New ISO 1101 2017 – Geometrical Product Specifications

ISO 1101, Geometrical product specifications (GPS) – Geometrical tolerancing – Tolerances of form, orientation, location and run-out, has just been updated.  The new 2017 Edition is available from Document Center Inc. now.  It is an important part of the ISO GPS Masterplan from ISO 14638.  As noted in the title, it is the geometrical tolerancing standard for form, orientation, location and run-out (chain of standards links A, B and C).

This document provides you with a symbol language you’ll use when specifying ‘workpieces’ geometrically.    You may think of these as technical drawings.  The symbols can be used for both 2D and 3D representations.  In many ways, the document, and the family of standards it is part of, are very much like the ASME Y14 series of standards.

The new 2017 4th Edition of ISO 1101 replaces the 3rd Edition from 2012.  It is a technical update and has changes in critical parts of the standard.  For example, there have been a number of tools added.  These are for:

  • filtering of the toleranced feature and a line type
  • tolerance associated features
  •  specifying form characteristics
  • specifying the constraints to the tolerance zone

Additional changes include:

  • clarification of rules regarding the use of ‘all around’ or ‘all over’ modifiers
  • tolerance zone directions in some specific cases
  • the introduction of a ‘between’ symbol to replace the now-obsolete ‘from-to’ one.

Other change occur throughout the publication.

Document Center Inc. is an authorized distributor of all ISO standards.  You can search for and order them at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 1101.  You will be able to purchase it online in either paper format or for pdf download.  Other options are available.

To learn more about company-wide cloud access, check in with our staff.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We also have a wide range of products and services to help you choose and maintain your compliance documentation.  We’ve been selling standards since 1982.  Make us your Standards Experts!

 

ISO/IEC 30122-2 Voice Commands Standard

ISO/IEC 30122-2, Information technology – User interfaces – Voice commands – Part 2: Constructing and testing, has just been released.  The ISO/IEC 30122 series focuses on the principle voice commands commonly used with various information and communication technology (ICT) devices.  The new Part 2 adds technical criteria and test methods for voice commands and speech recognition.

With the rapid adoption of speech recognition technologies, the need for standardization is being felt.  Definitions are required and a database of commands is being set up for use with web applications.  Parts 1 and 4 of the ISO/IEC 30122 series were published last year.  They cover the general information and database registration respectively.

However, there are a number of technical details that needed to be addressed in a separate publication.  For this, the Part 2 has been released.  What are the technical criteria for speech recognition?  And how do you test for them?  The ISO/IEC 30122-2 has these requirements for you.

First, voice commands and the speech recognition engine have to work together.  So your criteria include phonetic requirements for the words and phrases that make up your verbal commands.  Then you’ll need to test to confirm that the engine actually is correctly identifying the commands.

Requirements and recommendations are found in Section 5.  The methods of testing for conformance are also included in this section.  Information is provided on the sentence recognition ratio to help you quantify your testing results.  A 15-item bibliography completes the publication.

The ISO/IEC 30122 series will be composed of 4 parts when complete.  Parts 1, 2, and 4 are now released.  Only the Part 3 on translation and localization remains in committee.  It looks to be finished up and published at the end of this year.

To purchase your copy of the standard, use Document Center Inc.  We’re an authorized distributor for both ISO and IEC.  You can search for and order standards from many organizations at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO/IEC 30122-2 for your convenience.

You may prefer to get your standards as part of our Standards Online cloud access service.  For more information about that, please get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We would also be happy to help you with any standards questions you may have.  And we do have a broad range of services to support the collection and maintenance of compliance documentation.  Make us your Standards Experts!

EN 868-2 2017 is here – MedDev Sterilized Packaging

EN 868-2, Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods, has just been updated.  The new 2017 Edition is available now from Document Center Inc.  It must be adopted by all European Union countries by August 2017.  It replaces the EN 868-2 from 2009.

Medical device sterilization is an important safety requirement.  But with the many jurisdictions providing regulatory guidance on this issue, harmonization of requirements often times feels elusive.  So those of you using this document will be pleased to know that a major part of the update involves aligning it with the EN ISO 11607 series.

Other modifications have been listed in the Annex A.  While not an exhaustive list, it gives you a good idea of where the changes are.  It also relates the changes to other EN ISO and EN standards which cover similar requirements or provide needed tests.  Some improvements to the standard have also been made for repeatability and reproducibility.  Annex B has been deleted.  The bibliography has been expanded.

While EN 868-2 is related to the Medical Device Directive (93/42/eec), it has not been formally adopted as a harmonized standard.  So you will not find it on the harmonized list nor will the notice of adoption appear in the Official Journal.  This means that there is no legal implementation date for you with regards to the EU.

