New NDT Standard ASTM E543 2015 Edition

March 27th, 2015

ASTM E543, “Standard Specification for Agencies Performing Nondestructive Testing,” has just been updated and the new 2015 Edition is available now from Document Center Inc.  The standard is used to assess the competence of any public, independent or in-house NDT facility.  It was developed so that when nondestructive testing is part of the purchasing requirements, there’s a methodology for assuring the customer that the testing is done properly.

This specification covers your requirements from A to Z.  Clauses cover:

  • The organization of the “agency” (the testing facility)
  • It’s responsibilities and duties (what kind of testing it’s qualified to do)
  • Personnel requirements and Certifications
  • Requirements for a procedure manual
  • Equipment (included in mandatory Annex A1)

Appendix X1 is a chart that compares selected NDE methods (provided for your information only, not as a requirement).    This is particularly helpful since many ASTM NDT specifications are called out in the reference documents section.  This will help you choose the appropriate tests and standards.

Since this specification sets out the minimum requirements for NDT facilities, it is entirely possible to expand your requirements as necessary.  It is expected that this would be done in the purchasing contract.

If you’re using the ASTM E543, you’ll want to know what the changes are.  The committee E07 has provided you with the following information at the end of the document:  Subclauses 9.4.3 and 9.4.4 have been revised.  And of course, you’ll be needing a copy of the 2015 Edition in order to stay current with this material.

Head to the Document Center Inc. webstore at www.document-center.com to order a copy in either paper format or as a pdf download.  Want multi-user access to this ASTM publication?  Contact our staff about setting up an account for our Standards Online subscription service.  It’s an easy way to maintain your conformance documentation and offer your staff convenient access any time, any where.  You can reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Make Document Center your Standards Experts!

New ISO/TR 80001-2-7 – IEC 80001-1 Compliance for HDO’s

March 26th, 2015

ISO/TR 80001-2-7, “Application of risk management for IT-networks incorporating medical devices – Application guidance – Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1,” has just been released.  As part of the IEC 80001-2 series (also composed of some ISO 80001-2 documents), it helps you address the issue of risk within an IT network that includes medical devices.  It’s been written for organizations such as hospitals, managed care facilities, surgical centers, behavioral health care facilities, and the like.  It allows such facilities to self-assess to IEC 80001-1, “Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities.”

Does ISO/TR 80001-2-7 have any additional requirements not included in IEC 80001-1?  No, it is used to facilitate the application of IEC 80001-1 where it has been determined to be applicable.  It contains a set of questions that you can use to assess the performance from a risk perspective of your medical IT network.  And you can tailor the approach to meet your specific needs.

For example, you can use the assessment method of Clause 4 to audit your system to determine IEC 80001-1 conformance.  Or if you already know you conform, you can still use the assessment method to judge capability issues and your risk management processes.  Further, the assessment method is flexible so that it can be modified to meet the concerns of individual HDO’s.

What’s to be gained by using an internal assessment approach?  You’ll be able to spot current risk management weakness and will have a basis for improvement.  Or you might consider using it as a first-pass assessment to which you can add more stringent requirements as you move forward.

What will you find in ISO/TR 80001-2-7?  There’s guidance for the HDO self-assessment for IEC 80001-1 of course.  You’ll also get a set of questions to help you set up your assessment process for your medical IT-network from a risk management point of view.  It also will help you define a PRM (Process Reference Model) as required by IEC 80001-1.  And you’ll be able to set up a PAM (Process Assessment Model) that meets the requirements of ISO/IEC 15504-2, “Information technology — Software process assessment — Part 2: A reference model for processes and process capability.”

What are the stages of this ISO/TR 80001-2-7 assessment method?  Here are the stages that are required:

  • 1 – Defining assessment scope
  • 2 – Stakeholder involvement
  • 3 – Information collection and evaluation
  • 4 – Generating a findings report
  • 5 – Presenting the findings report

There are also a couple of additional optional stages:

  • 6 – Improvement planning
  • 7 – Follow-up assessment

There is no doubt that the reduction of risk in a patient-care setting is essential to the minimization of costs and liability, and the improvement of patient outcomes and satisfaction that are critical in today’s changing healthcare environment.  So those of you responsible for quality in an HDO setting will want to review this timely technical report now.

