J STD 001 FS Supplement Updated – Space Applications

March 16th, 2015

The “Space Applications Electronic Hardware Addendum to J-STD-001″ has just been revised and is now available from Document Center Inc.  The new J STD 001 F Supplement provides users of the J STD 001 with additional information on  requirements for soldered electrical and electronic assemblies specifically for this application.

Why would you want to use the J-STD-001FS?  The Addendum provides requirements to be used in addition to or possibly in place of those in IPC J-STD-001F.  These special requirements  are centered on the reliability of assemblies that must survive the vibration and thermal cyclic environments of getting to and operating in space.

Do I use the J STD 001 FS as a stand-alone document?  No, it is to be used in conjunction with the J STD 001F.

What’s actually in the J STD 001 FS?  The document begins with a brief scope paragraph.  It then has a series of sub-clauses that describe specific definitions for such things as lead-free tin, lead-free control plan, red plague, and so on.  But the bulk of the document is Table 1, Space Application Requirements.

This table lists specific sub-clauses from the J STD 001 F.  For each of these sub-clauses, the second column of the table covers the changes to the material required for space applicability.  For example, the Supplement contains a sub-clause 1.10.1, on Vision Requirements.   This is a requirement that is not present in the original J STD 001F, but is required in contracts calling out the supplement.  A series of 8 color figures is provided at the end of the document.  They illustrate the level of acceptability of various soldering requirements.

How extensive are the changes included in the Supplement?  There are changes to all clauses 1 through 13 of the original J STD 001 F with the exception of clause 2.

How can I get a copy of this new update?  Order online at Document Center’s webstore, 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 able to get the document in paper format, a single user CD Rom or as a kit with both a paper copy and a single-user CD.  And if you have any questions about these standards or any others that you use, we’ll be happy to help you.  We’re your Standards Experts!

 

New ISO 17480 – Accessible Design for Packaging

March 13th, 2015

ISO 17480, “Packaging – Accessible design – Ease of opening,” has just been released.  This new publication is available from Document Center Inc. now, in paper format, for pdf download, and as part of our multi-user Standards Online subscription service.  It has been developed to address the problems that often face older persons and folks with special needs.  It stands in contrast to standards which make opening packages more difficult in order to protect children!

Accessible design is probably most familiar to people because of the ADA (Americans with Disabilities Act) requirements.  It is the process of designing with the needs of people with disabilities specifically in mind.  A key requirement of accessibility is the concept of independence, being able to access or use something independently.  So improvements in the openability of packaging fits right in with this discipline.

ISO 17480 was written with designers, developers, and evaluators of packaging in mind.  It contains the usual scope, referenced documents and terms and definitions sections.  Clause 4 covers both general considerations and specific requirements for design supporting ease of opening.  Clause 5 shows you how you can evaluate the success of your design and Clause 6 covers conformance.

However, it’s the Annexes that will provide you with significant information for your design challenges.  Annex A is a set of figures and text describing various opening types.  Annex B gives you a set of examples of mechanical evaluation methods (think torque measuring devices for ease of turning for glass containers, etc.)  Annex C discusses the relationship of human strength and dexterity when applied to opening packages.  Annex D provides you with a  consumer panel test used for ease of opening (taken from CEN/TS 15945).  Annex E covers the relation of human cognition to the opening of packages (yes, the standard does cover challenges faced by the elderly!).  You’ll find Annex F helpful too — It’s a designer’s checklist.  And Annex G is the checklist for conformance with the standard itself.  A 28-item bibliography completes the document.

It’s true.  The population is aging!  So designing with physical and cognitive challenges in mind is going to be more and more important as time goes on.  The ISO 17480 provides you with the information and requirements you’ll want to use if you have a product that is sold to this demographic.  So how will you get a copy?  Head to the Document Center website at www.document-center.com to order your copy online.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

New ASTM F2064 2014 Edition released

March 12th, 2015

ASTM F2064, “Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications,” has just been updated.  The 2014 Edition is available from Document Center Inc. now in paper format, for pdf download, and as part of our Standards Online multi-user subscription service.  It is geared for users in the biomedical and pharmaceutical industries, where alginates are now being used in new commercial applications.

What are alginates?  As you might suspect from the name, an alginate is a substance derived from marine algae.  It’s made of polysaccharide and contains calcium, magnesium, sodium and potassium salts.  It’s classified as a hydrocolloid and the most commonly used form is sodium alginate.