You’ll have a number of purchasing choices for this standard, as is the case with all EN publications.  Check our website, www.document-center.com, to see which may be best for your purposes.  Here is a link to a search page which displays 5 options for you.

Still have questions?  Just get in touch with us here at Document Center Inc.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  Our knowledgeable staff is available to you for any standards questions you may have.  We also have a number of products and services that will help you manage your standards collection more effectively.  Make us your Standards Experts!

 

Incorporation by Reference (IBR) News

The issue of Incorporation by Reference (IBR) of standards into the U.S. Code of Federal Regulations (CFRs) has generated a number of copyright issues.  Now with a recent ruling by the U.S. District Court for the District of Columbia, some clarity has been offered.

At issue is the very concept of copyright for standards documents referenced in U.S. regulations.  There has been an on-going debate about copyright in these instances.  Should IBR standards be freely available or should the rights of the copyright holder (the standards developer) be upheld?

On one side of this debate stands an organization called Public.Resource.org, Inc. which has been posting IBR standards on the Internet.  Challenging the “freely available standards” stance, ASTM International, ASHRAE (the American Society of Heating, Refrigerating and Air-Conditioning Engineers) and NFPA (the National Fire Protection Association Inc.) are on the other.  The battleground was a lawsuit brought by these Standards Developers (SDOs) against Public Resource for posting standards without permission and without compensation.

Last week, the court ruled in favor of the SDOs.  This means that IBR does not move referenced standards into the public domain.  Copyright protection continues to be in force.  This may mean free “read-only” access or it may mean the standards need to be purchased.  Each SDO continues to be the decision maker with regards to distribution.

Why is this considered a victory by SDOs?  Sale of publications in many cases is a significant part of the funding for these non-profit organizations.  IBR standards can be some of the most frequently used documents in their catalogs.  The potential lost revenue represents a legitimate challenge to the way standardization is funded.  As ANSI (the American National Standards Institute) notes, “The ruling supports ANSI members and the standards ecosystem, and enables the plaintiffs to continue to develop high-quality voluntary consensus standards that support federal, state, and local agencies.”

The standards community as a whole is grateful to these three associations for taking on the legal challenge presented by Public Resource and others of its kind.  Copyright protection requires constant vigilance.  However, many associations do not have the funds available to take on such a case.  Leadership by ASTM, ASHRAE and NFPA has been a boon to the community as a whole.

Standards are included in our regulations as best-practice solutions for health, safety, and quality requirements.  Having the two systems work in harmony is essential — one being the voluntary standards system and the other the regulatory framework for the enforcement of our laws.  I expect this ruling to provide the legal precedence needed for creating a stable legal footing regarding copyright and IBR for the standards developing community.

IPC 7711 & 7721 Updated for electronic assemblies

IPC 7711 & 7721, Rework, Modification and Repair of Electronic Assemblies, has been updated.  The new Revision C is available from Document Center Inc. now in a variety of formats.  It is used by companies that repair, supply materials for and rework electronic assemblies.  You’ll use this standard for the procedures for reworking, modifying, and repairing these products.

The new IPC 7711 & 7721 Revision C contains the latest best practices for the industry.  Common procedures and general information on the topic are provided.  The new edition contains a number of important changes.  IPC highlights the following updates:

  • Change procedures incorporated to the main document
  • Additional BGA – CSP Removal Procedure
  • Additional BGA – CSP Installation Procedure
  • Graphics Updated
  • Individual procedures controlled by review date

Document Center Inc. has been selling the IPC standards for many years.  The IPC 7711 & 7721 is one of our consistent best sellers in the IPC publication collection.  Why?  Companies that do any repair or rework of electronic assemblies rely on this standard for maintaining their good workmanship requirements.

If you need a copy of this new issue, it’s available at our webstore www.document-center.com in a number of formats.  To take a look and choose what’s going to work best for you, here is the results page for IPC 7711 & 7721.  Please remember that all electronic formats (Pdf delivery and CD Rom format) are non-printing.  If you need a printed copy, you’ll need to purchase the standard in paper format.

You may have more questions about this document.  Or you may want to know more about the many other products and services we offer to standards users like yourself.  Get in touch with our knowledgeable staff by phone (650-591-7600) or email (info@document-center.com) for the assistance you need.  We have been selling standards since 1982 and make a point of educating our staff on the nuances of this type of compliance information.  Make us your Standards Experts!

New AMS-STD-595 Revision A – Color Standard Updated!

