ASTM D412 updated – Tension testing

ASTM D412, “Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers – Tension,” has just been revised — twice!  The ASTM D412 2015 Edition and the ASTM D412 2015a Edition were both approved in December and published in January.  Yes, this does cause confusion but hopefully we can discuss the publications and make your next purchase a little clearer.

ASTM D412 is a widely used test method standard for tension testing.  It’s remained stable since 2006 with the exception of a couple of editorial changes.  So we know that the new 2015a Edition does contain technical updates that you’ll need to use going forward.

However, the technical committee in charge of the standard has not provided any guidance as to what those changes are.  So your best bet is to get the redline edition which includes a copy of the previous 2006a Edition (reaffirmed in 2013) with the changes clearly marked and a clean copy of the new 2015a Edition.  FYI:  There is no redline edition available for the briefly valid 2015 Edition.  So we must assume that there was an issue that was identified and resolved very quickly after the first approval.  However, that approval did result in the 2015 Edition getting pushed through the publication cycle.

Why do folks use the ASTM D412?  It contains the test methods you’ll use to evaluate the tension properties of various thermoset rubbers and thermoplastic elastomers.  Included are both the “dumbbell and straight section” test method A and the “cut ring” test method B.  This refers to the types of specimens that are used in each test.  Also to be noted is the fact that the standard not only provides you with detailed information on the tests, but like many of the ASTM publications of this type, it also provides you with reporting requirements.

How can I get a copy of ASTM D412?  ASTM D412 is a copyright standard and needs to be purchased from an authorized dealer like Document Center Inc.  The publication is available in paper format, for single-user pdf download, as a redline edition, and as part of our multi-user subscription access product, Standards Online.  Order on our webstore, www.document-center.com.  Here’s a direct link to the order page for ASTM D412.  Need help?  Just contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with ASTM since the 1980’s.  Make us your Standards Experts!

ISO/IEC 30130 released – Software Testing Tools

ISO/IEC 30130, “Software engineering – Capabilities of software testing tools,” has just been released by JTC1, the joint technical committee of ISO and IEC.  This new standard defines the framework that you’ll use when evaluating software testing tools for specific projects.  Since the use of these products makes the job of validation and quality testing much more efficient and effective, using the right one for your purposes is essential.

The standard was developed to address the issues that are cropping up now that software programs can be so complex and large in size.  Software testing tools for such programs vary widely based on the context in which they will be used.  As new tools are released, it’s become more difficult to understand exactly what various tools can do and compare and contrast various products.  So ISO/IEC 30130 shows you how such tools are developed using existing standards, what the inputs and outputs should be, and the criteria to use to evaluate any given testing program.  And the good news is that not only can this process be used for evaluation, it also will provide you with a framework for training, etc.

What’s actually in ISO/IEC 30130?  The standard starts with the usual scope, referenced documents and definitions clauses.  Clause 4 is an overview of the object model used for software testing tools.  Clause 5 reviews the various categories for these products.  Next comes sections on characteristics and capabilities of software testing tools.  Here you’ll find such things as quality characteristics and granularity, dynamic test execution, code analysis, and test management.  Finally, the standard has an Annex A with tables showing you capabilities mapped to test processes and an Annex B which reviews the approach used in developing this standard.  A 7-item bibliography completes the document.

FYI:  Annex A tables are particularly useful, since they show you how to map the capabilities of a given tool to the processes of ISO/IEC/IEEE 29119-2, “Software and systems engineering – Software testing – Part 2: Test processes.”  This can give you a consistent means of evaluating products, as well as a resource for reviewing those features that you’ll want to use in defining your training program.

Now to get a copy of ISO/IEC 30130.  As noted on the publication, you’ll want to use an authorized distributor since these standards are copyright material.  Order from the Document Center webstore at www.document-center.com with confidence — we’ll been working with both ISO and IEC since the early 1990’s.  Here’s a direct link to the order page for ISO/IEC 30130.

Of course, you can order the standard in either paper format or for pdf download on the website, but perhaps you’re thinking it would be better to have it available in an online portal for multiple users at your organization.  To learn more about our Standards Online service which is an enterprise solution for just this situation, contact our staff members by phone (650-591-7600) or email (info@document-center.com).  They can help you with this or any other standards question or need you may have.  Make us your Standards Experts!

