Food Safety Standards News

At Thanksgiving I like to do a post on food safety, and the biggest food safety news this month are the eight new ISO testing standards for infant formula and adult nutritionals.  Concern about the safety of infant formulas (and the similar products for the elderly) has been in the news the last several years.  Now ISO, in conjunction with IDF (the International Dairy Federation) and AOAC International’s SPIFAN project (Stakeholder Panel on Infant Formula and Adult Nutritionals), has released the first of what should be an extensive group of standards to promote quality in these products.

Here’s the list of the new eight standards:

ISO 16958, Milk, milk products, infant formula and adult nutritionals — Determination of fatty acids composition — Capillary gas chromatographic method

ISO 20633, Infant formula and adult nutritionals — Determination of vitamin E and vitamin A by normal phase high performance liquid chromatography

ISO 20634, Infant formula and adult nutritionals — Determination of vitamin B12 by reversed phase high performance liquid chromatography (RP-HPLC)

ISO 20637, Infant formula and adult nutritionals — Determination of myo-inositol by liquid chromatography and pulsed amperometry

ISO 20638, Infant formula — Determination of nucleotides by liquid chromatography

ISO 20639, Infant formula and adult nutritionals — Determination of pantothenic acid by ultra high performance liquid chromatography and tandem mass spectrometry method (UHPLC-MS/MS)

ISO 20647, Infant formula and adult nutritionals — Determination of total iodine — Inductively coupled plasma mass spectrometry (ICP-MS)

ISO 20648, Infant formula and adult nutritionals — Determination of chromium, selenium and molybdenum — Inductively coupled plasma mass spectrometry (ICP-MS)

As you can see, each of these standards provides you with the test requirements for a specific nutrient (the ISO 20648 is for what’s termed ultra-trace minerals).

Why should you use these new food safety standards?  First, manufacturers of infant formula and official control laboratories can use them to check compliance with regulations.  Secondly, they are going to be proposed  for inclusion in the Codex Alimentarius as so-called Type II methods (i.e. reference methods).  This will enable them to be used for dispute resolution internationally.

What do these test methods verify?  These ISO standards will be used to confirm that infant formulas and adult nutritionals are providing the adequate nutrition necessary for their user populations.  In other words, they’ll be used to prove that these products deliver on their promise of nutritional validity.

How can you get your copies of these and other food standards?  Use the Document Center Inc. webstore at to purchase your ISO standards.  As an authorized distributor, Document Center not only provides standards from around the world but also gives you the tools to find them.  For example, for documents like the one’s reviewed here there’s a Document Center List of Standards on General Methods Of Tests And Analysis For Food Products.  Other food standards can be found by using the links on our Document Center List of Standards on Food Technology.

If you have questions or want additional information on Document Center’s services and products, please contact our staff.  They can be reached by phone (650-591-7600) or email (  We’ve been selling standards since 1982, so make us your Standards Experts!

IEC 60794-1-1 Updated – Optical fiber cables

IEC 60794-1-1, “Optical fibre cables – Part 1-1: Generic specification – General,” has just been updated.  The new Edition 4.0 is available from Document Center Inc. now.  This 4th Edition revision replaces Edition 3.0 from 2011 and is a technical update.  We’ll review the document, the series, and the updates now.

The IEC 60794 series addresses optical fiber cables and the IEC 60794-1-1 is the overview document.  It applies to the optical fiber cables that are used with communication equipment and other similar products, as well as to cables that have both optical fibers and electrical conductors.  It sets up the uniform generic requirements for geometrical, transmission, material, mechanical, ageing (including environmental exposure), climatic and electrical properties of both optical fiber cable and cable elements.  You’ll use it in conjunction with other parts of the IEC 60794 series as well.

What are the significant changes in IEC 60794-1-1 Edition 4.0?  Definitions, graphical symbols, terminology and abbreviations have been expanded to further the “overview” mission of the document.  Other changes also support this role for the publication.  You’ll now find updated and expanded optical fiber, attenuation and bandwidth sections too.  Should you need specific guidance on the changes in this publication, there is a redline edition available for you.

FYI:  The IEC 60794 series comes in 5 primary parts:  Part 1 (in approximately 7 sections) for generic specifications, Part 2 (in about 13 sections) for indoor cables, Part 3 (currently 10 sections) for outdoor cables, Part 4 (4 sections) for aerial optical cables, and Part 5 (3 sections) on microduct optical cabling.

