IPC-T-50 M Released

IPC-T-50, “Terms and Definitions for Interconnecting and Packaging Electronic Circuits,” has just been updated.  The new Revision M is available from Document Center in paper format, for pdf download, in CD Rom format, and as a kit with both the paper and CD Rom copies included.  As IPC says, the IPC-T-50 defines the “language of an industry.”  It allows users to understand terms both by written definitions and the use of illustrations for better clarity.

What’s new in the IPC-T-50 M?  There are over 220 new or revised terms.  The new definitions include including terminology for conformal coatings, potting and encapsulation processes, stencil design, statistical process control, and flexible printed board technology.  And some out-of-date terminology has been removed from the 123-page publication as well.  This new edition replaces the now-obsolete Revision K from 2013, so it’s been about 2 years since the last revision.

Who should be using the IPC-T-50 M?  OEM, EMS or ODM Companies will all find the document can facilitate communications between staff and customers as well as ensuring a common understanding within the organization itself.

What about acronyms?  Acronyms used in the electronics industry are addressed in the publication’s Annex.  This is an invaluable aid in an industry beset by the use of acronyms!

What format of the IPC-T-50 is right for me?  Your document comes in single-user editions by default.  So while the CD Rom and the paper copy have a certain amount of portability, the pdf copy is definitely for the use of 1 person only.  And you’ll need to remember that electronic copies of the IPC standards do have the print function disabled.  So when using either the CD Rom or the pdf formats, your electronic copy will be your only copy, no printing allowed.  So make your choice based on these limitations.

Where can I get my copy of the IPC-T-50?  This is a copyright publication and must be purchased from an authorized distributor like Document Center Inc.  Order online at our webstore, www.document-center.com.  Or use this link to the order page for IPC-T-50 now.  Have questions and want to work with a real person?  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our staff is well known for being responsive — Your call or email will be answered by someone with the expertise to answer any questions you might have.  Make Document Center your Standards Experts!

New ISO 10160 – Interlibrary Loan

ISO 10160, “Information and documentation – Open Systems Interconnection – Interlibrary Loan Application Service Definition,” has just been updated.  And since I’m participating in the annual Standards Roundtable at the Special Libraries Association Convention today, I’m featuring this new revision!  While it’s a highly technical document, it does highlight the degree to which library functions have been automated.  The library community has been using online tools for many years now.  So while the ALA (American Library Association) still provides the paper form 2002 for ILL, most libraries use computerized systems.

What is Interlibrary Loan (ILL)?  This is a system used within the United States that allows one library or library system to “borrow” a copy of a publication from another.  We use the Interlibrary Loan Code for the United States as the protocol for such transactions.  There are also requirements for Canada, other jurisdictions and of course, internationally.

How is the ISO 10160 used?  ISO 10160 provides a set of Application Layer services used in computer-based systems that allow for libraries to make loans in an Open Systems Interconnection (OSI) environment.  Why?  So that software products from a variety of suppliers using various levels of sophistication and technologies can communicate seamlessly.  This means that different libraries can implement different solutions and still “communicate” back and forth.

Why are libraries interested in this type of standardization?  ISO 10160 satisfies a number of objectives.  These include control — managing the transaction and monitoring the document in question — and minimizing costs.  Also, the standard is based on current ILL practices which means that libraries will have an easy time porting old paper-based systems to the current computer-based procedures.

Do librarians write this standard?  Participation in ISO Technical Committee 46 (which is in charge of the ISO 10160) is handled in the U.S. by NISO, the National Information Standards Organization.  NISO membership is composed of both librarians and others from the various companies that provide the library community with products and services.  Participation from librarians in the development of a standard like ISO 10160 is essential, since implementation of the publication affects the every-day activities that any library will perform.

What about the document itself?  The ISO 10160 2015 Edition is a technical update to the 1997 Edition and it’s Amendment 1.  It’s 84 pages in length but with the same basic format as previously.  The clauses are stable, with the usual scope, reference documents, and terms and definitions sections starting off the publication.  And Clauses 4 on abbreviations and Clause 5 on conventions are still there as well.  Clause 6 on the service model has the same sub-clauses as before, as does Clause 7 on the definition of services.  However, for these two clauses, the pages devoted to the topic have substantially increased.   In the 2015 Edition, Annex A begins on page 66 while the previous 1997 Edition’s Annex A starts at page 50.  While some of this is probably due to the reformatting of the standard from two columns to one, most is likely on account of integrating the information from the previous Amendment 1 (a new Annex D to include Canadian protocols) into the body of the standard.  Which brings us to the final change.  The 2015 Edition has Annexes A and B plus the bibliography (which is no longer considered an Annex) instead of the previous Annexes A through D.