New ANSI/ESD STM3.1 2015 Edition – Ionization

ANSI/ESD STM3.1, “ESD Association Standard Test Method for the Protection of Electrostatic Discharge Susceptible Items – Ionization,” has just been revised.  The new 2015 Edition is available now from Document Center Inc. in both paper and pdf format.  This new update replaces the previous 2006 Edition which is now obsolete.

ANSI/ESD STM3.1 is a part of the Electrostatic Discharge Association’s series of standards developed to help you limit the static charge problems that can plague certain work environments.  This standard provides you with information on air ionization techniques.  Air ionizers neutralize the charge of a given air space.  This is an alternative to a number of grounding techniques covered in various other ESDA publications.

ANSI/ESD STM3.1 is a standard test method and covers 4 types of air ionization:

  • Radioactive emission
  • High voltage corona from AC electric fields
  • High voltage corona from DC electric fields
  • Soft x-ray emission

You’ll see that the publication provides you with test methods and procedures to use when evaluating ionization equipment.  The goal?  To generate meaningful, reproducible data.

ESDA has a number of different types of publications and uses the document number to communicate which is being used in any given standard.  The STM, of course, stands for Standard Test Method.  This is a “definitive procedure for the identification, measurement, and evaluation of one or more qualities, characteristics, or properties of a material, product, system, or process that yield a reproducible test result.”  However, the use of these different designators means that a document number can change from revision to revision.  So the ANSI/ESD STM3.1 has also been known as ANSI/EOS/ESD S3.1.

If you use this standard, you’ll want to get a copy of the new revision.  Order at the Document Center Inc. webstore, www.document-center.com, since we’re an authorized distributor of the ESDA standards.  Here’s the direct link for the order page for ANSI/ESD STM3.1 2015 Edition.  If you have additional questions or want information on our multi-use subscription service, please contact our staff.  We’re available by phone at 650-591-7600 or email at info@document-center.com.  Remember, we’ve been working with compliance documentation since 1982.  Make us your Standards Experts!

SMPTE on the Red Carpet — Awarded an Emmy!

SMPTE, the Society of Motion Picture and Television Engineers, has been awarded an Emmy!  We don’t usually think of standards as a glamour industry, but here it is:  A picture of SMPTE staff member Peter Symes on the podium getting accolades for SMPTE’s work on closed-captioning for Internet content taken from movies and television.  And who was there on the podium as well?  Representatives from Netflix, HBO, Telestream, and W3C.  Nice crowd you run with, SMPTE!

Of course, organizations like SMPTE provide the hidden infrastructure that makes many of our new products and services work.  This work is laborious, taking resources of both manhours and dollars and cents.  So in many ways, SMPTE is also representing those many technical folks who take the time to participate in the standards process.  And the SMPTE Emmy also reminds us that good standardization does rely on industry to provide much of this investment.

What is the SMPTE Emmy for?  It was awarded for the development and publication of the SMPTE Timed Text® (SMPTE-TT) profile.  This is work that was built upon the Timed Text Markup Language (TTML) provided by W3C (the World Wide Web Consortium.  It allows for closed captioning that was done for television broadcasting to be repurposed for Internet distribution.

Another great thing about the development of this standard is that it highlights the participation not only of industry but of the public, especially those with a vested interest in the development of this standard.  SMPTE established a liaison with the Coalition of Organizations for Accessible Technology to make sure that it was appropriate for the requirements of the disability community.

For those of us in the Standards Community, public recognition beyond that offered by the various Standards Organizations themselves is not a common sight.  So congratulations again to SMPTE and thanks to the National Academy of Television Arts & Sciences for the recognition.

You can read more about this prestigious award on the SMPTE website — Here’s a link to the Press Release for the SMPTE Emmy.  It also contains information on SMPTE member Chuck Pagano who was awarded a NATAS Lifetime Achievement Award.  And the press release also mentions a number of SMPTE company members who were honored during the ceremonies.  Really a pleasure to see the public acknowledgement of the contribution of SMPTE and it’s members.

New ISO 18362 – Microbiological Q.A.

ISO 18362, “Manufacture of cell-based health care products – Control of microbial risks during processing,” has just been released.  This new standard provides manufacturers using cell-based material in their health care products with a way to reduce the risk of contamination during processing.  Since cell-based health care products can include a wide variety of materials, the way in which each reacts to various forms of sterilization, etc., can vary widely.  The document addresses the process needed for a risk-based approach for handling these new materials.

