Amendments update ISO 11607 series

July 28th, 2014

The ISO 11607 series, “Packaging for Terminally Sterilized Medical Devices,” has just been updated with the release of amendments for each of the 2 parts.  You’ll need the new updates in order to keep your copies of the standards current.  Let’s review each amendment separately:

ISO 11607-1, 1st Edition, AMENDMENT 1, Part 1: Requirements for materials, sterile barrier systems and packaging systems, Packaging for terminally sterilized medical devices

This is the lengthier amendment, a total of sixteen pages in all.  It includes two pages of pen and ink changes that you’ll need to make to your original copy of the 2006 edition.  Next the list of test methods given in Annex B Clause 2 (B.2) is replaced by a brand new Table B.1, Test Methods and Their Status.  This new table is seven and a half pages in length!  Lastly, extensive changes are made to the bibliography.   This new amendment will keep you busy making changes and analyzing the impact.

ISO 11607-2, 1st Edition, AMENDMENT 1, Part 2: Validation requirements for forming, sealing and assembly processes, Packaging for terminally sterilized medical devices

This amendment is going to be a little easier for those of you using the document.  It primarily focuses on updating the bibliography.  This means you’ll be reviewing your referenced documentation to make sure you’re using the correct editions of a number of standards.  And you’ll also want to pay attention to the changes that have been made to the language in Clauses 4.1.3 and 5.3.2.

Of course Document Center customers have already received their notifications about the new amendments.   If you’d like this type of timely updating and convenient ordering, you can purchase your copies of the new releases at our webstore, www.document-center.com.  Or you may prefer to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Authorized copies of ISO standards are available in paper format, for pdf download, and as part of custom online access subscriptions.

Document Center Inc. has been a distributor of ISO standards since the 1990′s.  We’ve helped thousands of customers just like you with maintaining and understanding conformance documentation collections.  Make us your Standards Experts too!

New ISO 16678 for detecting counterfeits

July 25th, 2014

Identifying and removing counterfeit and fraudulent components and goods from the supply chain is a top priority of a wide variety of organizations.  The use of inspectors and automated systems is one response to the problem.  However, since the issue is global in scope, co-ordination at the highest levels is required.  So the publication of ISO 16678, “Guidelines for interoperable object identification and related authentication systems to deter counterfeiting and illicit trade,” is a welcome development.  It provides guidance on the principles for developing effective identification and authentication systems.

There are six major sections in this new release:

  • The scope confirms that this is a guidance document and contains no requirements.
  • Next the usual definitions section is presented, to help you understand the context of the various terms.
  • An overview provides you with the details of how object information systems can be used to detect counterfeits.
  • A key principles section covers the concepts and values behind the development of this standard.
  • Then recommendations for improving the interoperability of systems used to provide object information to inspectors are covered.
  • Lastly, three informative Annexes cover digital certification (for inspectors), master data management and examples of implementation.

The bibliography at the end of the standard provides you with 22 additional resources, referencing both standards and other publications.

The goal of this new issue?  To improve the trustworthiness of the logistics system that supports the movement of authenticated goods around the world.  The desired result?  Greater detection and deterrence of fraud.  The challenge?  To create a system that identifies “spoofing,” or the attempt to counterfeit the identification system itself!

If you’re involved in logistics and want to understand how to implement information systems to improve your ability to reduce the introduction of counterfeit parts into your supply chain, the ISO 16678 is for you.  You can get your copy in either paper format or for pdf download at the Document Center Inc. webstore, www.document-center.com.  Or feel free to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been supplying standards to our customers since 1982.  Make us your Standards Experts!

New EN 16495 – Air Traffic Management

July 24th, 2014

Air traffic safety has been at the center of our attention for much of this year.  And one important aspect of air safety is the use of computerized management systems for control and navigation.  Now the European Union has issued a new standard on this subject, EN 16495.  It’s titled “Air Traffic Management. Information security for organizations supporting civil aviation operations.”  And it addresses one of the emerging issues in all highly automated systems — Security.

This new European Standard was issued to provide users with guidance and general principles for implementing an information security management system.  It can be used by any organization that supports civil aviation operations, particularly in Europe.  Of course, this excludes such aspects of air travel as the retail outlets and service facilities at airports and so on.

It is becoming increasingly clear that air traffic management is a critical responsibility of a network of players in this space.  So the new standard is useful for airlines and other air carriers, airports, and navigation service providers.  Since a security failure can negatively impact the entire system, it’s essential to develop security systems that can work throughout the aviation chain.  Certainly, the Europeans are working towards increased cooperation and trust for improved management of air traffic.

