What makes a Harmonized Standard?

January 16th, 2015

I recently had a customer ask me, “What makes a Harmonized Standard?”  The customer was referring to the EN Harmonized Standards and wondered if all EN publications are harmonized.  As is often the case, this is actually a technical question and it depends very much on the process of standardization followed in the European Union.

Of course, there is a simple answer.  A European Harmonized Standard is mandated by the European Commission.  Once developed it must be adopted legislatively according to specific rules.  It then allows for the presumption of conformity, that is, by using a specific harmonized standard your product is presumed to comply with the requirements of a specific directive.

However, knowing how EN standards are developed is helpful here.  And the primary issue is actually the difference between standards for commerce and standards for legislated health and safety concerns.

Since EN Standards started out as a tool for creating a common market in Europe, there are many different paths a document can take in order to become a European Norm (standard).  The first big push for standardization at the European regional level was started in order to remove national differences in a wide variety of publications.  This involved national standards bodies putting forward various national standards for regional acceptance.  And the politics of adoption were challenging.

Now, with the first wave of standardization behind them, the European standards bodies develop standards for industry, consumer, and other market-driven needs.  But there is another function of standardization:  Supporting legal and regulatory requirements.

This is where the harmonized (or harmonised) system has come into being.  As various directives have been issued in the European sector, companies want to know how to meet the requirements of these legal mandates.  Standards are the perfect tool, but there needs to be some way to verify that conforming to a particular standard can meet the obligations of a particular directive.

The EU has set up a system to provide a way for manufacturers and suppliers to insure that they are in compliance — the concept of presumption of conformity.  This system is not used for all EN standards.  Indeed, harmonized standards make up a small proportion of the whole body of EN publications.

Remember, a Harmonized Standard has to be linked to a directive.  Indeed the request for the standard has to come from the administrative side of government, specifically to provide a way to meet the requirements of a legislative mandate.  So when a Harmonized Standard is issued there must be a directive that it applies to.  And the standard has got to go through an administrative vetting process to be accepted as meeting the directive’s criteria.

This is why Harmonized Lists don’t get updated right away when standards on the list get updated.  The new revisions have to be reviewed by administrators on the government side to confirm continued compliance.  And then they need to have the completion of the process acknowledged by publication of acceptance in the OJEU, Official Journal of the European Union.

Whew!  Who knew that the use of standardization for government goals could be so complicated?  Guess what!  It’s actually a common situation.  While legislation usually doesn’t change very often, standards are a different story.  Administrators in all jurisdictions are constantly challenged with reviewing changing technical requirements and making sure that their constituents continue to be protected.  And we wouldn’t really want it any other way!

If you have standards questions, or need to purchase them, get in touch with us.  You can order standards at the Document Center webstore, 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).  We’re your Standards Experts!

New ISO 17258 – Benchmarking Six Sigma

January 15th, 2015

There’s a new ISO 17258, “Statistical methods – Six Sigma – Basic criteria underlying benchmarking for Six Sigma in organisations.”  You’ll be able to get a copy in paper format, for pdf download or as part of a multi-user online subscription service from Document Center Inc. now.  The standard gives users a methodology to use in Six Sigma programs to compare your organization with “state-of-the-art.”

Having watched quality initiatives since the 1980’s, I have to admit that I consider Six Sigma to be one of the most transformative statistical tools out there.  Originally developed by Motorola, it was standardized with the release of ISO 13053-1 and ISO 13053-2 in 2011.  It relies strongly on verifiable data, clear business and quality goals, and strong leadership and support.

The ISO 17258 is intended to help you understand what benchmarking is, and what data needs to be collected in order to achieve valid benchmarking results.  This may be for internal, external, or supply chain benchmarking.  And it can be used in Six Sigma and Lean Six Sigma programs alike.

Why would you find ISO 17258 to be helpful?  Data can be collected on many aspects of a business.  Knowing what data will assist you in reaching your goals is essential to any quality project.  And understanding how to confirm the validity of your measurements and how to do your comparisons can make the difference when reaping the returns of such a program.