You may need one or more of the documents in the IEC 60794 series and since they’re copyright you’ll want to make sure you purchase your copies from an authorized distributor like Document Center Inc.  IEC standards can be purchased with confidence at our webstore,  Here is the link directly to the order page for the IEC 60794-1-1.  You’ll have the option of choosing delivery in paper format or as a pdf download.

Perhaps you have additional questions or you’d like information on company-wide access for this publication.  Just check in with our staff.  They can be reached by phone (650-591-7600) and by email (  We have an array of products and services that will make your management of your standards collection worry-free.  Make Document Center your Standards Experts!

What is an NSB?

Acronyms are a fact of life in the standards business, but many times they are used without adequate definition.  So as part of my on-going efforts to educate you, the standards user, here’s information on “What is an NSB?”

NSB stands for “National Standard Body” and is the way to describe standards organization that have countries as their jurisdiction.  So some examples would be ANSI (the American National Standards Institute) here in the U.S., BSI (the British Standards Institute) in the U.K. and JISC (the Japanese Industrial Standards Committee) in Japan.

NSB’s usually are an arm of a particular government.  This is because standardization developed in many countries as part of the legal and regulatory structure.  Our U.S. system, with a large number of standards developing organizations (many of them trade associations), is not the norm.  Most NSB’s are quasi-governmental organizations with varying degrees of integration into other government structures.

Let’s take a look at a couple of the larger ones.  DIN (the German Institute for Standardization — Deutsches Institut für Normung) is a private, non-profit organization.  It was founded in 1917 as the “Standards Association of German Industry.”  In 1975 DIN entered a public-private partnership with the German Federal Republic by signing the Standards Agreement.  This makes it the acknowledged national standards body that represents German interests in European and international standards organizations.  It has a wide range of mandates.  The sales of standards provide the Institution with it’s primary income (about 70%.)

Another NSB you should be familiar with is BSI, the British Standards Institute.  Originally established as the British Engineering Standards Association, it is a private company incorporated by Royal Charter (first issued in 1929.)  This Charter sets out the purpose of BSI and defines in broad terms its range of activities.  These include its functions as a standards body, as well as serving as a training, testing and certification services facility.  This means that BSI not only develops standards and participates in standards development on a regional and international level, it also certifies products to the standards it publishes.

How does ANSI, as the U.S. NSB, differ from these other organizations?  ANSI does not write standards.  Instead, it adopts standards produced by other organizations within the U.S.  So many “ANSI” standards are actually written by such groups as ASME, OPEI, AWWA, and so on.  And while ANSI “represents” the U.S. in regional and international standardization efforts, many times this is achieved by authorizing one U.S. standards body or another to oversee participation.  So there is a degree of separation here in the U.S. not found in most other jurisdictions.  Or to put it another way, standardization is more of a “grass-roots effort” here than elsewhere.

One easy way to determine what organization is the NSB for any given country is to check out the list of members and affiliate members of ISO, the International Organization for Standardization.  Since ISO is solely comprised of NSB’s, the list will often help you to determine who’s who in standards.  Here is the link to the ISO List of Members page:  There are a few countries that are not represented in the list.  But with a total of 162 members, its pretty comprehensive!

Of course, it’s not easy to keep track of 162 national bodies, plus the 450+ standards developers in the U.S., various International Standards Bodies, and the many other standards developers around the world.  Most standards users find it advisable to choose an authorized distributor like Document Center Inc. to manage their collections.  Why?  Because a standards aggregator like Document Center Inc. has information coming in daily about new and revised publications.  Only a professional organization like Document Center can deal with the sheer volume of data generated daily.

Search for standards at our webstore,  There you’ll find a consolidated catalog of standards from around the world.  Order the documents you need, then depend on our superior notification service to keep you informed of changes moving forward.  Remember:  Document Center Inc. has been helping folks like you since 1982.  Make us your Standards Experts!

New EN 16654 Child protection for closing doors

EN 16654, “Child protective products. Consumer fitted finger protection devices for doors. Safety requirements and test methods,” has just been released.  It’s another example of the many standards directed towards the protection of children from hazards.  The new 2015 Edition, a first release, is now available from Document Center Inc.

EN 16654 addresses the challenge of avoiding crushing injuries to children when doors in buildings are closing.  The products covered are consumer-fitted products intended to be mounted on hinged doors in a household environment.  These products are based on one or more of three principles: hazard shielding, shut prevention or shut control.  The standard does not address products that keep the door in a fixed position.  Nor does it address products that are intended on being installed by professionals.  Friction hinges are also excluded.