If you need a copy of this new EN Standard, you have a couple of options.  You can purchase the BS EN 16495 Edition in paper format.  Or you can buy the DIN EN 16495 Edition in paper format or for pdf download.  Both copies have identical legal status, so it’s up to you which edition you prefer.  Just go to the Document Center webstore at www.document-center.com.  You’ll be able to search for and order from a catalog of over 450,000 unique titles.

One thing you won’t be able to do is get the EN 16495 document without purchasing one of the national reprints.  Even though the EN document will appear in our database, it is not actually for sale.  You do have to choose from one of the national publications in order to make your purchase.  If there’s any questions, just get in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to help you with any questions you might have.

Document Center Inc. has been providing folks like you with standards since 1982.  Make us your Standards Experts!

New ASTM A370 2014 Edition – Testing Steel Products

July 23rd, 2014

The ASTM A370, “Standard Test Methods and Definitions for Mechanical Testing of Steel Products,” has just been revised and the new 2014 Edition is available from Document Center Inc.  The 50-page test method standard covers testing of steel, stainless steel and related alloys.  You’ll use these tests to determine the properties required by your product specifications.

Mechanical tests cover tension, bend, hardness, and impact.  An additional 10 Annexes cover bar products, tubular products, fasteners, round wire products, notched-bar impact tests, conversion of percentage elongation for round specimens to flat ones, multi-wire strands, rounding your test data, steel reinforcing bars, and heat-cycle simulation.

The last revision of this document was released in 2013.  Changes from this previous (now obsolete) edition are found in the revised section 19.1, additional information in Note 7, revisions to the hardness test location in annex A3.3.1, and a correction to Table A5.1.  You’ll find the detailed information on page 50 of the new release.

You have several purchasing options that can be of benefit to your organization.  Certainly, when ASTM standards are revised (not reaffirmed), redline editions are made available.  This service provides you with a clean copy of the new edition and a “marked-up” copy of the previous one.  This means that it’s easy to review the two documents and spot the changes.

Another option for Document Center customers is the inclusion of ASTM standards in our Standards Online subscription service.  For the user of the ASTM A370, for example, Standards Online allows for access to the standard by employees of your organization from 1 or more facilities.  And updates during the subscription period (it’s an annual service) are included at no additional charge.  Since the ASTM A370 has historically been updated at least once a year since 2001, this will provide you with additional flexibility and compliance.

To purchase your copy, go to Document Center’s webstore at www.document-center.com.  You’ll be able to purchase the document in paper format or for pdf download.  If you’d like the redline edition, please include your request in the notes field in the ordering process.  If you’re interested in our Standards Online subscription access, just contact our sales staff.  They’re available 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.  Make us your Standards Experts!

UL 94 6th Edition updated – Plastic Parts Flammability

July 22nd, 2014

You’ve got your copy of the new UL 94 6th Edition, “Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances.”  Now you’ve gotten our notification regarding the new Change Notice from 7/11/2014.  What’s the change notice?  How does it affect your copy of the UL standard?

Good questions!  When UL standards are updated, they can either be re-written altogether and released as new editions, or have change notices issued.  Right now, the new change notice for the UL 94 does two things.  First, it alerts you to the fact that the standard has been ANSI approved.  This means that the title page has been reprinted with the information on the ANSI adoption (it took place 7/9/2014).  Then, there’s been technical changes to the standard as well.

The technical changes in this particular notice were made for the relative humidity tolerance for sample conditioning.  This affects two sections of the standard – Section 5 (Paragraph 5.10) and Section 6 (Paragraph 6.1).  To make it easier for you to identify these changes, lines have been placed in the margins of the updated pages in the change notice.

One thing to remember is that when you purchase any UL standard, your copy will include all change notices up to the date of your purchase.  However, you will have to buy any notices or new revisions that are released after that date.

So if you use this UL standard, you’ll need to purchase the change notices as they are released in order to stay current with the document.  You can take care of this at the Document Center webstore, www.document-center.com.  Or you can contact the Document Center staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Not only will you get the document, you’ll also get our best-in-class notification service for no additional cost.  This means that you’ll get an email each time your standards are updated.

Remember, Document Center has been selling standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

MIL-STD-883 J on Microcircuits updated again!

July 21st, 2014

It seems like only yesterday that I blogged about the new MIL-STD-883 J with Change Notice 3 on Microcircuit Testing…  Actually it was on June 30th!  (Here’s the link to my review of MIL-STD-883J with Notice 3.)  And now there’s already a new MIL-STD-883 J with Change Notice 4!