The guide contains a listing of those characteristics that affect the functionality of alginates.  You’ll use it to help you select an appropriate alginate for a particular application.  It also provides information on the methods and types of testing you’ll use to confirm the performance of a particular alginate in your application.

Why is ASTM F2064 important?  It’s use in TEMPS (Tissue Engineered Medical Products).  So the information given to help you properly identify your alginate, the physical and chemical considerations and testing you’ll use, the impurities profile of your material, and the performance-related testing needed is essential.

The new ASTM F2064 2014 Edition replaces the previous 2000 Edition that was reapproved in 2006.  Guidance on the location of the changes is not provided by the committee, so you may want to purchase the redline edition of the publication.  This will provide you with a clean copy of the 2015 update and a “marked-up” copy of the original 2000 Edition.  Your changes will be easy to spot.

Now what’s your best way to get copies of the new standard?  Go to the Document Center webstore at www.document-center.com and order your new revision online.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been an authorized dealer of the ASTM standards since the 1980’s, helping folks like you since 1982.  Make us your Standards Experts!

New ISO/TR 10993-33 – Supplement for Part 3

March 10th, 2015

ISO/TR 10993-33, “Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3,” has just been released.  It’s available from Document Center in paper format, for pdf download, and as part of our multi-user Standards Online service.  It will give you an overview of the differences in various regulatory bodies regarding genotoxicity testing.  And it will help you choose what tests to use and provides guidance on the performance of those tests.

What are genotoxicity tests?  They are used to detect compounds that induce genetic damage, either directly or indirectly.  This is necessary because such compounds can be carcinogenic or may create germ line mutations (which can cause human disease).

The ISO/TR 10993-33 has the usual scope clause and then dives directly into the issue of what tests are commonly recognized for use by most regulatory agencies.  This general information is linked to the various clauses in the technical report, so for bacterial reverse mutation test the user is directed to clause 6 and OECD 471.  Clauses 4 and 5 cover an overview of both in vitro and in vivo tests.

Then the report clauses 6 to 11 cover six different tests.  Each is given a general overview, preparations, test conditions, procedure and data and reporting sections.  The six tests are:

  • Bacterial reverse mutation assay
  • In vitro mammalian chromosome aberration test
  • In vitro mammalian micronucleus test
  •  In vitro mammalian cell gene mutation test using mouse lymphoma (L5278Y) cells
  • In vivo mammalian erythrocyte micronucleus test
  • Chromosome aberration test (in vivo)

A 33-item bibliography completes the publication.

As you can see, the document is highly technical, but offers the user detailed information that is not found in the shorter ISO 10993-3.  Indeed, the bulk of the ISO/TR 10993-33 supplement is devoted to the tests themselves which will surely add clarification and detail to anyone currently using the Part 3.

Now you’ll want to get a copy.  You can order online at the Document Center 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’ve been an authorized dealer of the ISO standards since the early 1990’s and selling standards from our Silicon Valley headquarters since 1982.  Make us your Standards Experts!

New IPC 7092 – The embedded component process

March 9th, 2015

IPC 7092, “Design and Assembly Process Implementation for Embedded Components,” has just been released.  You can purchase your copy of this new publication from Document Center Inc. now.  If you’re a manager, designer or technician who works with embedded components, you’ll want to get a copy.  It’s a useful guide on how to the implementation of an embedded component process.  It also helps with inspection techniques, testing processes, and reliability validations.

The IPC 7092 is a response to the changing realities of printed circuit board assembly practices.  With the issues surrounding ROHS and the need to eliminate certain substances from electronic components, there’s a move to embedding both active and passive components into the circuit structure.  And if you’re going to take that route, you’ll need to do so early in the design process.

What are the benefits?  Higher component density and/or reduced size footprint, lower assembly costs, and improved performance.  But it’s not without challenges, and that’s where IPC 7092 comes in.

After the usual scope and referenced documents section, Clause 3 provides you to a lengthy introduction to the topic.  You’ll get a thorough review of terms and definitions, the technologies involved, materials involved, cost analysis, product safety design and case study/decision making.  Clause 4 covers component considerations and Clause 5 is a discussion of the materials involved.  Clause 6 covers the process itself and it’s characteristics.  Clause 7 provides you with information on the mounting base and on board stackups.  Then Clause 8 moves into design considerations, while Clause 9 reviews testing requirements.  Clause 10 is a review of post assembly considerations and lastly Clause 11 provides you with supplier selection information.