What’s covered by the standard?  The body of the standard is divided into 8 clauses:

  1. Scope
  2. Reference documents
  3. Terms and definitions
  4. Symbols and abbreviations
  5. General considerations for benchmarking
  6. Benchmark (criteria and criteria measurements)
  7. Benchmarking (steps in the process)
  8. Interfacing with other types of benchmarking

Another great feature are the Annexes.  The first, Annex A, covers the three dimensions of benchmarking (productivity, quality and cost).  Annex B covers a generic table of criteria.  Annex C is a table of those criteria matched to results.  The balance of the 11 Annexes provide you with information on criteria for specific industries like the food industry, automotive, retail, and so on.  A bibliography with 5 citations completes the publication.

If you’re involved in a Six Sigma effort, you’ll want to get a copy of the new ISO 17258.  Head to the Document Center webstore at www.document-center.com and order your authorized copy.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

New IEC/TR 80001-2-5 – Alarm Systems for Networked Medical Devices

January 14th, 2015

There’s a new IEC/TR 80001-2-5, “Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems.” This new publication extends the series on safeguarding computer networks that include medical devices.  It can be purchased in paper format, for pdf download or as part of a multi-user online subscription service from Document Center Inc.

The IEC 80001-2 Series addresses the issue of risk management for networked medical devices in general and this new part specifically deals with the issue of alarms.  To set up your networked alarm system, you’ll need to know how to identify hazards and the causes for them.  Then you’ll need to identify, implement, and verify your risk controls.

How will you know that this new Technical Report applies to your situation?  The essential requirement for using the standard is that your alarm system involves at least one medical device and a communication path that uses an IT (Information Technology) network.

What’s covered by the IEC/TR 80001-2-5?  Of course, there’s the usual scope, referenced documents and definitions sections.  In this case, the clause for terms and definitions is especially lengthy, since having a common meaning to the various terms will assist you in understanding the balance of the document.

Next Clause 4 reviews the functions that this type of alarm system provides.  Clause 5 provides the basis of determining of the type of system you’ll be using.  And Clause 6 covers the issues that your risk management program for your alarm system needs to address.

There’s an additional four Annexes provided in this document.  The first, Annex A, shows you the relationship of this technical report to IEC 60601-1-8.  Annex B discusses the various types of sources that might generate the alarm state.  Annex C reviews what types of systems are appropriate for various conditions.  And Annex D covers the issue of scalability.  Lastly, an 18-item bibliography finishes off the publication along with a 2-page index of terms used.

FYI:  There are a total of 6 Parts to this series currently available.  Additionally, Part 7 and Part 8 are in preparation at this time.

Now you’ll need to get a copy.  Go to Document Center’s webstore at www.document-center.com and order your authorized copy now.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll be able to help you with this and any other standards-related requirements you may have.  Make us your Standards Experts!

New MIL-STD-1791 B USAF Cargo design

January 13th, 2015

MIL-STD-1791, “Designing for Internal Aerial Delivery in Fixed Wing Aircraft,” has just been revised.  The new Revision B is available from Document Center Inc. in paper format, for pdf download, or as part of our multi-user online subscription service.  This document has gone through a series of revisions and redesignations.  We’ll discuss it’s history and why it is called out in U.S. government contracts.

The MIL-STD-1791 was developed to assist vendors and purchasing agents so that cargo design could accommodate the needs of the USAF in assuring safety during transport in fixed wing aircraft.  It is a compendium of design requirements and operating limits from the various aircraft loading manuals and other technical publications.  It also has other useful air transport information.

It was first released in 1985. However in 1997, it was cancelled and republished as a MIL Handbook.  This meant that the various requirements were not binding, but only to be used as guidelines.  Oddly as it seems, this renumbering left the MIL-HDBK-1791 with a date of 12/14/1997 and two change notices with earlier dates, having been ported over from the MIL-STD without any further changes.

In November 2012, the document again went through a renumbering phase, this time taking it back to the status of a MIL-STD.  This new Revision A was issued as a classified document, which meant that it was not available for public distribution.  Finally in June, 2014, an administrative notice reverted the document to Distribution Statement A status, no restrictions on distribution.

The recent release of the Revision B for MIL-STD-1791 is a complete technical update.  You will not find notations in the margins to guide you to areas where revisions have taken place.  As a standard, the document is now available to be called out in contracts and must be adhered to as part of the agreement.  It provides the user with the general design and performance requirements of USAF developed or off-the-shelf cargo used for internal air transport.  And it also covers the procedure for certifying outsized or unusual cargo as well.