The EN 16654 specifies both requirements and test methods for these products.  These requirements have been developed strictly for the European market, but may prove valuable for companies selling in other jurisdictions.

Of course, such products support the need of parents to be assured that the environments in which their children are being raised are safe.  Having standards define the parameters of good design means that consumers can make their purchasing decision confident in its effectiveness for preventing injury.  Again, this reinforces the fact that standards and standardization are very much in support of the health and welfare of people the world over.

All EN standards are distributed as national adoptions and all are copyright.  You can purchase your EN standards from Document Center Inc. with complete confidence that you’re using an authorized distributor.  Just go to our webstore at to place your order.  Here’s the direct link for the order page for BS EN 16654.  Other national editions in English should be available soon.

Contact our staff for more information.  You can  reach them by phone (650-591-7600) or email (  We’ve been working with standards since 1982 and have the knowledge to help you with your compliance documentation challenges.  Make Document Center Inc. your Standards Experts!


New AAMI CN6 – Connectors for liquids and gases

Sometimes human error can be avoided through good design.  In the case of the healthcare industry, many errors caused by connecting patients to the wrong gases or liquids can be avoided by connector design.  So AAMI has been issuing a series of connector standards recently, and the CN6 is the latest.  AAMI CN6, “Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications ,” is available now from Document Center Inc.  You’ll be able to get copies both in paper format and as pdf downloads.

First, the AAMI CN6 is a provisional standard.  It has been developed from a draft of the proposed ISO 80369-6 document.  For all of you who are concerned about whether to purchase this provisional standard now or to wait for the ISO release, you’ll be pleased to know that when the ISO document is published, you’ll get the AAMI adoption at no additional charge.

Also, the AAMI committee is chaired by the head of the FDA’s CDRH Standards Program (Center for Devices and Radiological Health), along with a medical device industry representative.  And, should the ISO 80369-6 not make it through the adoption process and ISO and not be published after all, the AAMI CN6 will be withdrawn.

Also of note is the fact that the ISO 80369 series will eventually consist of 8 Parts.  This will mean that issues of unique connectors for such applications as breathing systems, limb cuff inflations, urinary applications and so on will all be defined.

Now for the AAMI CN6.  The standard addresses connectors used for neuraxial applications.  These are intended to administer medications for anaesthesia procedures, remove cerebro-spinal fluid, and so on.  The 65-page document is a wealth of information.  It covers general requirements, dimensional requirements and performance requirementsin the body of the text.  Then the 10 (count them, 10!) Annexes delve into the details of test procedures, rationale and guidance, small bore and reference connectors, etc.  A 24 item Bibliography completes the document.

Why has AAMI CN6 been published?  Very simply to promote patient safety.  The benefits of standardizing connectors in a hospital or other healthcare setting to avoid errors which can sometimes lead to fatalities are clear.  As a prime proponent for healthcare and medical device safety, AAMI feels compelled to help industry achieve this worthy goal as soon as possible.

How can you get your copy of AAMI CN6?  Since AAMI standards are covered by the laws of copyright, you’ll need to choose an authorized distributor like Document Center Inc. for your purchase.  Use our webstore,, to order online.  Here is the link directly to the order page for AAMI CN6.  Or feel free to contact our staff by phone (650-591-7600) or email (  We work with many companies in the medical device space and have tools available to make your documentation challenges easier.  Make us your Standards Experts!


Updates released for ISO 22442 series

The ISO 22442 series for medical devices that use animal tissues has been updated.  There are new 2nd Editions for both ISO 22442-1 and ISO 22442-2.  The new revisions are available from Document Center Inc., an authorized distributor of ISO standards.  The series addresses issues linked to animal tissues (and their derivatives.)  These materials can provide performance benefits in such devices as heart valves, bone substitutes, collagen implants, and so on.

We’ll discuss each of the new editions separately below:

ISO 22442-1, Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management

ISO 22442-1 covers medical devices other than in vitro diagnostic devices.   The animal tissues addressed by the standard are non-viable (or have been rendered so.)  You’ll need to use ISO 22442-1 with ISO 14971, since it is not a “standalone” standard.

Changes in this new edition are minor.  From a cursory review, revisions have been made to such things as dates in the referenced documents section, an added reference to Part 4 in the foreward, and so on.  However, the 2nd Edition does cancel and replace the 1st Edition from 2007, so if you use this document you’ll need a copy of the new update.