Where can you get your authorized copy?  Try the Document Center webstore at www.document-center.com.  You can order ISO and IEC standards in both paper format or for pdf download.  And they are available as part of our multi-user subscription service, Standards Online.  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

When you use Document Center Inc. you’ll not only get copies of the standards you need, you’ll get free update notification as well as access to other services that support your need for complete and correct compliance documentation.  Make us your Standards Experts!

New IEEE C63.7 2015 Edition

March 25th, 2015

IEEE C63.7, “American National Standard Guide for Construction of Test Sites for Performing Radiated Emission Measurements,” has just been updated.  The 2015 Edition is available now from Document Center Inc. in either paper format or for pdf download.  It can also be included in our Standards Online subscription service for multi-user access.  The EMC standard is ANSI approved (the document used to be known as ANSI C63.7).  It’s been updated so that it can be used with the latest edition of IEEE C63.4 (“American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz” 2014 Edition).

Why would you use IEEE C63.7?  The standard provides you with the requirements for building test facilities to measure radiated emissions.  The facilities will be appropriate for testing electromagnetic emissions in the frequency range of 30 MHz to 40 GHz.  It is intended to be used with the other C63 series EMC standards.

Is there only one option for this type of testing facility?  No, you have several options depending on the frequencies you’ll be testing.  For 1 GHz and below, you’ll get the requirements for an open-area test site (OATS) and a semi-anechoic chamber (SAC).  For 1 GHz and above, you can choose from an OATS with absorber material or a SAC again with absorber material, in a number of surface configurations (one of which is called a fully anechoic room (FAR)).

What are the changes in this new 2015 Edition for IEEE C63.7?  The committee has highlighted the following areas where updates have occurred:

  • OATS with weather protection coverage are now included.
  • New provisions are introduced for SACs and FARs.
  • There’s updated to grounding for radio frequency low impedance and for human safety.
  • Of course, the coverage of the document has been expanded from 1 GHz to 40 GHz.
  • Links to useful URL’s are now included.
  • Annex C has been added (it cites the occurrences of “test site” in the C63.4 and C63.5).
  • Annex D, the bibliography, has also been expanded.

How can you get a copy of IEEE C63.7?  Go to the Document Center Inc. webstore at www.document-center.com.  You’ll have a choice of ordering IEEE C63.7 (paper format) or IEEE C63.7 PDF (pdf format).  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  They can help you with any questions or provide you a quote for multi-user access.  You have a choice, so remember to use Document Center for all your standards purchases and support services.  We’re your Standards Experts!

New ISO 5356-1 4th Edition Released

March 24th, 2015

ISO 5356-1, “Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets,” has just been updated.  The new 4th Edition is available now from Document Center Inc.  It can be purchased in paper format, as a pdf download, or for inclusion in our Standards Online multi-user subscription service.  Since it is a technical revision, the 4th Edition withdraws and replaces the 3rd Edition from 2004.

ISO 5356-1 is widely used for breathing attachments in anesthetic and respiratory equipment.  This is because in clinical practice there is often more than one device or items of medical equipment making up the breathing system.  The challenge is in providing connections for all these types of equipment that are interchangeable.   So the ISO 5356 series (both Parts 1 and 2) provide the manufacturers with specifications so that equipment from more than  one source will still work easily together.

If you use this standard, you’ll want to know what the changes are in this new edition.  The ISO committee 21 has provided you with guidance in the foreword to the new edition.  Here’s the highlights:

  • The revision makes the terminology consistent throughout both the title and text,
  • Updates to the definition section,
  • 11,5 mm cones and sockets have been included,
  • Modifications to the internal diameters of some cones
  • Significant changes to the requirements of 22 mm latching sockets and cones,
  • Corrections to Annex A, and
  • Restructuring of the document in order to make the text clearer.

FYI: There are no updates pending for the ISO 5356-2 on screw-threaded weight-bearing connectors at this time.

