  Specifically geared towards improvement of the purchasing function, it has guidance in a number of essential areas for concern.

Like all areas of risk, the first step is the identification of the risk itself.  Once identified, the user of the standard will then get specific information on how to mitigate this risk.  In addition, guidance is offered on how to actively manage related challenges in the business process.  The standard covers how to detect, report and respond to potential fraud, and how to implement and monitor controls to minimize opportunities.

No matter the size or the mission of your organization, fraud of this nature is a real threat to the integrity of your group.  Your company must be aware of the types of fraud that exist and what controls minimize the potential for each.  You need to remember that reducing temptation and the potential for fraud is in everyone’s interest.  And you need to remember that this type of criminal activity is often the least reported and least litigated type of loss for a company.

With all the challenges every organization faces, reduction of risk when possible only makes good business sense.  You’ll find BS 10501 to be a great starting point to tightening up your purchasing process to make it more effective and less likely to be abused.

You can get your copy from the Document Center webstore at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be pleased to be working with experts who can help you identify and maintain those standards essential to your compliance efforts.  And you’ll be amazed at the wide range of products and reports we offer to support that effort.  Make us your Standards Experts!

New ISO/IEC Guide 51 for the inclusion of safety in standards

April 2nd, 2014

The new 3rd Edition for ISO/IEC Guide 51, “Safety aspects – Guidelines for their inclusion in standards,” was developed for the technical committees of ISO and IEC.  But there’s no organization that develops standards (including internal standards, industry standards and governmental standards) that should not consider the tenets of this new Guide.

Engineers sometimes tackle problems in a way that may not actually meet customers’ expectations of safety.  It is important to remember that risks arise not only from the proper use of your product or process, but also from unintended uses too.  The ISO/IEC Guide 51 provides a structure for helping folks in your organization get a real-world understanding of safety and how to build it into your definition documents.

The term “safety” in this standard is actually quite broad.  It includes aspects related to people, property, and the environment.  And the consideration of safety is to be extended to the entire life-cycle of the product or system.  This would include design, production, distribution, use (including maintenance), and disposal.   Not only that, but the standard requires that not only intended use but also reasonably foreseeable misuse be considered as an aspect of safety as well.

The first issue addressed in the document is a discussion of safety vs. risk.  (I hear a sigh of relief from all you engineers out there!)  Since the perception of safety is actually the reduction of risks from hazardous situations, the guide reviews the elements of risk.  It then reviews a methodology for achieving tolerable risk.  You’ll be pleased to note that there are ample flowcharts in this area that can assist in educating your product and standards developers in the concepts of risk.

Next the Guide 51 reviews how various types of standards rely on safety concepts in varying degrees.  For example, safety standards may be for safety in general, for a group of products or systems, or for a specific item.  And standards that don’t deal directly with safety may include aspects of safety as a part of the document, including the use of safety standards in the referenced documents section of the publication.

Lastly, the ISO/IEC Guide 51 reviews standards development, showing where safety concerns should be introduced into the process itself.  You’ll find guidance on the topic during the proposal phase, drafting, and even during the development of warnings, instructions, and so on.  Another useful feature of the 22 page update is the bibliography, which has 34 references for further review.

If you’ve already been using this guide, you’ll want to know where the changes are in the new 3rd Edition.  You’ll find that the primary changes from the 2nd edition are as follows:

  • The concept of risk reduction is strengthened, and Figure 2 has been revised.
  • “Harmful event” is now “hazardous event.”
  • Terms relating to consumer safety have been updated.
  • Figure 3 has been revised, with more detail of risk reduction steps.
  • The Introduction provides more background information.
  • The concept of vulnerable consumers is expanded.
  • Referenced documents and the bibliography are revised.
  • Clauses 6 and 7 have been reorganized and consolidated.

Safety considerations should be at the top of the list for every standards developer.  Certainly, adherence to this new Guide will be mandatory for the committees of ISO and IEC.  If you’re responsible for the standardization within your organization, you’ll want to review this new Edition too.