AMS-STD-595, Colors Used in Government Procurement, has just been revised.  The new Revision A is available from Document Center Inc. now.  I do want you to realize that the updated document is the text of the old FED-STD-595 only.  The color chips that used to come with the document now must be purchased separately.

FYI:  I blogged about the AMS-STD-595 when it was first released in 2015.  There were a few issues with the migration of the FED-STD-595 to the AMS-STD-595 at that time.  Those issues have now been resolved.

Of course, this publication is required for many U.S. government contracts.  It provides information on color identification, matching, and quality control.  You’ll also find designation and use of color media data here.  While the formulations in the standard are acceptable to some, many of our customers rely on the color chips for color matching.

So its notable that with the release of AMS-STD-595 A, there are an additional 42 new color chips.  If you would like a list of these new chips, please send us an email with your request (info@document-center.com).  Thanks!

Updates have been made to the AMS-STD-595 document as well.  Color reference media information has been updated.  The tristimulus color values have been replaced by CIE L*a*b* color values.  So this is a significant technical update from the previous edition, which is now obsolete.

AMS-STD-595, as the replacement document for the FED-STD-595, is widely used throughout industry.  As noted before, it is required for many government contracts.  But it is also widely referenced in many other applications as well.

If you’re using this publication, you’ll need a copy of the new update.  Search for and order all SAE Standards including all AMS documents from our webstore, www.document-center.com.  Here are direct links to the order page for the AMS-STD-595 A, for the order page for the AMS-STD-595 fandeck and the order page for the AMS-STD-595 complete set.  FYI: We would expect any chip orders to only ship when the new chips are available.

If you have any additional questions or would like more information on Document Center Inc., our products and services, please get in touch with our staff.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We’ve been an authorized distributor of SAE standards since the 1980’s.  Make us your Standards Experts!

New ASME B31.3 2016 Process Piping

ASME B31.3, Process Piping, has just been updated.  The new 2016 Edition is available now from Document Center Inc.  There are significant changes to this new revision from the prior 2014 Edition (which is now obsolete).  ASME has asked us to let you know about them.

First, what is ASME B31.3?  This is the code for the materials and components, design, fabrication, assembly, erection, examination, inspection, and testing of piping.  What kind of piping?  The document covers piping used in petroleum refineries; chemical, pharmaceutical, textile, paper, semiconductor, and cryogenic plants; and related processing plants and terminals.

Are you currently using the 2014 Edition, or perhaps an even earlier release?  Why should you migrate to the ASME B31.3 2016?  Here’s a list of key changes directly from ASME:

  • Severe Cyclic Conditions
  • MPa Allowable Stresses
  • Expansion Joints
  • Flange Joint Assembly
  • Ultrasonic Examination Acceptance Criteria
  • Category M Fluid Service Examination
  • Leak Testing of Instrument Connections
  • Leak Testing of Vacuum Systems
  • Leak Testing of Insulated Systems
  • Leak Testing of Assembled Piping

Piping is under more scrutiny than ever.  You’ll want to make sure that piping used in your facilities and projects meets the best practices defined in the ASME B31.3.  And you’ll need a copy of the recently released 2016 Edition to have the most up-to-date information possible.

Use Document Center Inc. for your purchases of ASME standards.  We have been working with ASME since the 1980’s.  Our catalog has an extensive list of current and obsolete ASME standards for you to order.  Find them at www.document-center.com.  Here’s a direct link to the order page for ASME B31.3 for your convenience.

Of course, if you’re using codes and standards, you need help managing your collection.  Document Center Inc. has an extensive list of products and services aimed at helping you meet your compliance requirements.  Find out more by contacting us by phone (650-591-7600) or email (info@document-center.com).  We provide our customers with more than publications.  We offer reporting, notifications, and a broad spectrum of access options.  Make us your Standards Experts!

IPC-A-620 Revision C is Here!

IPC-A-620, Requirements and Acceptance for Cable and Wire Harness Assemblies, has just been revised.  The new Revision C was released this month and is available now from Document Center Inc. in a variety of formats.  Please remember that all electronic products from IPC (both pdf delivery and CD Rom Editions) are non-printing.  So if you like that hardcopy format, you’ll need to order a paper copy.

As noted in my previous blog on IPC-A-620 Revision B, the document is a joint publication of IPC and WHMA, the Wire Harness Manufacturers Association.  So you’ll also see it referenced by it’s full number, IPC/WHMA-A-620.  It is the only industry-developed standard on the topic.  It includes information on the materials, methods, tests and acceptance criteria for wiring harnesses.  This covers crimped, mechanically secured and soldered interconnections and assembly activities for cable and harness assemblies.