Two Annexes complete the standard.  Annex A provides a history of the usage of embedded components.  Annex B covers embedded component test coupons.

Why use the IPC 7092?  When you make the decision to embed components into your board, there are many factors to consider.  These range from the components and boards involved to the level of precision and control within your manufacturing processes.  The standard provides you with the information you’ll need to make good design decisions.

Now to get a copy!  The standard can be purchased from Document Center Inc., an authorized dealer of the IPC publications.  It’s available in paper format, as a CD Rom, and as a Kit (a set that includes both the paper copy and the CD Rom).  With IPC standards, you’ll always want to remember that the CD format has had the printing function suppressed.  So if you need a hardcopy, you’ll need to purchase it.

Order at the Document Center website, 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 selling and supporting the use of standards since 1982.  Make us your Standards Experts!

ISO and China team up to end standards piracy!

March 6th, 2015

Standards piracy — it’s a thorn in the side of most standards developing organizations.  And as many of you know, I’m constantly finding websites that sell standards illegally.  This means in my role as President of Document Center Inc., I work closely with a number of standards developing organizations to help shut down these sites for pirated standards.  In fact, yesterday I found one that included the ANSI logo as part of it’s branding in the header information!

Lately I’ve noticed that when I identify sites involved in standards piracy, they get taken down rather quickly.  How is this happening?  Turns out that the Standardization Administration of China (SAC) and ISO have teamed up to address the problem.  And since the primary offenders are located in China, this is one way to curb the problem.

According to Guo Hui’s news piece at the ISO website (posted on March 4th), a special campaign was set up in 2010 to combat the problem of Internet piracy of intellectual property in general.  Dubbed “Sword Net Action,” the initiative started to focus specifically on standards in 2013.

Why the special attention on standards piracy?  First, there were two (famous in the standards community, by the way) cases brought to trial in China.  One was against a Mr. Wang and the other against a Mr. Chen.  They are notorious for using multiple front ends to dish up the same web server information, touting the sale of standards at “too good to be true” prices.  Both got prison terms which were not too long, but which generated plenty of local publicity.

Then, the desire of the Chinese government to promote trade, which means using valid documents and playing nicely with the international standards community, must have certainly have had an impact as well.  World Standards Day in 2014 was used as an educational event to let Chinese standards users understand the rationale for the use of authorized editions of standards.

Net result?  Standards are now on the list of “ten targeted cases” of the “Sword Net Action” campaign.  It may still be a game of “whack-a-mole,” but those moles are getting whacked at an increasing rapid pace!  This is a real tribute to the desire of the Chinese government and it’s standardization arm to promote IP protection to this type of material.

If you’re interested in this topic as much as I am, I urge you to read the ISO News Release for yourself.  It’s a great synopsis of what’s been happening in China.  And it again discusses the size of the market for standards and the real dangers that pirating sites like these pose.  Both ISO and SAC are to be commended for their joint efforts to end this despicable and dangerous practice.

Let me know if you happen to come upon any standards piracy sites.  I’ll forward the information on to the appropriate contacts.  You can reach me at info@document-center.com.

New ISO/IEC 33001 updates ISO/IEC 15504 series

March 5th, 2015

The ISO/IEC 33001 standard has been released, representing the first step in moving the ISO/IEC 15504 series over to the new ISO/IEC 33000 numbering scheme.  There’s a total of five new publications in the set and we’ll discuss them here.  This is a complete technical and conceptual overhaul of the series on process assessment and offers users both in and out of the IT community an in-depth review of the topic.  It is part of the SPICE (Software Process Improvement and Capability Determination) initiative.  It can be used by both software developing organizations and by those who outsource such services.

One thing to note is that all publications in this new series are first releases but are numbered as 2nd Editions.  However, the migration path of the information from one set of documents to the other is not linear at all!

ISO/IEC 33001, 2nd Edition, “Information technology – Process assessment – Concepts and terminology”

This is your overview document, directly replacing all of ISO/IEC 15504-1 and clauses 3 and 4.1 of ISO/IEC 15504-7.  It provides you with the usual scope and referenced documents sections.  Then an extensive definitions clause 3 covers processes, process management, process assessment and process modeling terms.  Following this, clause 4 gives you a review of the structure of the new ISO/IEC 33000 series of standards.  Then clause 5 discusses the concepts involved for process assessment of any kind.