Should you need a copy of this 373-page standard, just go to the Document Center webstore 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 got our start distributing Mil-Specs and Standards so we’re very familiar with these documents and their usage.  Make us your Standards Experts!

 

ASTM D4169 – Shipping containers – Updated

January 12th, 2015

ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” has just been updated.  You can purchase your copy of the new 2014 Edition from Document Center in paper format, for pdf download, or as part of our Standards Online multi-user subscription service.  It’s a technical revision of the 2009 Edition, which is now obsolete.

ASTM D4169 is used in the laboratory to judge if a shipping unit can meet the physical demands of the shipping environment and deliver the goods inside intact.  It does this by putting a container or shipping system through a series of tests that match hazard elements that crop up during shipment.

In order to best understand what the changes are in this new revision, Document Center suggests the use of the Redline Edition service.  For a small increase in the price of the purchase, you’ll get a clean copy of the new ASTM D4169.  And you’ll also get a copy of the previous 2009 Edition that has all the changes for the 2014 marked by lines in the margins, cross-outs, and so on.  This “marked-up” edition makes it easy to see exactly what’s been modified.

FYI:  Here’s the general overview of what’s been changed:

  • The AAR (Association of American Railroads) document General Information Bulletin No. 2 has been added to the list of referenced documents.
  • Clause 14 (Schedule G) has been significantly updated.
  • Clause 15 (Schedule H) has been revised.
  • 8 additional citations have been added to the References section at the end of the standard practice.

If you use this document, you’ll want a copy of the new edition as all previous editions are now invalid.  Go to the Document Center webstore at www.document-center.com and order your copy.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been an authorized dealer of the ASTM standards since the 1980’s.  Make us your Standards Experts!

New IWA 17 – Security for Lotteries and other Gambling

January 9th, 2015

It’s Friday, fun day, time to plan for the weekend!  Are you buying Lotto tickets?  Heading to Vegas?  Placing an online sports bet on your favorite team?  Aren’t you glad that there’s the new IWA 17, “Information and operations security and integrity requirements for lottery and gaming organizations”?  This just-published standard helps organizations that provide gambling venues to set up systems that protect themselves and their customers.  And you can get the new release from Document Center now!

IWA 17 is an International Workshop Agreement, based on the World Lottery Association (WLA) publication, WLA-SCS:2012, “WLA Security Control Standard — Lottery and Gaming Security and Integrity Standard for Operations.”  It represents the efforts of the gaming industry to ensure security and integrity, as well as address risk management issues for this sector.

In addition to the gaming industry itself, regulators and other government entities are a stakeholder in this issue.  With many government jurisdictions involved in lottery schemes, the ability to provide constituents with proof of good practice is vital.  And of course, users of such services want to be assured that their identity and financial information is protected, as well as knowing that any games they play are legitimate.

The body of the document provides users with core information on Information Security Management Systems (ISMSs).  It also covers general security control objectives and how to achieve them.  And there are additional requirements specific to the gaming and lottery industries.

However, I find the Annexes A and B to be especially helpful.  They cover both general and industry specific security and integrity control objectives.  Each Annex is divided into a series of tables that address such topics as the organization of security, human resource security, access control and so on.  Various types of game-specific issues are also reviewed:  Instant tickets, lottery draws, internet sales, prize money protection, etc.

Another interesting feature of the IWA 17 is Annex C, which lists the contributors to the standard by jurisdiction, organization and name.  Who knew there were so many lotteries and other gaming businesses out there?

If you need a copy of this standard or any other compliance document, you’ll want to use Document Center for your purchase.  You can order online at www.document-center.com or contact our staff directly by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Standards are available in paper format, for pdf download, or as part of our Standards Online multi-user subscription service.  Make us your Standards Experts!

New ISO 5667-14 – Collecting Water Samples

January 8th, 2015

There’s a new 2nd Edition for the ISO 5667-14, “Water quality – Sampling – Part 14: Guidance on quality assurance and quality control of environmental water sampling and handling.”  It’s available now from Document Center in paper format, for pdf download, and as part of our Standards Online multi-user subscription service.  It is a major technical update from the previous (now obsolete) 1st Edition from 1998.