If you use this standard, you’ll want to get a copy of this new revision.  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 the ISO standards since the 1990’s and offer a full range of services to support your use of compliance documentation.  Do like thousands of other companies do and make Document Center Inc. your Standards Experts!

ASTM D638 updated – Plastic strength test

March 23rd, 2015

ASTM D638, “Standard Test Method for Tensile Properties of Plastics,” has just been updated and the new 2014 Edition is available now at Document Center Inc.  Although the document was approved in 2014, it has just been made publicly available (published).  This is one of the most commonly used test methods for determining the strength of plastic.  It tells you how to test the strength of a plastic specimen in the shape of a dumbbell or dogbone in specific conditions, including temperature, humidity, and testing machine speed.

The test is basically executed by putting your specimen into a test machine that basically pulls the sample apart.  It’s held in place by grips and measurements are made as this process is taking place.  You then use your data to determine your results.

One thing to realize with a standard like this is that those results can vary depending on a number of factors.  So ASTM is clear in pointing out where these variations can occur and what you must do if your application requires more precise results.  The committee has also provided caveats for those who want to use the test for engineering design.

You’ll want to note that if your material is thinner than 1.0 mm (0.04 inches), you’ll need to use the ASTM D882.  And if the specimen is thicker than 14mm (.55 inches), you’ll have to reduce the thickness by machining.

Since ISO 527-1 is a similar standard, there is the question of interchangability.  The answer? They are not.   ASTM D638 and ISO 527-1 cover the same subject matter, but they are different in the technical content.  This divergence occurred when the ISO 527-1 was updated in 2012.

Now to take a look at where the changes are in this new 2014 Edition, since it cancels and replaces the previous 2010 issue.  The authoring committee, ASTM D20, has put a list of updates at the end of the document.  You’ll see that:

  • Note 1 has been revised, since ISO 527-1 is no longer equivalent (the changes that happened when the 2nd Edition of ISO 527-1 was released).
  • Updates have happened in some areas of the standard to eliminate permissive language
  • Editorial changes have also been made
  • Tables 2, 3, 4, and 5 have been moved to Section 13 (Precision and Bias)
  • And of course, the summary of changes has been changed!

If you use this standard, you’ll need to get a copy of the new D638-14!  Order online at the Document Center Inc. webstore, www.document-center.com.  You’ll have the option of ordering a paper copy or getting a pdf download.  Want multi-user access?  Check in with 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).  Document Center has been an authorized distributor of ASTM standards since the 1980’s.  You’ll notice the difference when you take a look at the revision history of the standards you’re interested in.  So make us your Standards Experts!

New update for EN 12972 – For tanks transporting dangerous goods

March 20th, 2015

EN 12972, “Tanks for transport of dangerous goods. Testing, inspection and marking of metallic tanks,” has just been updated.  The new 2015 Edition is now available and replaces the previous 2007 Edition.  While it is a European Standard, there is some contention regarding it’s ability to completely meet the actual requirements of the European Agreements Concerning the International Carriage of Dangerous Goods by Rail (RID) and by Road (ADR).

EN 12972 was developed to support the needs of the agreement for transportation via road.  The standard itself covers fixed tanks (tank vehicles), demountable tanks, rail tank wagons, portable tanks and tank containers for the transport of dangerous goods.  In it, you’ll find coverage of testing, inspection and marking for the type approval, initial inspection, periodic inspection, intermediate inspection and exceptional check of metallic tanks (shell and equipment).

However, the 2015 Edition was adopted by a vote of the member states that was deeply divided, with two states voting against the standard and a number of states abstaining.  The concern?  That during the comment period questions regarding the safety of tanks transporting gases were not adequately addressed, raising a number of concerns about materials that are explosive when exposed to water, etc.  So when you use this standard, you’ll note that there’s a disclaimer that “[i]t is essential that the requirements of the applicable regulations for the transport of dangerous goods prevail in all cases over those of this standard.”