CBHP (Cell-Based Healthcare Products) can include materials from human, animal, microbial or plant origin.  Some are able to withstand sterilization, others must be delivered without a guarantee of sterility.  What kinds of materials are we talking about here?  CBHPs include biological heart valves, sutures, tissue patches, corneal tissue and viable skin grafts.  These materials reflect the expanding world of medical science, where the use of biological material is replacing the previous metallic or plastic parts in order to achieve better results and longer lasting solutions.

However, using contaminated materials during surgury can have tremendously negative consiquences.   So manufacturers will want to reduce the risks of this as much possible, increasing the safety and quality of their products according to best practices.  ISO 18362 provides you with a thorough review of all elements necessary to achieve this goal.

It starts with the usual scope, referenced documents and terms and definitions sections.  Clause 4 addresses the quality system elements necessary here, with Clause 5 covering process definition, particularly risk management.  Clause 6 discusses the manufacturing environment, including such areas as manufacturing environment design, the workflow for materials and personnel, and even your HVAC system.

Next come clauses specifically on equipment, personnel, and the manufacture of your product.  Clause 10 is on process simulation and process confirmation, necessary to assure that your system is going to function correctly.  Clause 11 covers the final product release and your test for sterility, if applicable.  Clause 12 covers the final product released for those materials where biological contamination can’t be detected by sterility, for whatever reason.

There are an additional six Annexes in this standard.  Only one is a required section — Annex B on decision trees for the application of risk assessment for cell-based starting materials.  The balance of the Annexes are informational only:

  • Annex A on examples of microbial risks for CBHP,
  • Annex C on containment facilities,
  • Annex D on CBHP starting material itself,
  • Annex E on containment requirements for procured non-sterile starting material prior to entering the manufacturing area, and
  • Annex F on typical elements of a process definition.

A 24-item Bibliography completes the standard.

If you use CBHP’s in your business, you’ll surely want to get a copy of this new standard.  You can order with confidence at the Document Center Inc. webstore, www.document-center.com.  Here’s a direct link to the order page for ISO 18362.

Perhaps you’d like to have multi-user access to this document (and others as well!)  Contact our staff for more information about our Standards Online subscription service.  You can reach them by phone (650-591-7600) or email (info@document-center.com).  And, of course, you’ll find them to be a knowledgeable resource when you have any of the questions that compliance documentation sometimes generate.  After all, we’ve been selling standards since 1982.  Make us your Standards Experts!

IEC 62396-1 Updated for Avionics

IEC 62396-1, “Process management for avionics – Atmospheric radiation effects – Part 1: Accommodation of atmospheric radiation effects via single event effects within avionics electronic equipment,” has just been revised.  The new Edition 2.0 is available from Document Center Inc. in paper format, for pdf download, as a redline version, and as part of our Standards Online multiuser subscription!  Changes are extensive, so if you use this management standard be sure to order your copy now from an authorized distributor like Document Center.

What is IEC 62396-1?  The standard describes the ionizing radiation environment that electronics will be subjected to when in use in aircraft.  Since this type of radiation can affect electronics, the standard provides general approaches to dealing with those effects.  And yes, the standards world is also reviewing the effects of this type of radiation on passengers and crew, even though this standard does not address this issue.

Who should be using IEC 62396-1?  It’s written specifically for avionics systems designers, electonic equipment manufacturers, component manufacturers and their customers.

What will I find in IEC 62396-1?  The standard provides guidance for what’s called “single event effects.”  It describes the details of the radiation environment and the problems this atmospheric radiation can cause.  It shows you the appropriate methods for quantifying single event effect rates in electronic components.  You’ll learn how to expand your system safety methodology to include these rates.  And you’ll be able to demonstrate the suitability of your products for this type of application both at the component and system level.

What’s been changed in the Edition 2.0 for IEC 62396-1?  Of course, Edition 2.0 cancels and replaces Edition 1.0 from 2012.  It is a technical update and the changes are extensive.  The committee does provide you with general guidance on the changes in the foreword to the publication.  However, your Redline Edition will have every detail clearly marked and will be a useful purchase for all serious users of the standard.

The committee points out the following updates:

  • Clause 7 is for guidance only, with the references to level A Types I and II removed.
  • Definitions have been updated.
  • New technology has been added to Annex G.
  • Expansion of concepts for the proposed parts IEC 62396-6, IEC 62396-7 and IEC 62396-8  (solar flares and extreme space weather for the Part 6 in 5.6, atmosphic radiation effects analysis in the system design process in 7.1, and the addition of new particles in 6.2.10 for Part 8).
  • A new Annex H has been added.
  • Changes to 5.3 and 8.2 have been made, as well as clarification to calculating event rates in specific situations.