ISO 5667-14 provides you with quality control procedures to ensure that water samples are correctly handled for test lab processing.  It helps you avoid errors caused by improper sampling, sample pre-treatment, transport and storage.

Why use ISO 5667-14?  It allows you to monitor the effectiveness of your sampling methodology.  You’ll be able to demonstrate that the various stages of your sampling process are appropriate and controlled.  You’ll be able to identify and quantify any errors that do crop up in your process.  And it will help you set up a system for dealing with emergency sampling for pollution incidents or groundwater investigations.

What’s changed in the 2nd Edition of ISO 5667-14?  It’s clear that the document has undergone an extensive revision.  The new 2nd Edition is 42 pages compared to the 24 pages of the 1st Edition.  The difference is that there are many more clauses in the new update.  Both editions start with the scope, reference documents and definitions clauses.  However, after that the 2nd Edition gets much more specific than before.  Here is the list of the expanded requirements sections (up from 5 clauses to 10):

  • Sources of sampling error
  • Sampling quality
  • Strategy and organization
  • Sample collection and handling
  • Sample identification
  • Field sample protocol
  • Transport and storage of samples
  • Sampling quality control techniques
  • Analysis and interpretation of quality control data
  • Independent audits

FYI:  The clauses in the 1st Edition were just Sources of sampling error, Sampling quality control techniques, Transport, stabilization and storage of samples, Analysis and interpretation of quality control data, and Sample identification and records.

The Annexes have also been updated.  The 1st Edition contained just 2: Annex A on Control charts and Annex B, the Bibliography.  The new 2nd Edition has 3, as well as a separate Bibliography.  They are:

  • Common sources of sampling error
  • Control charts
  • Sub-sampling using a homogenizer

The ISO 5667-14 is one of 21 parts for the ISO 5667 series.  If you need this publication, any of the series, or any standard at all, please go to the Document Center webstore at www.document-center.com to order your authorized copies.  We’ve been providing our customers with specifications and standards and the services to promote correct usage since 1982.  If you’d like more information, feel free to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Make us your Standards Experts!

New CSA Z434 edition on robotic safety released

January 7th, 2015

There’s a new 2014 Edition for the CSA Z434, “Industrial Robots and Robot Systems – General Safety Requirements,” and it’s available now from Document Center Inc.  The release of this new update means that three important safety standards for robotics are now “harmonized.”  They are the CSA Z434, the RIA R15.06, and the ISO 10218 series.  While there may be some national differences, the documents are now based on the same information.

What does this mean?  Let’s take a look at the recent changes for all three standards.  First, the RIA R15.06 has been published since 1986.  It was the basis of the two parts of the ISO 10218 series:  ISO 10218-1, “Robots and robotic devices – Safety requirements for industrial robots – Part 1: Robots,” from 2006 and ISO 10218-2, “Robots and robotic devices – Safety requirements for industrial robots – Part 2: Robot systems and integration,” from 2011.   You’ll notice that the R15.06 material was split into two sections, probably to ease the development of the documents at the international level.  The RIA R15.06 was last updated in 2012, this time as the U.S. national adoption of the ISO standards.

Now with the RIA R15.06 in use in the U.S. and the ISO 10218 series adopted by the European Union, Canada was ready to update it’s robotics safety standard as well.  The new CSA Z434 is the Canadian national adoption of the ISO 10218-1 and ISO 10218-2, but with national differences.

What does this mean for manufacturers and users of industrial robots and robot systems?  If you have facilities or sell to a variety of jurisdictions, it will be much easier for you to integrate the information from these three standards.  Since they are all based on consistent information and format, you’ll be able to spot national differences quickly.

So often we speak about harmonization of standards.  Here is a clear example of an industry that has made great efforts to develop a standard that can be used on a global basis.  With this success, we can expect additional areas of robotics to be addressed in upcoming standards updates.

And if you need a copy of any of the standards mentioned in this posting, please head to the Document Center webstore at www.document-center.com.  Here you’ll find over 1,000,000 standards revisions available for ordering.  Many can be purchased in both paper format and for pdf download.  And our Standards Online subscription service can provide multi-user access as well.  Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  Make us your Standards Experts!

