Category: Hot Topics in Standardization

Have a safe and happy 4th of July!  That’s our message for this weekend and it is made possible by those Standards Professionals who write fireworks standards! Here in the U.S., you’ll find fireworks standards provided by NFPA (the National Fire Protection Association) and AFSL (the American Fireworks Standards Laboratory).  In Europe, this topic is covered by the CEN Technical Committee 212 and ISO Technical Committee 264.

AFSL has issued the following standards:

• AFSL 101 – Standard for Combination Items
• AFSL 102 – Standard for Comets, Mines, and Shells
• AFSL 103 – Standard for Firecrackers
• AFSL 104 – Standard for Fountains
• AFSL 105 – Standard for Ground Spinners and Chasers
• AFSL 106 – Standard for Specialty Items
• AFSL 107 – Standard for Party, Trick, and Toy Smoke Devices
• AFSL 108 – Standard for Reloadable Tube Aerial Shells
• AFSL 109 – Standard for Roman Candles
• AFSL 110 – Standard for Sky Rockets, Missiles, and Helicopters
• AFSL 111 – Standard for Hand-Held Sparkling Devices
• AFSL 112 – Standard for Wheels
• AFSL 113 – Standard for Girandolas
• AFSL 114 – Standard for Crackling Strips

You’ll find these standards at the AFSL website.  The publication includes all the standards plus a series of Appendices which cover general topics like the chemical that can and cannot be used, transportation regulations and so on.  I admit — Every kind of fireworks goody I can think of is certainly covered here!

NFPA on the other hand provides the following 3 standards:

• NFPA 1123, Code for Fireworks Display
• NFPA 1124, Code for the Manufacture, Transportation, Storage, and Retail Sales of Fireworks and Pyrotechnic Articles
• NFPA PYR 1129, Standard Method of Fire Test for Covered Fuse on Consumer Fireworks

In Europe, there’s quite a number of standards on this topic.  It’s easiest just to peruse the list using the ICS classification code for fireworks.  Here is the link to our Document Center List of Standards on Explosives, Pyrotechnics and Fireworks.  You’ll find it’s quite lengthy!

So there you have it.  Lots of fireworks standards available — All developed with one thing in mind:  Keeping us safe when we get the thrill of seeing those wonderful fireworks displays like those that will be happening this 4th of July!  Here at Document Center Inc., we hope you and yours have a great holiday and a safe one!

Since the inception of the “New Approach” back in 1985, the key concepts of the use of Harmonized Standards and Presumption of Conformity have provided medical device vendors with a valuable tool in meeting legislative and regulatory requirements in the EU.  But over the last few years, the addition of the Z Annexes to many of these documents have certainly caused many of Document Center’s clients headaches!  So I thought that a little review of the New Approach, Harmonized Standards and Presumption of Conformity might be in order.

The New Approach was developed to assist Europe develop a common market.  It makes use of standardization as a tool for creating common requirements within the group of nations that make up the EU.  It relies on legislation to mandate performance levels and a standardization scheme to provide a path to meeting those performance levels.  This use of a body of standards (your harmonized list) to fulfill legislative mandates is know as the presumption of conformance.

Of course, use of the harmonized standards is not the only path to conformance.  A company can choose another solution if they prefer.  However, they will need to “make their case” for conformance in a way that is not necessary had they decided to meet the requirements of specific harmonized standards instead.

Why have standards on the harmonized list for medical devices run into so many issues with the intended “presumption of conformity?”  The Medical Device Directive, The Active Implantable Medical Device Directive and the In Vitro Diagnostic Medical Device Directive all have articles that in some cases are not strictly met by clauses in the corresponding standards adopted from ISO and IEC.  These gaps may be spotted by a review of the Annex Z’s in the documents in question.

These Annexes match legislative mandates to specific clauses within a particular standard.  Where there are discrepancies, this is noted.  Additionally, certain standards may not address all the requirements of the legislation, but only particular articles.

During the last couple of years, as certification has raised flags regarding the correlation between the legislative requirements and the reality of the harmonized standards, these Annex Z’s have been undergoing changes.  And since the changes reflex a degree of compliance to the legislation that was not considered practicable when the standards were first developed, you can see that there’s going to be an issue raised for many medical device manufacturers.

Of course, standards do represent “state-of-the-art” in many cases.  However, with increasing concerns about risk assessment, etc., the use of the medical device harmonized standards no longer confer the degree of conformance as they once did.

When will this issue crop up for you?  You will have to address it when a new edition of one of the standards on the harmonized list is updated.  The “date of cessation of presumption of conformity” will be your target date for compliance.  That is, you will need to have moved from the old edition to the new by that date on the harmonized list publication.  Any device already placed on the market in Europe by that date will not be affected.  However, any device sold after that date will need to meet the new update.

What is required to make the move from one edition to another?  You will need to confirm that your product’s “justifications” for conformity are valid using the new standard’s requirements by that expiration date.  In order to determine the changes you’ll need to make to your product (if any), a gap analysis is required.  You’ll review the two editions and see if the changes in the revised document impact your product and it’s “technical file.”  Should it not impact your product, nothing further is required.  If it does, retesting will be in order.