ISO 22442-2, Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling

The new 2nd Edition for Part 2 is also a minor revision.  The standard covers the issues of controlling quality and purity throughout the procurement process.  This is especially important since contamination prior to inclusion in a medical device can lead to negative outcomes for patients.

Again the new 2nd Edition cancels and replaces the previous 1st Edition from 2007.  You will need to get a copy if you use the standard in your business.

Note: ISO 22442-3 (Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents) and ISO/TR 22442-4 (Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes) are not under revision and remain valid at this time.

Now to get a copy.  You can rely on Document Center Inc. to provide you with not only the standards you need, but also the supporting services to keep your collection current.  Order any standard on our webstore,  Here’s the direct link for the order page for ISO 22442-1 and the order page for ISO 22442-2.

Prefer to work with a person?  Document Center’s staff is familiar with the standards you use and can answer many of your standards questions.  You can reach us by phone at 650-591-7600 or by email at  We’ve been working with standards since 1982 and have helped tens of thousands of customers with their compliance requirements.  Make us your Standards Experts!

New ASME B18.2.2 2015 Edition

ASME B18.2.2, “Nuts for General Applications: Machine Screw Nuts, Hex, Square, Hex Flange, and Coupling Nuts (Inch Series),” has just been updated.  The new 2015 Edition is available now from Document Center Inc.  It is part of the B18 fastener series published by ASME, the series for defining the nuts, bolts, and other fasteners that are a part of so many products and installations.

What’s in the ASME B18.2.2?  The standard covers  the complete general and dimensional data for the various types of inch series square and hex nuts.  It also has appendices covering gaging of slots in slotted nuts, wrench openings for nuts, and the formulas that are the basis for the dimensional data.  It is recognized as an American National Standard and was once known as ANSI B18.2.2.

ASME has been publishing fastener standards since the beginning of the 1900’s and the first standard for Proportions for Machine Screws actually predates the first publication of the Boiler Code.  Today there are approximately 70 active standards included in the B18 fastener series.

You’ll want to get your copy of the new Edition from an authorized reseller like Document Center Inc.  Use our webstore to order online at  Here is a link to the order page for the new ASME B18.2.2.  If you prefer, you can contact our staff by phone (650-591-7600) or email (  We are available to assist you with all your standards questions and requirements.  Make Document Center Inc. your Standards Experts!

IEC 60086-2 Updated – Primary Batteries

IEC 60086-2, “Primary batteries – Part 2: Physical and electrical specifications,” has been updated with the release of the new Edition 13.0.  The IEC 60086 series is one of the most frequently used battery specifications.  So an update to the Part 2 is significant.

Who should be using the IEC 60086-2?  Primary battery users, device designers and battery manufacturers will all find the series useful.  It provides the specifics of form, fit and function for primary cells and batteries.

What is contained in IEC 60086-2?  The standard provides the physical dimensions, discharge test conditions and discharge performance requirements for primary batteries.  It covers categories 1, 2, 3, 4, 5 and 6.  Dimensional drawings for various types of batteries are included as 29 figures (the document used to be labeled “specification sheets”).  The 4 Annexes cover additional information on batteries according to the application, an index and a cross-reference index, and common designations.  A 5-item bibliography completes the publication.

What’s new in the IEC 60086-2 13th Edition?  IEC provides the following guidance:

“Significant changes from the previous edition are test changes to battery types R03, LR03, R6, LR6, PR70, PR41, PR48, 6F22, 6LR61, 6LP3146 4LR25-2, R14, LR14, R20, LR20, CR2025, and CR2032, adding the 5AR40 back into the standard, addition of common designations, addition of two new battery types FR14505 and FR10G445, deletion of battery types LR53, R40, 2EP3863, 6F100, and general editorial changes.”

FYI: The Edition 13.0 cancels and replaces the previous Edition 12.0 from 2011.

How can you get a copy of IEC 60086-2 13th Edition?  IEC reminds you that it is essential to purchase your copy from an authorized distributor like Document Center Inc.  All IEC standards can be purchased in both paper and pdf format from our webstore,  Here is a link directly to the order page for IEC 60086-2.

Many of our customers prefer multi-user access so a number of folks in the organization have online viewing rights.  Our Standards Online service solves this very problem.  Contact our staff for more information on how your company can start up a subscription service for your standards collection and improve your use of these important compliance documents.  You can reach us by phone (650-591-7600) or email (

Document Center has been helping folks like you solve your standards requirements since 1982.  Make us your Standards Experts!