Document Center’s Top 20 Standards for 2014

January 6th, 2015

It’s that time of year!  Time for Document Center’s Top 20 Standards for 2014!  I always love seeing what standards sold the most and I bet you do too.  So here’s our list for 2014, with a link to each publication in case you need to order a copy:

  1. IPC-A-610, Revision F, Acceptability of Electronic Assemblies
  2. ASTM E18, 2014a Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
  3. AS-9102, Revision B, Aerospace First Article Inspection Requirement
  4. ISO 11607-1, Amendment 1 for the 1st Edition, Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems Requirements for Forming, Sealing and Assembly Processes
  5. IPC J STD 001, Revision F, Requirements for Soldered Electrical and Electronic Assemblies
  6. ISO 9001, 4th Edition Corrected Reprint, Quality Management Systems — Requirements
  7. ISO 11607-2, Amendment 1 for the 1st Edition, Packaging for Terminally Sterilized Medical Devices – Part 2: Validation
  8. 21CFR Parts 800 to 1299, 2014 Edition, Food and Drug Administration Regulations
  9. BS EN ISO 14971, 2012 Edition, Medical devices. Application of risk management to medical devices
  10. ISO/DIS-13485, Proposed 3rd Edition Public Review Draft, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  11. IEC 60601-1-2, Edition 4.0, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
  12. ISO 11135, 2nd Edition, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
  13. ISO/DIS 9001, Proposed 5th Edition Public Review Draft, Quality management systems – Requirements
  14. ASTM A370, 2014 Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
  15. ISO 10993-3, 3rd Edition, Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  16. MIL-STD-883, Revision J with Amendments 1 to 4 Interfiled, Microcircuits
  17. AMS 2404, Revision G, Plating, Electroless Nickel
  18. AMS 2770, Revision L, Heat Treatment of Wrought Aluminum Alloy Parts
  19. AS 9101, Revision E, Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations
  20. ASTM A240, 2014 Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
  21. BS EN 1041, 2008 Edition with Amendment A1, Information supplied by the manufacturer of medical devices

Note:  20 and 21 tied!

If you’d like a copy of any of these best-sellers, or any standard at all, check out our webstore at www.document-center.com.  It’s filled with helpful tools to help you identify and purchase the documents you need.  And if you’d like to learn more about Document Center and the many services we offer our clients, please contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New ISO 11608-1 3rd Edition available!

January 5th, 2015

ISO 11608-1, “Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems,” has just been updated.  The new 3rd Edition is available now from Document Center Inc. in paper format, for pdf format or as part of our Standards Online multi-user subscription service.  It contains a myriad of changes to the 2nd Edition, which is now obsolete.

If you use ISO 11608-1, you’ll need this new edition.  Here’s a list of technical changes that will affect your business:

  • Legacy references to “pens” have been removed in favor of “NISs” (Needle-based Injection Systems).
  • Clause 5.5 has been updated.
  • Table 3 has been corrected in a couple of places.
  • In clause 10.1, an explanation is added to Note 1.
  • A number of changes have been made to clause 10.5.
  • The temperature range in clause 10.8 has been changed.
  • Corrections have been made to clauses 10.10.4 and 10.10.5.
  • Modifications have been made to clause 13.2.3.

Of course, if you use this series of standards, you’ll want to know if additional changes are going to be made to the remainder of the parts of the series.  While Part 1 is now updated, the rest of the series is unchanged as listed below:

  • ISO 11608-2, 2nd Edition, Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles
  • ISO 11608-3, 2nd Edition, Needle-based injection systems for medical use – Requirements and test methods – Part 3: Finished containers
  • ISO 11608-4, 1st Edition, Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
  • ISO 11608-5, 1st Edition, Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions

However, some changes are underway.  There is a working draft for a Part 4 revision, which should be available as a draft for public comment in 2016.  And there’s initial work being done on a new Part 6 (“Needle-based injection systems for medical use –Requirements and test methods — Part 6: Bolus Injectors”) and new Part 7 (“Needle-based injection systems — Part 7: Requirements for accessibility for persons with visual impairment”).  No drafts on these two new parts are being distributed for comment at this time.

Of course, you need a copy of the new 3rd Edition for ISO 11608-1.  Just go to the Document Center webstore at www.document-center.com and order now!  Or if you prefer, contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Since these are copyright documents, you’ll want to get your copies from an authorized dealer like Document Center Inc.  And since we’ve been helping folks like you with standards since 1982, make us your Standards Experts!