Since I’ve reviewed the document a number of times, I won’t go over the basics of this test method standard.  But I know you’d like to learn what’s behind this rapid release of another update.  It turns out that in Test Method 2010, an error was inadvertently inserted into paragraph 3.1.1.1h.  This revision corrects that error.

You may ask how you’re going to keep up with these types of changes.  They’re hard to track and harder to disseminate throughout your organization.  Well, Document Center has a solution for that!  Our new Standards Online subscription access service may be the answer you’re looking for.  Standards Online allows authorized access to the standards you use for multiple folks in your company.  It’s a yearly subscription to online access for your custom collection of standards.

Let’s use MIL-STD-883 as an example of the benefits of the Standards Online service.  If it was part of your collection, the new edition would have automatically been posted to your Standards Online collection when it was released.  This means that your staff would have automatically been able to use the latest edition without you having to worry about it!  And because this service provides online access, you can easily use your standards 24/7 where ever you happen to be!

If you need online access to a specific standards collection across your organization — 24/7, let Document Center help you out!  We’ve been providing standards to folks like you since 1982 and have the expertise to insure your compliance documents are in tip-top shape.  Get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  And you can always search for and order any standard you need at our webstore, www.document-center.com.  Make us your Standards Experts!

New ASTM E2962 – Guide for Fleet Management

July 18th, 2014

You’ve got a fleet of vehicles at your company, and you want to make sure that you’ve got all your bases covered when it comes to managing and maintaining that fleet.  Or you’re setting up a new product line and since it includes delivery, now you’ve got to manage a fleet of company delivery vans.  Whether your organization has a fleet of motor vehicles, airplanes, boats, or other specialized vehicles, the new ASTM E2962 gives you the guidance you need.

Titled “Standard Guide for Fleet Management,” this new document covers the abc’s of fleet management.  You’ll get information on how to maximize the value of the fleet to your organization while minimizing the risks associated with this type of asset.  It helps you set up the kind of performance measures that help you achieve cost savings, increased asset utilization, longer asset life, and improved mission effectiveness.

All phases of asset management are covered, from fleet purchases to vehicle disposal.  Not only that, but consideration is given to the degree of expertise required of the personnel that will be operating the fleet.  It will certainly help you review the issues that will impact the training program you develop for your staff.

You’ll be setting up your own policies, procedures, record keeping, and other systems to manage your asset.  But you’ll use the ASTM E2962 as a guide for what to include and how to implement your process.  Only good planning and viable systems can minimize the risk associated with the operation of fleets of vehicles.  Count on ASTM to have a basic guide that gives you a complete review of the considerations you need to take into account.

When you’re ready to get your copy, head to Document Center’s webstore at www.document-center.com.  You’ll be able to get your authorized copy of any current (and many obsolete) ASTM standard in either paper format or for pdf download.  When you standard changes, you’ll get a notification.  Or you can always log into our site and review the status of your standards at any time.

Document Center Inc. has been providing standards and other compliance information to companies like yours since 1982.  Make us your Standards Experts!

New IEC 60065 8th Edition – Safety for Audio & Video Equipment

July 17th, 2014

IEC 60065 (formerly IEC 65) is the basis for safety for all types of audio and video equipment.  Now there’s a new 344-page 8th Edition, and it’s available from Document Center Inc. in both paper format and for pdf download.  Titled “Audio, video and similar electronic apparatus – Safety requirements,” it cancels and replaces the 7th Edition from 2001 (as well as the Amendments 1 and 2 for that revision).

What types of equipment is covered by this standard?  It’s used for electronic musical instruments and accessories, video projectors and other types of A/V equipment, video cameras, games, tape recorders, CB (Citizen’s Band) equipment and so on.

What’s the purpose of the IEC 60065?  To provide protection to the people using such equipment, as well as to the equipment’s surroundings.  This is accomplished by providing information on both the included requirements as well as the essential principles supporting those requirements.  Basic protection from such hazards as electric shock, radiation, heat, fire and various burns are the result of adherence to the standard.  You’ll also get such basic information as marking and instructions.

What are the changes in this new 8th Edition?  Here’s a quick list:

  • New requirements for wall and ceiling mountings
  • New requirements for batteries (coin/button cell)
  • Revision of the notes fields to meet requirements from new directives
  • New requirements for LEDs
  • Creepage distances are brought into line with those of IEC 60950-1
  • Optocoupler requirements have been changed

How can you get a copy of this new update?  Go to the Document Center Inc. webstore at www.document-center.com.  Or if you prefer, you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You can purchase standards and other regulatory material here and get automatic notifications when any item you’ve purchased changes.  And we have additional services available to assist you with the chore of maintaining your standards collection.  We’ve been providing standards to our customers since 1982.  Make us your Standards Experts!