Of course, you may ask why there’s a European standard that appears to not be able to meet the requirements of the European legislation.  I note that this is a particular problem that has been cropping up lately, as regulatory approval of standards development in the EU is less of a rubber stamp than in the past.

Of course, with all the concerns about the transportation of dangerous goods raised by recent rail accidents involving petroleum shipments, industry is looking for ways to minimize the risks associated with the transport of these materials.  It appears from the concerns raised by the U.K. and others in the EU, that there’s still a ways to go before standards will offer a methodology for assuring compliance to the realities of legal requirements in that jurisdiction.

However, if you use the standard, you’ll need a copy of the most recent update as you cannot ignore the changes that have been made to this publication.  At Document Center, you have a number of options.  Currently you can purchase the new 2015 Editions as the BS EN 12972 (British), SS EN 12972 (Swedish), and DS/EN 12972 (Danish).  The DIN EN 12972 (German) is expected to be available in April.  The technical content of each of these national adoptions is identical and all are published in English, so you can use any one of them with confidence.

Order online at our 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).  Why choose Document Center Inc.?  We have the expertise you need to purchase and maintain this type of conformance information.  We are a woman-owned small business, with a focus on standards since 1982.  And we offer personal and responsive service that you won’t find anywhere else.  Make Document Center your Standards Experts!

New ISO 2394 Edition Released

March 19th, 2015

ISO 2394, “General principles on reliability for structures,” has just been updated.  The new 4th Edition from 2015 is available now in paper format, for pdf download and as part of Standards Online multi-user subscription service, all from Document Center Inc.  The new 4th Edition replaces the 3rd Edition from 1998, which is now obsolete.  This is a technical revision.

ISO 2394 is called out in Eurocode 1, “Actions on structures.”  This makes it part of good practice when designing buildings and other civic structures.  The ISO standard has been updated to reflect advances in how decisions about load-bearing structures are made in the construction industry today.  The changes focus on risk considerations and reliability.  This means that safety and reliability requirements are now based on risk considerations and socio-economics rather than efficiency requirements of a heuristic character (rule-of-thumb.)

The implementation of this protocol means that there’s a three level approach to the problem of reliability:  1.  Risk informed, 2. Reliability based, and 3. Semi-probabilistic.  In order to help the user get up-to-speed with this approach, the committee has included informative annexes as well as references to other publications with further details.

Now down to the details of what’s actually in ISO 2394 2015.  First, there’s the usual scope and terms and definitions clauses.  Then symbols are reviewed.  Clause 4 discusses the fundamentals of structures and structural performance.  Performance modelling is then reviewed in Clause 5, while Clause 6 covers uncertainty representation and modelling.  Next the standard covers the three types of decision making:  Risk-informed, Reliability-based and the Semi-probabilistic method.  Annexes A through F cover such topics as quality management, lifetime considerations, code calibration, life safety, and so on.  A 21-item bibliography completes the standard.

The new edition is 120 pages in length and provides you with a wealth of information on this topic.  Not only is the publication well-used in Europe, it is also called out in the requirements for many other regions.  And certainly, there is no doubt that the committee strongly urges other jurisdictions to review and use this information.  It’s part of an international effort to provide more harmonization where building codes and requirements are concerned.

Where should you purchase your copy of ISO 2394?  From an authorized distributor or your national standards body.  Go to the Document Center webstore to order online 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 have been selling ISO standards under contract since the 1990’s and have the expertise to help you with your compliance documentation issues.  Make us your Standards Experts!

 

 

New CISPR 14-2 Edition 2.0 Released

March 18th, 2015

CISPR 14-2, “Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 2: Immunity – Product family standard,” has just been updated.  The new Edition 2.0 is available now from Document Center Inc. in paper format, for pdf download and as part of our Standards Online multi-user subscription service.  The document is a companion to CISPR 14-1 and deals with the uniform requirements for providing electromagnetic immunity (protection from electromagnetic disturbances from other equipment, etc.) for household appliances.  These can include your microwave oven, battery chargers, electric toys and tools, and the like.  The new Edition 2.0 replaces the old Edition 1.0 with Amendments 1 and 2, which  are now withdrawn.