Now, the big question:  How do you get a copy of ISO 10160?  Since all ISO standards are copyright documents, you must purchase a copy from an authorized distributor like Document Center Inc.  Search for and buy any of these publications at our webstore, www.document-center.com.  And here’s a direct link to the ISO 10160 order page.  They’re all available in both paper and pdf format, and can be included in your Standards Online multi-user subscription service too.  We’ve been providing folks like you with standards since 1982, and participating in SLA since the 1980’s as well!  The library community has been going through big changes since that time and Document Center Inc. is happy to have been a part of that transformation.

 

New EN 45502-1 2015 Edition – Implantable Medical Devices

The EN 45502-1, “Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer,” has just been updated.  The new 2015 Edition replaces the previous 1998 Edition which is now obsolete.  European nations have until 4/20/2016 to adopt the new revision.  All conflicting or duplicating national standards must be withdrawn by 4/20/2018.

EN 45502-1 is the European standard for general requirements for the basic safety of active implantable medical devices.  To reduce the risks of mishandling and/or misuse, the standard also provides users with comprehensive information on markings, instructions, and other documentation requirements to be supplied by manufacturers for their customers.  At this time, there are three additional parts of the series.  One is for bradyarrhythmia devices (cardiac pacemakers).The second  specifies additional requirements for devices for tachyarrhythmia  (like implantable defibrillators).  And the third covers implantable devices for cochlear and auditory brainstem implant systems.

What’s new in the 2015 Edition of EN 45502-1?

  • It’s been updated to meet the requirements of the modified definition of AIMD (Active Implantable Medical Device) which now includes “software.”
  • The definition of “state of the art” has been updated.
  • Some usability issues are now addressed.
  • Links to information security have been implemented.
  • The elements of the standard have been harmonized to match EN 14971 from 2012.
  • Clause 14 has been updated and improved.
  • Clause 20 has also be updated and improved.
  • Clause 22 has been updated and improved, particularly for ultrasonic diagnostic devices.

You will also want to note that the Annexes A and B from the 1998 edition have now been consolidated and updated as the new Annex ZZ.  This Annex is important as it provides you with the information required to map the clauses of the EN 45502-1 with the essential requirements of Directive 90/385/EEC (as modified by amendment 2007/47/EC) on implantable medical devices.  You’ll use this ZZ mapping to insure that your device meets the legal requirements for selling it in Europe.

Where can you get a copy of the EN 45502-1?  You’ll want to purchase your copy of this copyright publication from an authorized dealer like Document Center Inc.  You’ll have choices, since legal copies are published by each country in Europe.  Right now you’ll be able to get the EN 45502-1 in paper format as BS EN 45502-1 (Here’s the link to the order page for BS EN 45502-1).  You can get it in both paper format and as a pdf download in the SS EN 45502-1 Edition (Here’s the link to order SS EN 45502-1).  It’s also available for multi-user access using our Standards Online service.  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

You can always order standards from Document Center Inc. at our webstore, www.document-center.com.  We’ve been selling standards since 1982 from our Silicon Valley headquarters.  Make us your Standards Experts!

New ISO/IEC TR 29194 – Biometrics

ISO/IEC TR 29194, “Information Technology – Biometrics – Guide on designing accessible and inclusive biometric systems,” has just been released.  This new Technical Report is a companion to ISO/IEC 24714-1 General Guidance document.  It reviews biometrics in relationship to the limitations of potential target populations.  Since biometric identification systems are intended to be used effectively and with minimum discomfort, potential exceptions need to be considered.

Thus, ISO/IEC TR 29194 sets up a taxonomy to help designers of biometric systems identify and account for human limitations.  These include the following areas:

  • (Inability to) Perceive visual information
  • (Inability to) Perceive auditory information
  • (Inability to) Perform motor actions
  • (Inability to) Present physiological attribute
  • (Inability to) Apply instructions due to mental impairment
  • (Inability to) Follow guidance due to cultural discrepancies

For each of these issues, the report provides examples or definitions for better understanding.  Then each is given a recommendation and, in some cases, additional resources.  This means that for the subject of inability to perceive visual information, for example, there are specific recommendations regarding terminal/scanning requirements for use of the finger,  iris, signature and so on.  This means a better design to serve that segment of the population with some degree of visual impairment.