Those of you already using the standard will want to know what the changes are.  IPC notes that new sections have been developed for safety wiring, safety cable, grommets, and raceways.  Additionally, other changes occur throughout the publication.

As with many of the IPC standards, there are a wealth of illustrations and photographs.  This makes the document particularly helpful.  It is frequently referenced and is one of the essential standards for the industry.  It is certainly one of our top-sellers here at Document Center Inc.

You’ll order your copy in the format you need by heading to the Document Center Inc. website, www.document-center.com.  As an authorized distributor of the IPC standards, Document Center Inc. has all IPC standards available for you.  Here is a list of the purchasing options for IPC-A-620 available at our store.

More questions? Need information about the various formats for IPC standards? Just check in with our staff by phone (650-591-7600) or email (info@document-center.com).  You’ll find us to be very helpful with standards-related issues.  You can also find out more about the various support services we offer for your compliance requirements.  We’ve been selling standards since 1982.  Make us your Standards Experts!

EN ISO 13485 2016 Corrigendum

EN ISO 13485, Medical devices. Quality management systems. Requirements for regulatory purposes, has been reissued with a second correction, Corrigendum 2.  This correction sheet has been issued by CEN, the European standards body.  The correction is dated in December 2016.

The ISO 13485 and it’s European adoption EN ISO 13485 are the main quality documents for the medical device industry.  Of course, the parallel editions do cause users some confusion — Which copy should they be conforming to?  Let’s put it this way.  If your products will be certified for use and sale in Europe, get the EN ISO edition.  Any national publication will do.

Now to address the issue of the new corrigendum.  This new issue contains corrections to the European foreword, and to the 3 Annexes (ZA, ZB and ZC).  So the technical content is identical.  Only the administrative information has been updated.

Let’s take a look at what’s going on.  The Foreword’s update adds only the supersession information for the CEN ISO/TR 14969, which is now replaced by the EN ISO 13485.  Most of the changes occur in the Annexes.

Each Annex has introductory material.  New paragraphs have been added to each.  This information helps you understand the relationship of the standard to the Directive in general.  It also defines the adoption path for the standard by the European Union.  It is meant to clarify the legal requirements for conformity, either by using the standard or presenting a compelling case for compliance without the standard.   It also explains how the Annex shows you the clauses of the Directive that can be met by the use of specific clauses within the standard.

The next change in each Annex is the inclusion of additional clause references in the second column of tables 1 and 2.  So the scope of conformance will be expanded when this revision is officially adoption by publication in the Official Journal.

For those of you who have already purchased your copy of the EN ISO 13485 from Document Center Inc., the corrected copy is available for a nominal charge.  Please get in touch with us by phone (650-591-7600) or email (info@document-center.com) to place your order.  If you haven’t purchased the standard from us, now might be a good time to take advantage of the many services we offer.

To get started, use our webstore www.document-center.com to search for and order the standards you need.  Feel free to ask us about the many additional services we offer to help you keep your standards collection complete and correct.  And we have a range of delivery options as well, including company-wide portal services.

Document Center Inc. has been working with standards since 1982.  Make us your Standards Experts!

Change to EN ISO 10993-1

EN ISO 10993-1, Biological evaluation of medical devices. Evaluation and testing within a risk management process, has been released with a correction.  The error was introduced in 2010 when the document was released with Corrigendums 2 and 3.  This new corrected edition (with Corrigendum 4) solves the problem.

The correction is a missing word in table A.1.  The word was present in the original release of the standard, but omitted in the 2010 update.  Someone must have finally spotted it, as this edition reinserts the word!  It just goes to show you that when you are working with a standard and a minor revision is issued, you will likely focus on the correction and not review the balance of the publication.  It has taken 6 1/2 years for someone to notice…

However, standards developers must insist on complete and correct information.  So if you use the EN ISO 10993-1, you will need a copy of this corrected release.  Good news for you if you purchased your copy of the standard from Document Center Inc.  You will be able to get the update for a nominal service charge.  Just let us know you need it.  We will confirm that you purchased the original 2009 Edition from us and send you off your corrected copy.

Two things to note:  Many other standards distributors do not notify you when these types of minor corrections occur.  If you want to have complete notification services from your vendor, then purchase your standards from Document Center Inc.  We have been selling standards since 1982 and understand the challenges you face when working with compliance documents.

We have a full range of options for you, including reporting, notification, and access services.  We can tailor a standards solution to meet the needs of your organization.  Contact our staff by phone (650-591-7600) or email (info@document-center.com) for more information.  Or browse our catalog of over 1 million documents.  You can find them by number or by topic at www.document-center.com.

When it comes to compliance, having a standards partner you can rely on is essential.  Make us your Standards Experts!