The last three clauses cover the concepts of assessment of process capability, of conformance,  and of conformity assessment.  It also includes an annex with a table showing the relationship between the old series and the new.  It is an exceptional review of the topic of this tool for process improvement.

ISO/IEC 33002, 2nd Edition, “Information technology – Process assessment – Requirements for performing process assessment”

The update replaces specific clauses of both ISO/IEC 15504-2 and ISO/IEC 15504-7.  It addresses the concept of assessment itself, providing the user with requirements to achieve objective, repeatable and consistent results.  It also gives you information on the various classes of assessment (1, 2, and 3).  Annex A includes a table with information on the categories of independence of bodies and personnel who perform an assessment.  And Annex B provides you with example content that might be included in an assessment report.

ISO/IEC 33003, 2nd Edition, “Information technology – Process assessment – Requirements for process measurement frameworks”

ISO/IEC 33003 also replaces parts of ISO/IEC 15504-2 and ISO/IEC 15504-7.  It is a requirements standard, giving you the tools to set up a measurement framework for each process quality characteristic.  You’ll do this by defining a set of process attributes for each.

The standard takes you through conceptualization, construct definition, operationalization, construct specification examination, rating process attributes, aggregation, and sensitivity analysis.  Then it covers the requirements for validating and verifying conformity for these frameworks.  Annexes cover a terminology map, reflective or formative construction specification, statistical validation methods, and how to implement the requirements for process measurement frameworks.  Finally a 45 item bibliography completes the document.

ISO/IEC 33004, 2nd Edition, “Information technology — Process assessment — Requirements for process reference, process assessment and maturity models”

Again, we have a partial replacement of the 15504 Parts 2 and 7.   This time we’re reviewing the modeling requirements involved.   The standard covers process reference models, process assessment models, and maturity models.  It concludes with a 3-item bibliography.

ISO/IEC 33020, 2nd Edition, “Information technology — Process assessment — Process measurement framework for assessment of process capability”

And the new ISO/IEC 33020 cancels and replaces the clause 5 of ISO/IEC 15504-2.  Here we’ve got the document that provides you with the requirements for measuring your process capability in accordance with ISO/IEC 33003.  You’ll use it to confirm that the process you use is able to consistently meet current or projected business goals.

The standard is composed of the usual scope, referenced documents and definition sections.  An overview of the topic follows.  Then there’s lengthly coverage of the process measurement framework, including various process capability levels and process attribute rating methods.  Annex A reviews the conformity issue, with references to the ISO/IEC 33003.  Annex B gives you an example of a process performance model.  A 7-item bibliography completes the document.

Of course, now you need copies.  So head to Document Center’s webstore at www.document-center.com and order online.  Copies are available in paper format or for pdf download.  If you’d like more information or would like multi-user access, contact our staff.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

IEC 62366 Replaced by IEC 62366-1

March 4th, 2015

IEC 62366 for medical device usability engineering has been replaced by two new publications.  The first, IEC 62366-1, is available now.  The second, IEC 62366-2, is still in preparation.  You can get your copy of IEC 62366-1, “Medical devices – Part 1: Application of usability engineering to medical devices,” from Document Center Inc.  It’s available in both paper and pdf formats and can be included in our Standards Online multi-user subscription service as well.

This change divides the IEC 62366 into two parts.  Part 1, as noted above, is on the application of usability engineering to medical devices.  Part 2 will be titled “Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” when it is released.

Let’s take a look at the new IEC 62366-1 to see how the document has been revised.

Part 1 has been updated to include more up-to-date concepts of usability engineering and to streamline the process.  The ties to ISO 14971 have also been strengthened for the application of risk management to the safety related aspects of medical device user interfaces.

What will you find in this standard?  After the usual scope, referenced documents and definitions clauses, the IEC 62366-1 discusses the principles of usability engineering.  This is an overview of the process, the usability engineering file, and how to tailor your efforts.

The next clause (clause 5) covers the concept of the usability engineering process in depth.  It takes you all the way from preparing your user specification to the final evaluation of your user interface.

Five Annexes provide you with information that you’ll find to be very helpful.  Annex A gives you general guidance and the rationale for usability engineering.  Annex B is a set of hazardous situations related to usability.  Annex C is a requirement, with information on the evaluation of a user interface “of unknown provenance.”  Annex D gives you a list of the types of medical device usages, along with examples.  And Annex E is a table that shows the relationship of the IEC 62366-1 clauses to the ISO/TR 16142‘s essential principles.