You’ll also find the Annex A to be of great assistance.  It reviews and details the various types of impairments that can be found within the population in general.  This will help you define potential limitations.  And the report closes with a 9-item bibliography for further clarification.

Now you’ll want to get a copy of the new ISO/IEC TR 29194.  Be sure that your source is an authorized distributor like Document Center Inc.  You can get a copy in either paper format or for pdf download at our webstore, www.document-center.com.  Here’s a link directly to the order page for ISO/IEC TR 29194.  Want multi-use access?  Contact our staff for more information.  They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards since 1982, so make us your Standards Experts!

New IEC 61760-4 – Surface Mount Technology

IEC 61760-4, “Surface mounting technology – Part 4: Classification, packaging, labelling and handling of moisture sensitive devices,” has just been released.  The new standard extends the classification and packaging methods included in J-STD-020 and J-STD-033.  It is intended to be used for these types of components where the two J STD’s are not required or appropriate.

It’s been developed because the mandated use of lead-free solder alloys has resulted in higher tempertures during reflow soldering processes.  So the sensitivity of components to this heat when being exposed to moisture before soldering has become an increasingly important factor.  While other standards have addressed this problem for plastic encapsulated semiconductors and the like, there has been no guidance for other types of components.

IEC 61760-4 is used for devices intended for reflow soldering (like surface mount devices) including specific through-hole devices.  It provides you with a classification system for such moisture sensitive devices.  These moisture sensitivity levels are related to soldering heat.  Packaging, labeling and handling requirements for each level are then issued.

However, you will not use IEC 61760-4 for semiconductor devices themselves.  Nor will you use it for devices for flow (wave) soldering.

Your standard is divided into various clauses, starting with the usual scope, referenced documents and definitions sections.  The body of the IEC 61760-4 covers the following 6 topics:

  • General information,
  • Assessment of moisture sensitivity,
  • Test procedures,
  • Requirements for packaging and labeling,
  • Handling moisture sensitive devices, and
  • Drying.

There are also 4 informative annexes.  Annex A covers moisture sensitivity of assemblies, Annex B is on mass/gain loss analysis, Annex C is for the baking of devices, and Annex D reviews moisture sensitivity labels.  A 13-item bibliography completes the document.

As I’ve noted before, IEC standards are covered by the laws of copyright and need to be purchased from an authorized distributor like Document Center Inc.  Go to the Document Center webstore at www.document-center.com and order your copy in either paper format or for pdf download.  Or go straight to the order page for IEC 61760-4 right now!  Should you prefer, all IEC standards are available as part of our Standards Online subscription service for multi-user access.  Just get in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  (Want to take a look at our service?  Just register at demo.document-center.com).

Remember, here at Document Center we’ve been working with standards since 1982.  Make us your Standards Experts!

ISO 16061 2015 Edition – Surgical Instruments

ISO 16061, “Instrumentation for use in association with non-active surgical implants – General requirements,” has just been updated.  This standard provides users with requirements for surgical instruments used with non-active implants.  These are things like scissors, cannulae, location guides, spreaders, and the like.  These instruments may be linked to a power drive, however only the instruments themselves are covered in this document.

The new ISO 16061 3rd Edition from 2015 replaces the previous 2nd Edition from 2009, which is now obsolete.  It is a technical update.  The European adoption of the standard (EN ISO 16061) has also been updated to a 2015 Edition as well.

When you use this standard, you’ll find all the requirements for the following areas:

  • Intended performance,
  • Design attributes,
  • Materials,
  • Design evaluation,
  • Manufacturing,
  • Sterilization,
  • Packaging, and
  • Information to be supplied by the manufacturer.

These areas are in many cases defined by reference to other standards.  You’ll find Annex A to be particularly helpful too.  It contains a long list of typical instruments.  Then it lists either the standards for materials that will be acceptable for each application or a reference to a specific tabular entry in one of three tables with the material requirements for the instrument in question.

What kinds of surgical instruments are not covered by ISO 16061?  The standard is not used for instruments for dental implants, transendodontic and transradicular implants, and ophthalmic implants.