What is included in the CISPR 14-2?  You’ll find the document includes test specifications for immunity, gives you references to the basic standards you’ll use for various testing methods, and standardizes operating conditions, performance criteria and how to interpret your test results.

What are the changes in this new edition of CISPR 14-2?  While there are changes throughout, the significant updates are found in the following sections:

  • Sub-Clause 5.1, for ESD tests on the contacts of plus and sockets.
  • Sub-Clauses 5.3 and 5.4, updated tables for tests at the d.c. power ports
  • Sub-Clauses 5.3 and 5.4, updates for the test set-up in Figure 2
  • Sub-Clause 5.5, introduces IEC 61000-4-2 as an alternative method for testing radiated immunity
  • Sub-Clause 5.6, updates are made to the line-to-earth requirements

The CISPR 14-2 is formatted in the usual manner.  There’s a scope, referenced documents, and terms and definitions Clauses at the start of the publication.  Then you’ll find information on the classification of “household” apparatus, the applicable tests (like ESD and surges), and performance criteria.  Clause 7 reviews the issues surrounding the applicability of immunity tests, including coverage of the various categories of apparatus.  Clause 8 is on the conditions you’ll meet when testing and Clause 9 provides you with information on the assessment of conformity.  Annex A is for your information only, and is a guide for permissible degradation.  A short bibliography completes the standard.

Of course, you’ll want to get your copies of all CISPR and IEC standards from an authorized distributor like Document Center Inc.  Order with confidence 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).  We’ve been selling standards since 1982.  Make us your Standards Experts!

New MIL-PRF-38534 J Released – Hybrid Microcircuits

March 17th, 2015

MIL-PRF-38534, “Hybrid Microcircuits, General Specification for,” has just been revised.  The new Revision J is available from Document Center Inc. in paper format, for pdf download, and as part of our multi-user Standards Online subscription service.  This document is one of the primary U.S. military publications for microcircuits and has been one of our best sellers on the topic for many years.  If you use this spec, you’ll need to comply with the changes in Revision J by September 9, 2015.

MIL-PRF-38534J was formerly called out as MIL-H-38534.  It was renumbered back in 1995 as a result of Mil Spec Reform.  The new Revision J is a total of 151 pages.  However, the main requirements account for the first 20 pages only.  The balance of the publication is a series of Appendices (A through G – but not including B which was discarded a while back) which provide the details of implementing the specification.  Since the previous Edition (Revision H) was only 139 pages, you can tell there have been some updates in this issue.  Appendix G has been completely re-written.  Other changes are marked with asterisks in the margins for your convenience.  As is usual, the document does warn you that the marking of the areas with updates are done as a convenience only and may not be complete.

As many of you know, the U.S. military is an active and major consumer of electronics.  This means that the contract requirements for microcircuits, components, and so on play an important role in the industry.  This publication gives device manufacturers the baseline requirements for the performance of not only hybrid microcircuits but also multi-chip modules (MCM) and similar devices.  You’ll use the document if you’d like to be (or want to continue to be) included as part of the QPL (Qualified Products List) program.

You’ll find information on 7 quality assurance classes (D, E, F, G, H, K and L) in MIL-PRF-38534.  There is a separate clause with the requirements for each.  There’s also a Table II with an implementation summary that you’ll find to be particularly helpful.  Designation formats for these devices is covered in depth, as is certification and marking.

Of course, the Appendices take up the bulk of the specification.  Here you’ll find guidance on your quality management program, generic performance requirements, generic design and construction criteria, and so on.  The interactive index at the end of the publication is still part of the document.

Now you’ll want to get a copy.  Consider purchasing your military specifications from Document Center Inc.  Why?  Our prices are lower than the other standards resellers.  You’ll get our superior notification service free with the purchase of all standards from Document Center.  This means that you won’t be caught without the latest edition of the document!  And we’ve been working with these specs and standards since 1982, so we understand how they are used.

You can order online 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).  We’re a woman-owned small business, with a focus on standards and standards products to help you control and maintain your compliance information.  Make us your Standards Experts!

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!