Lastly, a 46-item bibliography and an index of defined terms complete the standard.

FYI:  The Part 2 will include tutorial information to assist manufacturers comply with Part 1.  It will offer a more detailed description of the usability engineering methods you can use.  And it will extend IEC 62366 principles beyond the safety-related aspects of medical device user interfaces.

Now to get your copy of this new update.  You can order online at the Document Center 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’ve been an authorized distributor of IEC standards since the 1990’s and have been providing standards to our customers since 1982.  You’ll rely on Document Center Inc. to assist you with all your requirements relating to this type of conformance information.  Make us your Standards Experts!

New AAMI EQ89

March 3rd, 2015

There’s a new AAMI EQ89, “Guidance for the use of medical equipment maintenance strategies and procedures,” and it’s available now from Document Center Inc.  This timely standard helps healthcare professionals review the various strategies available for dealing with the issue of efficient, effective, and timely maintenance of medical equipment.  It gives you an overview as well as the pros and cons of each procedure.

Why a standard on maintenance strategies?  There are a number of factors that have driven the development of this document.  But the overarching concern is the need for the healthcare technology management (HTM) industry to have a consistent process for developing maintenance protocols.

Why is this needed?  Some devices do not have maintenance guidelines.  And sometimes test equipment used in the original procedure is no longer available or out-dated.  Certainly technology is changing daily and may have an impact on how equipment is maintained.  Other factors can be the determination that existing protocols are no sufficient, not appropriate to the situation where the device is used, or not as efficient as possible.

The AAMI EQ89 covers the following topics:

  • Developing the strategy itself
  • Creating alternative procedures
  • Types of maintenance strategies
  • Documenting findings and repairs

Three Annexes provide you with additional information on benchmarking, regulatory requirements, and references.

If you’re in charge of maintenance at a healthcare facility, or have an interest in the topic, you’ll want to get a copy of this new release.  You can order your copy online at the Document Center webstore, www.document-center.com.  It’s available in paper format or for pdf download.  And if you’re interested in multi-user access, contact our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

When you use Document Center Inc. you’re assured that the copies you purchase are authorized editions, with support services available like no-charge notification service to monitor your standard.  We’ve been selling standards since 1982, so make us your Standards Experts!

New MIL-STD-750/2 Revision A

March 2nd, 2015

MIL-STD-750/2, “Mechanical Test Methods for Semiconductor Devices Part 2: Test Methods 2001 through 2999,” has been updated.  The new Revision A is available now from Document Center Inc.  You can get your copy in paper format, for pdf download and as part of our multi-user Standards Online service.  If you use this standard, you’ll need to comply with the changes in the new edition by 3/23/2015.

This standard is part of the MIL-STD-750 series, a main overview document and five parts, each providing you with specific semiconductor tests.  This format was adopted in 2012 when the tests in the standard became too numerous for a 1-volume document.

Volume 2 applies only to semiconductor devices, with requirements for tests used to meet contracts issued by the U.S. Department of Defense.  However, the MIL-STD-750 series is used widely across industry here in the U.S. and elsewhere, so if you’re part of the semiconductor industry, you’ll want to pay attention to this new update.

As you probably already know, the document is comprised of a series of clauses withgeneral requirements.  But the bulk of the standard is the actual tests themselves.  Each test is given a number, with the revision level being noted by a period and the revision number.  All tests in this second part on mechanical testing start with 2000.  So test 2017.3 is test method 2017, revision 3, on die attach integrity.

Let’s review the test methods that have been updated in this new MIL-STD-750/2 Revision A:

  • Test Method 2071 (2071.8), Visual and mechanical examination
  • Test Method 2072 (2072.9), Internal visual transistor (pre-cap) inspection
  • Test Method 2076 (2076.5), Radiography
  • Test Method 2101 (2101.4), Destructive physical analysis for diodes

Each of these test methods have been updated, with both new and updated information and figures.  A listing at the beginning of the standard provides you with information on the exact clauses where the changes occur.

Now to get your copy of this new release.  Head to the Document Center webstore at www.document-center.com and order online!  Or contact our staff by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  We’ve been supporting both the defense contracting community and the semiconductor industry since 1982, providing standards and support services from our Silicon Valley location.  You should make Document Center your Standards Experts too!