How can you get an authorized copy of the new edition?  You’ll want to order from an authorized dealer like Document Center Inc.  There are a number of sites proporting to sell ISO standards — Not all of them are legitimate.  However, Document Center Inc. has been selling ISO standards under contract since the 1990’s.  You can order all the standards you need with confidence at our webstore, www.document-center.com.  For your convenience, here’s a link directly to the order page for ISO 16061.  It’s available for delivery in paper format or as a pdf download.

Would you prefer to have subscription access to this ISO standard?  Ask our sales staff about our Standards Online service which provides 24/7 availability to your organization.  They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Remember, Document Center Inc. has been selling standards since 1982.  Make us your Standards Experts!

ISO/TR 12310 – Health Informatics Conformance

ISO/TR 12310, “Health informatics – Principles and guidelines for the measurement of conformance in the implementation of terminological systems,” has just been released.  This new Technical Report is a milestone in the efforts to provide EHR (Electronic Health Record) users with consistent data from system to system.  Stakeholders now have guidance on how to determine what a terminology system is and how to judge if it has been implemented in a correct and consistent manner.  This in turn promotes interoperability, an essential component of an effective EHR system.  The principles of this technical report can be extrapolated wherever a move to conformance standardization is of benefit.

The ISO/TR 12310 is based on current work occurring in Canada as well as that of the IHTSDO (International Health Terminology Standards Development Organization) and HL7’s Vocabulary Committee.  It is not only intended for a commercial audience but also for government stakeholders.  It is expected to facilitate the development of policies and practices from a local level to the international arena.

The 34-page report is especially broad in it’s approach.  It starts with the usual scope clause but instead of a referenced documents section, clause 2 covers the report’s objectives.  Clause 3 returns to the usual format of a definitions section.  Then the publication moves into the heart of the matter.

Clause 4, “Purposes for conformance,” discusses the benefits of using a conformity scheme.  And clause 5 covers the four steps of the conformance process itself.  Additionally, you’ll learn what the various levels of required compliance are so that there’s no confusion over a recommendation vs. a requirement and so on.

Next the report covers how to review existing material prior to instituting the new conformance system itself.  This is referred to as “artefact” considerations, in this case codes that are already in use.  Clause 7 focuses in on the user experience that will be impacted by the conformance system itself: data capture, exchange and analysis.  It takes a look at both coded and non-coded information for a complete picture of the situation and proposed new outcome.

Clause 8 covers sharing and persisting conformance expectations.  This is a discussion of how to present specific conformance requirements for use by developers and by assessment schemes.  It helps you understand why some requirements are actually included as XML or CSV statements rather than as documentation “representations.”

The ISO/TR 12310 then addresses the need of those who are compliant to this type of specification to have a way to assert conformity.  It discusses various levels of conformity, assumptions, variations and so on.  Clauses 10 and 11 show you how to evaluate and verify these types of conformance statements.   A review of other considerations like comparing conformance statements and IP issues that can arise finish up the report.  A two-item bibliography is included.

This new Technical Report is a great overview of conformance documents and how to create and use them.  It will be of great value to the Health Informatics industry, but has something to offer others considering developing or implementing such schemes.

Of course, to get your copy of ISO/TR 12310, you’ll need to purchase a copy from an authorized distributor like Document Center Inc.  Why?  This is copyright information that comes with specific rights and responsibilities.  You can purchase your copies in paper format or for pdf download with confidence from the Document Center Store at www.document-center.com.  Want to go directly to this technical report?  Here’s the link for ordering ISO/TR 12310.

Have more questions?  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to help you with all your conformance issues.  Make us your Standards Experts!

AMS 2770 Revised

AMS 2770, “Heat Treatment of Wrought Aluminum Alloy Parts,” has just been revised.  The new Revision M is available from Document Center Inc., an authorized distributor of the AMS standards.  However, we would like to let you know that another draft edition (the future Revision N) is currently in process.

What is AMS 2770?  AMS 2770 is the premier specification for the engineering requirements for heat treatment of parts.  It’s used by part fabricators (users) or their vendors and subcontractors.  It covers the following aluminum alloys: 1100, 2004, 2014, 2017, 2024, 2098, 2117, 2124, 2219, 2224, 3003, 5052, 6013, 6061, 6063, 6066, 6951, 7049, 7050, 7075, 7149, 7178, 7249, and 7475.

What changed in this new Revision M for AMS 2770?  The footnotes to Table 2 were revised.