You’ll get your copy from Document Center, either in paper format or for pdf download.  Just go to our webstore at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing ISO and IEC standards under license agreement since the 1990′s.  Our responsive and knowledgeable staff are the reason customers keep coming back.  Make us your Standards Experts too!

New AAMI TIR50 released for Use Error Detection

April 1st, 2014

With Medical Devices, minimizing risk for users and improving product safety and usability is paramount.  The new AAMI TIR50, “Post-market surveillance of use error management,” is geared to help anyone involved in the MedDev space learn how to best collect, review and act on post-market use error data to improve their products or processes.  It helps the reader develop a process for handling complaints based on usage errors of any kind.  Since these types of problems aren’t necessarily covered by regulatory requirements, this presents an opportunity for companies to improve customer satisfaction both short and long term.

What caused the interest in producing such a standard?  The FDA gets about 100,000 Medical Device Reports (MDR) annually.  Of those, one-third mention “error” in the filing.  Currently, there’s no clear data on what exactly all those “errors” are.  They may be user error of course.  But they might also stem from inadequate instructions or unclear markings on the devices themselves.  And AAMI was also concerned that there may be under-reporting issues due to the natural tendency to avoid a situation in which the party doing the reporting might risk being blamed in “near-miss” situations.

The Technical Information Report 50 guides you, the user, in developing a protocol and system for capturing use errors.  It describes process flow, training and scalability for your data capture and analysis efforts, including sample questions you might include in your database.

Interestingly enough, the Report approaches this issue from two distinct viewpoints — that of the manufacturer and that of the user.  This means that a clinician can find this document has helpful as a medical device manufacturer.  Why would the authors want to include both audiences?  Certainly both groups have a vested interested in assuring the proper use of medical devices, and in improving both processes and products to facilitate that goal.  So Section 7 of the document provides process recommendations for manufacturers while Section 8 covers the topic from the clinical perspective.

The document has 2 Annexes as well.  One covers suggested questions as I noted above.  The other has information that will help a manufacturer link customer complaints to usage errors.  This is intended to be part of your Usability Engineering effort, perhaps when designing a second generation product, or to forecast potential issues when designing a new product.  The Report is completed by a bibliography containing 19 citations to provide further reading on this topic.

Of course, you’ll need to get a copy of the new TIR50.  You can go to Document Center’s webstore, www.document-center.com, and order it in either paper format or for pdf download.  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  AAMI is an important contributor to the medical device standardization effort and Document Center is proud to be an authorized distributor of the AAMI publications.

New ASTM E18 2014 Edition released – Rockwell Hardness

March 31st, 2014

The popular ASTM E18, “Standard Test Methods for Rockwell Hardness of Metallic Materials,” has just been updated.  The new 2014 Edition is available from Document Center Inc. in either paper format or for pdf download.  The 38-page standard covers both the Rockwell Hardness and the Rockwell Superficial Hardness tests.  It includes both the requirements for the testing machines and the procedures for the tests themselves.

This new ASTM E18 2014 Edition cancels and replaces the previous 2012 Edition (I blogged on that edition when it was released.)  There are 10 notable changes to this update.  They are all contained in the Annex A3, Standardization of Rockwell Indenters (one of the mandatory Annexes):

  1. Section A3.4.5.1 was revised,
  2. Section 3.4.5.4 was revised,
  3. Section A3.5.3.2 was revised,
  4. Section A3.5.3.7 was revised,
  5. Section A3.8.2 was added,
  6. Section A3.8.3 was added,
  7. Section A3.9.1.6 was added,
  8. Section A3.9.3.6 was added,
  9. Table A3.4 was added, and
  10. Table A3.7 was added.

FYI: Section A3.4 covers ball identers, Section A3.5 covers Class B diamond indenters, Section A3.8 covers marking and Section A3.9 covers the certificate.  The new Table A3.4 addresses test blocks used for singular or limited scale ball indenter performance verification, plus maximum tolerances, for standardized reference blocks.  And the new Table A3.7 covers the same thing for Class A or reference indenter.