It is unfortunate that some of the basic tenets of the New Approach have run into difficulties where medical devices are concerned.  Certainly, it appears that some of the trouble has occurred because of the preference of the European system to adopt standards developed at the International level when possible.  Since Europe makes up 20% of the membership of the International standards organizations, it is a great economic benefit to have standards aligned at both the international and European regional levels.  However, in the case of some of these medical device standards, the degree of risk mitigation is not stringent enough at the international level to meet the European legislative requirements.

Of course, these changes are rippling through the standards community even as we speak.  Will the net result be a change to the legislation or changes to the standardization?  Only time will tell…

If you need help with your documentation for compliance, turn to Document Center Inc.  We’ve helped thousands of companies just like yours.  Reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Or head to our website at www.document-center.com.  We’re your Standards Experts!

Data Privacy and Strategic Standardization – It’s a familiar plot line for those of us in the standards business.  It has to do with the use of standards and regulations as a tool for market manipulation.  It’s sometimes done in committee work far from the public eye, but with data privacy it’s right up front.  The case in point:  Data protection rules being put forward by the European Union.  It was reported in the Wall Street Journal yesterday and certainly got my attention!

What’s most interesting to me is that the chief negotiator for the European Parliament made the situation clear:  Jan Philipp Albrecht expects the data protection law to have a beneficial effect on European web companies equal to the impact of the adoption of GSM had on telecommunications companies back in the 1990’s.

For those of you who remember, at that time Qualcomm owned the CDMA chip market. Everything was great until the Europeans decided to standardize on GSM, hoping to push the U.S. company out of the market.  While Qualcomm is still doing just fine, the European move to GSM proved a tremendous boon to such companies as Nokia and Ericsson.  Albrecht specifically referred to this incident recently.

No wonder U.S. Internet companies are starting to spend so much time and effort in Europe!  There’s no doubt that the EU regulators are looking a Google and other U.S. Internet giants with an eye to the competitive environment.  And how could such regulations skew the marketplace in favor of the European market?

As regulators there say, a move to promote products and services already being developed in Europe specifically to address these new restrictions will likely put European companies ahead of others.  Should these type of regulations become global, it could be a competitive disadvantage for the large U.S. Internet giants.

In a perfect world, standards would be ruled by technology.  But in our real one, politics and financial advantage play a huge role and standards developers and users shouldn’t forget it.  If you are not paying attention to the political forces that shape your industry, you stand a good chance of being blindsided.

As part of your standards program, don’t forget to pay attention not only to what’s impacting your company now, but what’s brewing for the future.  You’ll want to capture information from those in your company who participate in standards work.  And you’ll want to get feedback from staff familiar with the various markets you’re selling in.  There’s always someone looking to find a way to get some of what you have!  And it may be happening where you least expect it.

For standards and services to support your use of standards, make Document Center your first choice.  You can order standards online at our webstore, www.document-center.com.  And you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) with any questions or orders you may have.  Make us your Standards Experts!

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!

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!

There’s a big U.S. holiday coming up for the 4th of July (Independence Day) and what’s more American than Baseball in the summertime?  Well, baseball has been exported successfully to Japan and right now there’s a controversy brewing there about the actual baseballs used in the sport.  Which leads me to wonder, how do they figure all these things out?  And that means Baseball Standards!

The issue in Japan centers on the increase of the coefficient of restitution of the ball (the bounciness that is affected by the material at the core of the ball).  Turns out that there’s a number of standardized tests that are used to measure the various features of baseballs, to insure that the balls meet the requirements of the various sports associations (including NPB, Nippon Professional Baseball).  These baseball standards are:

• ASTM F1887, Standard Test Method for Measuring the Coefficient of Restitution (COR) of Baseballs and Softballs,
• ASTM F1888, Test Method for Compression-Displacement of Baseballs and Softballs, and
• ASTM F2845, Standard Test Method for Measuring the Dynamic Stiffness (DS) and Cylindrical Coefficient of Restitution (CCOR) of Baseballs and Softballs.

And if you’re suspecting that the home run stats are being affected by the bat instead, here’s the various tests that can be used to check it out:

• ASTM F1881, Standard Test Method for Measuring Baseball Bat Performance Factor,
• ASTM F2219, Standard Test Methods for Measuring High-Speed Bat Performance,
• ASTM F2398, Standard Test Method for Measuring Moment of Inertia and Center of Percussion of a Baseball or Softball Bat, and
• ASTM F2844, Standard Test Method for Displacement Compression of Softball and Baseball Bat Barrels.

To review more standards on sports equipment and playing fields, we have a Document Center page for the ASTM Volume on Standards for Sports Equipment and Facilities.  And there’s also the Document Center List of Standards on Outdoor and Water Sports Equipment.

Going to an Amusement Park for the holiday instead of a ball game?  There’s Standards on Amusement Rides and Amusement Parks too!

Count on Document Center to help you find the standards you need.  We’re on the web at www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  No matter what kind of standards you need, we’ve got you covered.  We’re your Standards Experts.