What’s being reviewed for the new Revision N if it’s accepted?  It looks like there’s some additional changes to the footnotes in Table 2 that are under discussion right now.

How can you get a copy of AMS 2770?  This is a copyright standard and must be purchased from an authorized distributor.  Document Center Inc. has been a licensed dealer of SAE standards since the 1980’s.  You can order both paper format and pdf download copies from our webstore, www.document-center.com. Here’s the link to order the AMS 2770 now.  Need more help?  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks like you since 1982.  Make us your Standards Experts!

Changes to BPVC 2015 Sections X, XI and XII

The BPVC, “ASME Boiler and Pressure Vessel Code,” is being revised.  The new BPVC 2015 Edition will be available in July and you’ll want to pre-order your copy from Document Center Inc. now.  This new update replaces the previous 2013 Edition which is now obsolete.  You’ll notice that the set is now updated on a two year schedule, which means that there are not any addenda released any more.  The interpretations are still available and are posted online.

ASME has made a list of key changes available to ASME dealers like Document Center Inc., so we’re letting you know about them in advance of the release in July.  Here are the main things to look for in your new editions of the Sections X, XI and XII:

For Section X, Key changes have occurred in Code Case 2820, Composite Pressure Vessels for High Pressure Fluids.

For Section XI, Key changes have occurred in:

  • Appendix D
  • Article A-3000 for K Calculation Methods for Surface and Subsurface Flaws
  • Through-Wall or Through-Weld Leakage in Class 1 Components
  • A new code case has been released to replace N-629.  This has also revised Appendix A, A-4200 for KIa Fracture Toughness Determination.

For Section XII, Paragraphs in Part PR have been changed to:

  • revise requirements for pressure relief devices
  • update 1-1.4(a), 1-1.4(c)(3)
  • delete 1-1.4(d)(11)
  • add a definition of “Material Type Report” to Appendix III and III2.
  • revise the definition for “Dynamic Load Condition” in 1-1.4(c)(3)
  • update Modal Appendix 1 for Allowable Stress Criteria

We know that you’ll need copies of the new 2015 Edition of the BPVC.  Document Center Inc. is your authorized dealer and you can pre-order your copies now.  Go to our order page for the BPVC now!  Should you have any questions, just contact the Document Center staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

New ISO 22322 – Emergency Warning

ISO 22322, “Societal security — Emergency management — Guidelines for public warning,” has just been released.  It’s yet another example of the expansion of standardization into non-technical and management areas.  It’s part of the ISO 22300 series from Technical Committee 92 on Security.  You can get your copy of this new release from an authorized distributor like Document Center Inc.

ISO 22322 has been developed in response to the challenges of natural disasters, terror attacks, and other major incidents world-wide.  It’s goal is to help emergency organizations develop effective and timely communications in order to save lives, protect health and minimize disruptions.  So it reviews and defines requirements for all steps in warning plans, for both setting up the system and setting up the process.

What does ISO 22322 cover in terms of public warning systems?  Clause 4 starts with a general overview and then covers framework design issues:  Hazard monitoring, warning dissemination, and responsibilities.  You’ll learn how to identify public warning objectives and implement your process.  And of course the last section is on evaluation and continuous improvement.

What does ISO 22322 cover in terms of the public warning process itself?  Clause 5 again starts with a general overview.  It then turns to the hazard monitoring process and the steps you’ll need to take to implement it.  There’s a section on operational decision-making.  Then there’s a complete section on the warning dissemination process.   Clause 5 closes with a section on human factors considerations.

ISO 22322 is arranged as a series of listed steps, with many sections logically arranged as a series of action items or responsibilities.  So you’ll get concrete recommendations for the information that should be included in a warning or how to identify what area should get a warning, for example.

In addition, in Annex A the standard discusses the relationship between an “alert” and a “notification” in public warning.  And Annex B covers public awareness, an essential component of any successful public warning system.  A 5-item bibliography completes the standard.

As noted above, ISO 22322 is a copyright document and must be purchased from an authorized ISO distributor.  Get your copies of all ISO standards from Document Center Inc. and be assured of compliance with the law.  They can be ordered online in both paper and pdf format at our Document Center Webstore, www.document-center.com.  Here’s a link directly to the order page for ISO 22322.  Or you may prefer to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can help you set up a Standards Online account to provide your organization with 24/7 online subscription access for many of the standards we sell.  Make us your Standards Experts!