To get the complete details of all the updates to this new revision, purchase the redline edition.  You’ll get a copy of the new 2014 Edition plus a copy of the previous 2012 Edition with the changes all included and highlighted.  Ask about this when you place your order.

You’ll purchase your copy using our Document Center webstore, at www.document-center.com.  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing our customers with ASTM standards under license agreement since the 1980′s.  We’ll be able to assist you with any questions you may have about these documents.  And we’ll track them for you so you don’t have to worry about becoming non-compliant.  Make us your Standards Experts!

New BS EN 16309 supports sustainable construction in Europe

March 28th, 2014

Europe has been addressing many areas of it’s infrastructure in recent years, with regulation promoting green goals of reduction of hazardous materials, improved sustainability of products, and life-cycle requirements for goods sold there.  So it is no surprise that in 2011 the requirements for building materials and construction works were updated.  The new BS EN 16309, “Sustainability of construction works. Assessment of social performance of buildings. Calculation methodology,” is part of that effort.  It provides the specific methods and requirements for the assessment of the social performance of a building.  This covers the specific areas of accessibility, adaptability, health and comfort, impacts on the neighborhood, maintenance, and safety and security.

The standard is part of a series of documents on integrated building performance.  The areas that are being addressed by this series are environmental, social, economic, technical, and functional performance of buildings.  For each of these concept levels, there’s corresponding documentation to cover the framework level, building level and product level.

The environmental area has been completely “built out.”  And the BS EN 15643-1, BS EN 15643-2, BS EN 15643-3, and BS EN 15643-4 cover the framework level for environmental, social and economic categories.  So the BS EN 16309 is the assessment document that addresses social performance at the building level.

It applies to all types of buildings, both new and existing.  The standard gives requirements for:

  • the description of the object of assessment,
  • the system boundary that applies at the building level,
  • the list of indicators and procedures for the application of these indicators,
  • the presentation of the results in reporting and communication,
  • the data necessary for the application of the standard, and
  • verification.

It does not specify any particular valuation method.  You’ll be determining your own benchmarks or assessment goals based on national requirements, other regulatory codes and so on.  You’ll also note that corporate social responsibility issues are not addressed in this standard.  And the issues of sourcing of materials and services and stakeholder involvement that are included in the parent document BS EN 15643-3 have been left for a future revision.

If you need a copy of this new BS EN 16309 or any European standard, head to the Document Center webstore at www.document-center.com.  Or you’re welcome to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards since 1982, so we can assist you with all your documentation requirements.  Make us your Standards Experts!

New ISO 8600-4 2nd Edition for Endoscopes

March 27th, 2014

The ISO 8600-4, “Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion,” has just been revised.  The new 2nd Edition is available from Document Center in either paper format or for pdf download.  The document is one of 7 parts that comprise the ISO 8600 series on Endoscopes.  It updates the 1st Edition which was released in 1997 (and is now obsolete).

The endoscope is an essential tool in the medical device arsenal.  Simply defined, it’s a medical instrument for viewing that is inserted into a natural or surgically created body opening.  Used for examination, diagnosis or therapy itself, these devices usually consist of a rigid or flexible tube, a light source, a lens or video system to see or capture the image from the inserted end of the scope, and an additional channel to deliver medical instruments or manipulators.

It’s the Part 4 of the series that has just been updated, on the maximum width of the insertion portion of the endoscope.   The changes to the 8 page document involve combining the old sections 2 and 3 into a new section 2 on test conditions.  This means that the new edition is now laid out as follows:

  1. Scope
  2. Test conditions (includes test environments and the accuracy of measuring instruments)
  3. Methods of measurement (includes general overview, millimeter indication, and french size indication).

Figures 1 and 2 are still included.