So now you realize that you need a copy of this new revision.  Head to Document Center’s webstore and order online at www.document-center.com.  Here’s the direct link to the order page for IEC 62396-1.  Have more questions, want a subscription, or prefer to work with a person?  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!

ASTM A276/A276M updated – Stainless steels

ASTM A276/A276M, “Standard Specification for Stainless Steel Bars and Shapes,” has been updated.  The new 2016 Edition has just been released and it replaces all earlier editions, including the previous 2015 Edition from January 2015.  This is an essential standard covering hot- or cold-finished stainless steel bars and shapes.  Reforging and free-machining types are not included.

As with all ASTM standards with a dual designation (A276 and A276M), the specification provides you with measurements both in inch-pound and SI units.  Since values are not  exact equivalents in moving from one to the other, you will need to be consistent in which measurement system to use.

The specification is divided into two major sections, each with it’s own table.  First comes the chemical requirements, listed by UNS numbers.  This gives you the percentage of the various metals that compose each UNS metal alloy type.  Table two provides you with the mechanical requirements, again listed by UNS number.  A short Table 3 covers the response to heat treatment.  And of course, there’s the balance of the technical information — ordering information, manufacture, magnetic permeability, certification and the like.

Those of you who use the ASTM A276/A276M will want to know where to find the changes.  Your committee A01 has provided you with a “Summary of Changes” at the end of the publication.  This is your guide to where to look for your updates.

First, there is a new UNS type added to both Tables 1 and 2.  You’ll find this also in section 4.1.1.6 as a stabilized anneal condition.  There is also a new footnote K in Table 1.  And another revision to Table 1 has been made to Grade S32750 (the additional of footnote L).

Of course, if you use this specification you’ll want a copy of the new 2016 Edition.  You can purchase it in paper format or for pdf download at the Document Center Inc. webstore, www.document-center.com.  Here is the direct link to the ASTM A276/A276M order page.  And as an authorized distributor of ASTM Standards, we also offer the specification as a redline edition or as part of our Standards Online multi-user subscription service.  Just contact us for more information by phone (650-591-7600) or email (info@document-center.com).  We’re here to help you use your standards more effectively and with confident.  Make us your Standards Experts!

Why was AN 960 cancelled again?

What?  The AN 960, “Washer, Flat ,” has been cancelled again?  The new Cancellation Notice 2 for the 21st Revision was just released.  Since AN 960 was already cancelled in September 2011, you may be wondering why they decided to cancel it second time.  Good question!  And yes, the publication is still replaced by NAS 1149, “Washer, Flat.”  So there’s nothing to worry about in that department…

NAS 1149 was originally released in 1990 and adopted by the DoD (Department of Defense) in 1992.  At about the same time, the last Revision 21 for AN 960 was released.  And guess what!  The Revision 21 was deemed “inactive for new design” with the direction to use the NAS 1149 for all new projects (a substitution in all applications.)

So actually the cancellation of AN 960 in 2011 was a transitional cancellation — It still allowed for the use of existing stock until that stock was deleted.  However, a number of years have passed since then.  So the new Cancellation Notice 2 no longer contains that “depletion of existing stock” language.

Instead, the new notice 2 contains the cross-reference tables to help you identify the original AN 960 PIN (Part or identifying numbers) and match it to the replacement NAS 1149 PIN.  It appears to be the same information as before, just without that “escape clause” regarding the use of material that was made to the old specifications.

You can think of this new cancellation notice as “closing the loop.”  It finally completes the transition from one document to the other, and from a now-obsolete air force-navy drawing to an industry specification.

How to get copies of either the AN 960 or the NAS 1149?  Head straight to Document Center Inc.  Our webstore is at www.document-center.com and enables you to order government and industry specifications from one location, as well as both current and obsolete documents.  Here is a link to the order page for AN 960 and a link to the order page for NAS 1149.

And if you have questions, just get in touch with us.  You know, there are very few knowledgeable resources for standards users.  But that is one of the primary missions of Document Center Inc. — to help our customers become informed users of compliance and regulatory information.  So reach out to Document Center by phone (650-591-7600) or email (info@document-center.com) when you need help.  We’re your Standards Experts!

What are FDA Guidance Documents?