New AWS D1.2/D1.2m Structural Welding Code – Aluminum

July 16th, 2014

AWS D1.2/D1.2M, “Structural Welding Code – Aluminum,” has just been revised and you can get your copy from Document Center Inc. now!  Formerly known as AWS D1.2, this new 2014 Edition is the first update of the Code since 2008.  It provides the user with a set of rules for welding structural aluminum.

Who should use this Code?  It has been developed for the fabrication, erection and manufacturing industries.  And it’s often called out in both contracts and in building codes as well.

What’s new in this 6th edition?  Good news.  All changes are marked with either underlines or lines in the margins.  Here’s information on the major revisions:

  • The addition of responsibilities for the engineer, contractor and inspector
  • The deletion of Class I and Class II structure types
  • Removal of aluminum alloy 5652 (deactivated by the Aluminum Association)
  • The change from conventional to pulsed power supply is not an essential variable for qualification
  • GTAW current type (AC or DC) is now an essential variable.
  • A change in the shielding gas doesn’t mean welder requalification
  • Preparation of base metal requirements were revised
  • ASTM B928 base metal alloys 5083, 5086 and 5456 were added
  • You’ll need to RT or UT CJP groove welds entirely when welded from 1 side where it’s inaccessible for visual inspection
  • No more torque test for qualifying stud weld WPSs
  • Only 5xxx studs remain, all others have been deleted
  • Changes were made to the minimum tensile strengths for studs
  • Friction stir welding has been added
  • Revision has been made to the minimum size of reinforcing fillet welds in corner and tee joints
  • Annex E on Effective Throat was deleted
  • Changes have been made to Annex J

This is an extensive update, totalling 232 pages in all.  You’ll want to get your copy as soon as possible.  So order it 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 providing standards to our customers since 1982.  Make us your Standards Experts!

The draft for ISO 14001 3rd Edition is available for comment

July 15th, 2014

You have an environmental management system in place, which means you’re audited to assure compliance.  And you’re aware that the ISO management system standards are being reviewed to provide better continuity between the various systems, making compliance easier.    But are you aware that you can review the proposed 3rd edition for ISO 14001, “Environmental management systems – Requirements with guidance for use,” and comment on the document if you have concerns?  This draft, ISO/DIS 14001, is now available from Document Center Inc. in either paper format or for pdf download.  It’s your chance to see what changes are in store before they’re finalized.

Right off the top, you’ll notice the new layout of the information in the standard.  Instead of the previous 4 clauses, the proposed edition has 10.  Why?  To better follow the new structure of all the management system standards.

In the current 2nd edition from 2004, there are the usual scope, referenced documents, and terms and definition clauses.  Then all the environmental management system requirements are included in the comprehensive clause 4.  In the draft, the clauses following the similar first 3 clauses are:

  • Context of the organization (Clause 4)
  • Leadership (Clause 5)
  • Planning (Clause 6)
  • Support (Clause 7)
  • Operation (Clause 8)
  • Performance evaluation (Clause 9)
  • Improvement (Clause 10)

Annex A remains the guidance on the use of the standard.  Annex B provides you with a comparison of the draft 3rd Edition and the 2nd Edition from 2004.  It has 2 sections, the draft to the standard and the standard to the draft.  Since it includes the paragraph numbering for each, it’s very clear how the information from the 2nd Edition is going to be found in the 3rd.  Lastly, Annex C is an alphabetical index of the terms from clause 3 (terms and definitions section).

It’s not mandatory to get a copy of a draft document.  However, many of our customers do like to know in advance how the document is likely to change.  And it also offers them a chance to affect the content of the new revision if they choose to.  In the case of the ISO/DIS 14001, the public comment period is from 8/28/2014 to 11/28/2014.  If all goes smoothly, the new 3rd edition will probably be released in late 2015.  If there’s issues that are uncovered, well, you just don’t know!

One more thing to mention.  Since this is a public review draft, every part of the document is subject to change.  So don’t decide to change your system based on a public review draft!  It’s only being offered up by the committee to see if there’s any areas where the document needs review or revision.

If you want a copy, you can purchase one from Document Center’s webstore at www.document-center.com.  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Not only will you get your copy of the draft, but when the final authorized new edition is released, we’ll let you know!  So take the guesswork out of your standards program.  Make Document Center your Standards Experts!