Here’s a complete list of the standards in the series, as well as their issue dates so you can confirm you’ve got the latest editions:

  • ISO 8600-1, 2013 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements
  • ISO 8600-2, 2002 Edition, Optics and Optical Instruments – Medical Endoscopes and Endoscopic Accessories – Part 2: Particular Requirements for Rigid Bronchoscopes
  • ISO 8600-3, 1997 Edition with Amendment 1 from 2003, Optics and Optical Instruments — Medical Endoscopes and Endoscopic Accessories — Part 3: Determination of Field of View and Direction of View of Endoscopes With Optics
  • ISO 8600-4, 2014 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion
  • ISO 8600-5, 2005 Edition, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 5: Determination of Optical Resolution of Rigid Endoscopes With Optics
  • ISO 8600-6, 2005 Edition, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 6: Vocabulary
  • ISO 8600-7, 2012 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 7: Basic requirements for medical endoscopes of water-resistant type

Of course, if you need the any of the ISO 8600 series, you’ll want to purchase your copy from Document Center Inc.  You can do this at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  It’s essential that you discover those standards that could impact your business, and maintain those that you reference in your documentation.  That’s why we have a wide range of products and services to help you with this task.  We help many companies around the world with their standardization requirements.  Make us your Standards Experts!

New FDA Guidance for CLIA Categorization

March 26th, 2014

The FDA has just released a new guidance document, “Administrative Procedures for CLIA Categorization – Guidance for Industry and Food and Drug Administration Staff.”  It describes the classification system for clinical laboratories that accept tissues taken from people for diagnosis or treatment of disease.  It is geared for organizations that rely on those laboratories for FDA regulatory compliance, particularly for IVDs (in vitro devices).  This FDA Guidance for CLIA Categorization updates information on FDA administrative processes for the CLIA process, including the e-copy program which is voluntary for this situation.

CLIA testing is divided into 3 levels:  waived tests, moderately complex tests, and highly complex tests.  The FDA catagorizes the tests for a particular device when it is submitted for 501(k) or premarket approval.  At this point it is assigned a CLIA Record number (CR).  The particular level of complexity assigned by the FDA then means that any testing lab used must be cleared for tests at that level.

This guidance covers the process of assigning the CR number.  It also reviews what to do if your product does not need 501(k) or premarket approval, but is still covered by the CLIA requirements.  You’ll get a CR number too, and the protocol is included in this guidance.  It also has a section on the issue of waiver protocols and applications.

While the FDA guidance documents are not enforceable, they provide industry will a clearer understanding of the processes of FDA regulators.  And they can also clarify how the FDA views certain topics or issues that may affect your products.  If CLIA affects your business, you may also want to review the “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” from 2008.

The move to using electronic submissions for these types of activities has been prompted by the paperwork reduction act.  As the FDA discovers the benefits to staff in using online protocols and the benefits gained from the automatic database generation inherent in these systems, more processes are being moved online.

You can get the compliance information you need for FDA and other certification systems from Document Center Inc.  Try using our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been providing companies like yours with technical information since 1982.  Make us your Standards Experts!

New MIL-PRF-50884 Rev F replaces MIL-P-50884

March 25th, 2014

When it comes to the requirements for printed wiring boards for U.S. military usage, the MIL-PRF-50884 is an essential specification.  And the new Revision F, “Printed Wiring Board, Flexible or Rigid-Flex, General Specification for,” has just been released.  Previously numbered MIL-P-50884, the change in designation means the document is now classified as a performance specification.  The requirements are couched in terms of how the boards will perform, not on a detailed definition of how to produce them.

This spec was frequently referenced until it became inactive for new design in 1999.   The new revision remains inactive for new design — It is used exclusively for replacement purposes.  (Refer to MIL-PRF-31032 for new design.)  This new Revision F is a 136-page document, replacing MIL-P-50884 Revision E with Amendment 3 and all previous editions of that publication.  However, the good news is that it is not necessary to change any existing drawings that reference the older editions.