What are FDA Guidance Documents?  Why should we use them?  Do they have any legal weight?  These are questions that many organizations have when trying to understand FDA compliance and how the FDA works.  Since FDA Guidance Documents contain a wealth of information that many of our Document Center customers find to be very helpful, I’m going to discuss these publications in general today.  My goal?  To give you a better idea of when and how to use them to improve the way you interact with the FDA.

Guidance Documents are published by the FDA on a regular basis.  They are a methodology they use to communicate information about FDA processes and regulatory requirements.  These publications do not have any legally binding status.  They just are a way for the FDA to let you know what their current thinking is on a topic or how they deal with certain issues or about new processes that you’ll be asked to meet.

One area that FDA guidance documents cover is submissions: how to make your submissions, how your submissions will be reviewed, what they should contain, and so on.  If you’re unfamiliar with what documentation you  need to provide and how it will be processed, guidance documents can explain this to you in general terms.  And occassionally you’ll even get an overview of a specific issue for submissions, as when the “Refuse to Accept Policy for 510(k)s – Guidance for Industry and Food and Drug Administration Staff” was recently released.  This document covers a specific situation for submissions, what it means and how to deal with it.

Another area that’s addressed is compliance, inspection and enforcement.  For anyone with FDA regulatory requirements, understanding how an inspection can take place and what the inspector(s) will be looking for is critical.  Promoting compliance with regulatory requirements over time is an important aspect of the FDA’s mission.  So you’ll find such publications as “Unique Device Identification System: Small Entity Compliance Guide – Guidance for Industry and Food and Drug Administration Staff” available to help you in this regards.

And the other main area that’s covered by guidance documents are about the regulated products or processes themselves.  You’ll find information in these publications on design, production, labeling, promotion, manufacturing, and testing.  They’re a critical communications tool for the FDA.

Some are issued for products that are “hot” as when there was some concern over sterility processes for endoscopes recently.  The FDA issued an update for it’s publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff” to help resolve this issue.  And alongside the FDA’s guidance release, standards organizations also looked to improve processes defined by standardization for this topic.

Others are issued when the FDA or industry perceive that additional information is required to get the desired level of safety and reliability necessary for the public’s well-being.  These can be about very specific topics or more general, like the recent “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings – Guidance for Industry and Food and Drug Administration Staff.”

So, as we mentioned before, FDA Guidance Documents are not a requirement, but they can offer medical device developers and manufacturers a wealth of information to improve the way that you interact with the Administration.  If you’re in this industry, you should monitor these publications on a regular basis.  One easy and effective way to do so is to review the blog.document-center.com on a regular basis.  Just yesterday, I posted the new Medical Device Guidance Documents that were released during the 4th quarter of 2016!  Check it out.

And don’t forget:  Document Center Inc. not only provides you with the standards you’ll need but also gives you access to regulations and supporting documentation necessary to achieve compliance and safety in your product line.  Order the material you need at our webstore, www.document-center.com.  Or if you have additional questions, reach us by phone (650-591-7600) and by email (info@document-center.com).  We’re here to support your quality and compliance requirements!  Make us your Standards Experts!

New IPC-A-610 F Amendment 1

IPC-A-610, “Acceptability of Electronic Assemblies,” has just been updated.  There’s a new Amendment 1 available for Revision F and you’ll want a copy if you use this important electronic assembly standard.  It is being issued in conjunction with a new Amendment 1 for the J-STD-001 so you may want to get both amendments at the same time.

IPC-A-610 is one of the most frequently ordered assembly standards here at Document Center Inc.  So the new Amendment 1 is big news.  Here are the changes as specified by IPC:

  • Reintroduce the Space Shuttle symbol to show where there are different criteria in the J-STD-001FS, “Space Applications Electronic Hardware Addendum” to IPC J-STD-001F, “Requirements for Soldered Electrical and Electronic Assemblies”
  • Revise the Class 2 requirements for vertical solder fill on plated through holes with less than 14 leads to include requirements when there is a connected internal thermal plane
  • Eliminate requirements for BGA voiding for BGA components with noncollapsing balls

Keep up-to-date with your IPC standards.  Rely on Document Center Inc. to provide you with our best-in-class notification services.  It comes free with every standards purchase.  Just order at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600) or email (info@document-center.com) for more information on these important amendments.  We’ve been a trusted distributor of the IPC standards since the 1980’s.  Make us your Standards Experts!