MIL-PRF-50884 is used for printed wiring boards, divided into 5 types as defined in IPC 2223 (replacing the obsolete MIL-STD-2118).   These boards are either Use A or Use B, supporting flexing either in installation or in use.  And they’ll be designated either grade R or grade U for rework.

The bulk of the document is actually the 8 Appendices (A through H.)  They cover:

  • Product assurance (performance and verification) requirements for QPL level
  • Product assurance requirements for QML level
  • C=0 sampling, test equipment and suitability of inspection facilities
  • Supersession and usage of current and legacy design standards
  • Qualification requirements for all levels of product assurance
  • External visual and dimensional illustrations
  • Metallographic illustrations
  • Quality conformance test circuitry.

Compliance with the new document is effective as of 9/15/2014.  This means that for contracts going forward, meeting the requirements of the new Revision F will be necessary.  In fact, if your product contains such printed boards as a component part, you’ll need to be assured that the boards you use meet these new requirements for any contracts you are awarded as well.

Changes are extensive, so they are not marked in the margins as is sometimes the case.

You’re able to get your copy of this new update from Document Center’s website at www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards since 1982, with much of our business supporting government contract work.  We have the documents and tools you need to procure and maintain your collection of compliance documentation.  Make us your Standards Experts!

New MIL-STD-883 Includes Revision J with Changes 1 and 2

March 24th, 2014

A new edition of the popular MIL-STD-883, “Microcircuits,” has been released and is available now from Document Center in either paper format or for pdf download.  The 759 page update includes Revision J plus Change Notices 1 and 2.  The new changes to the Test Method Standard are effective immediately, which means you need the new copy right away if you need to meet it’s requirements for any contracts you have.

I’ve blogged about the MIL-STD-883 before, since it is one of the most frequently ordered mil standards we sell.  So please review my blog on the new MIL-STD-883 Revision J and my blog on the new MIL-STD-883J with Change Notice 1 for more information on previous updates.

The change in this new release is minimal:  Method 2010 is changed.  Now in the test method “INTERNAL VISUAL (MONOLITHIC),” Section 3.1.1.1 for Metallization scratches, Paragraph h for Scratch (Probe Mark(s), etc.) the “or” has been changed to “and”, which means it requires a dual criteria for failure.

Back in the olden days, just a two page change notice would have been released.  The cover sheet would have summarized the changes, while a second page would have been available, either for pen-and-ink changes or as a reprint of the changed page itself meant to replace the original page.  (If you worked with Mil Standards back then, I’m sure you remember removing and replacing pages in various documents with some regularity.)

Now that the Mil Specs and Standards are all maintained as electronic documents, changes are issued as a complete corrected republication of the document.  Yes, this standard is 759 pages.  And the change on 1 page has resulted in the reissuing of the entire MIL-STD-883!

As long as we’re reviewing this MIL Standard, I also would like to mention the numbering system of the various test methods that are included in the document.  When you get the standard, you’ll notice that Test Method 2010 is now labelled “Method 2010.14″ and dated March 14, 2014.  In the previous edition (Revision J with Change Notice 1), the test method was labelled “Method 2010.13″ and dated June 7, 2013.  The Method 2010 is the number of the test method (in this case, INTERNAL VISUAL (MONOLITHIC)) and the .14 is the release number.

The other thing to remember about these test method standards is that each test method is numbered separately.  So the 1st page of test method 2010 is page 1, not 233 which is the actual page if calculated numerically with page 1 being the cover sheet.

If you need the latest edition of MIL-STD-883, you can use the Document Center webstore at www.document-center.com.  Or you can contact our sales staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll use us to purchase your mil specs and standards so you’ll be informed when changes to your documents are issued.  Face it,  there’s no other resource you can turn to for consistent information on changes like Document Center Inc.  The combination of our website features, our blogs and our notification and reporting services make it easy to use and maintain your conformance standards collections.  Make us your Standards Experts!