ISO 7637-1 Updated

ISO 7637-1, “Road vehicles – Electrical disturbances from conduction and coupling – Part 1: Definitions and general considerations,” has been updated.  The new 3rd Edition is available from Document Center now.  The document provides information on electrical and radio-frequency disturbances that could affect the performance of the computer components in your car!

The use of electronic devices in automobiles is now ubiquous, with chips controlling many functions (including changing lanes safely in some instances) and displaying information for the driver.  So rf and electrical interference in the vehicle electrical system can be disasterous.

The ISO 7637 series addresses the problem of dealing with the various electrical distubances that are generated by various parts within a vehicle itself.  These might be from such parts as your  ignition, relay contacts, alternator, injectors, and other accessories.  The series is concerned with the problems that these electrical transient distubances can create as they are transmitted through the wiring of the car (supply and other lines) to various electronic components.

ISO 7637-1 is the overview standard, providing you with definitions and basic information on how the series is to be used.  There is a new Clause 5 in this edition on general test conditions.  This new clause provides you with the test conditions that are found in all the parts of the series (considered to be a series of bench test standards.)

Annex A, which was added to the standard with the adoption of Amendment 1 for the 2008 2nd Edition, is still part of the document.  As you probably know, it is normative, which means that it’s use is mandatory.  And there have also been additions to the bibliography in this new update.

The committee in charge of the ISO 7637 series is also working on two new parts that will be included in the series soon.  They are:

  • Part 4: Electrical transient conduction along shielded high voltage supply lines only
  • Part 5: Enhanced definitions and verification methods for harmonization of pulse generators according to ISO 7637–2 (to be released as a technical report)

Now in order to comply with copyright law, you’ll want to use an authorized distributor like Document Center Inc. for all your standards purchases.  Our webstore has standards from organizations based all over the world.  You’ll find it at  Here’s the direct link to the order page for ISO 7637-1.  You’ll find it available for purchase in both paper format and for pdf download.

Of course, many of our customers are interested in multi-user access to support the entire organization.  Our Standards Online subscription service is ideal for this purpose.  Contact our staff by phone (650-591-7600) or email ( to find out more.

Document Center has been providing standards and support to folks like you since 1982.  Make us your Standards Experts!

Final Draft for ISO 13485 3rd Edition is here!

ISO 13485 is under revision and the proposed 3rd Edition is at the final stage!  Titled “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes,” the final draft is up for voting by ISO membership from 10/29/2015 to 12/29/2015.  It is expected to be adopted and published soon thereafter.

Let’s take a moment to review what ISO drafts are, their stages, and why you might be interested in purchasing a draft document.  We’ll also suggest when you might want to wait until the authorized edition for a draft is released.

ISO drafts come in three basis stages:  The Committee Draft (ISO/CD) which is NOT publicly distributed, the Draft International Standard (ISO/DIS) which is publicly distributed for comments, and the Final Draft International Standard (ISO/FDIS) which is presented as a finalized edition for ISO acceptance.  If you look at the ISO website, you can find information on what stage a publication is in (relating to the three stages above plus withdrawn or in force status).

So, if you see an ISO standard with the acronym ISO/CD at the start, the only way you’ll be able to get a copy is to find out what organization in your country is the TAG (Technical Advisory Group) and see if you can join the committee itself.

If you see an ISO standard that starts with the acronym ISO/DIS, you can get a copy.  This is useful for documents that have a major impact on your product or business.  You can review the proposed new edition and make comments (usually suggestions for improvement or criticisms of the content).  The committee is obliged to review your comments and take action on them in some way.

When an ISO committee has reviewed a ISO/DIS standard and has reconciled all issues, it then developes the final language for the proposed document.  This is the language that will be exactly used when the new edition is released, pending approval by ISO members.  Again, this ISO/FDIS is available for the general public to purchase.  It offers you an opportunity to look at the final language and start to make your transition plans.  However, it does NOT take the place of the eventual authorized edition when it is released.  So if you purchase a final draft, you will need to repurchase the same information in the form of the authorized edition when it’s available.

Now for a review of what will be different in the new 3rd Edition of the ISO 13485.  Annex A provides users of this standard with a comparison of the ISO 13485:2003 with this new ISO 13485:2016.   Significant changes have been made to the introductory material, expanding the influences on an organization’s QMS (Quality Management System) to include organizational environment and regulatory requirements.  This is part of an increased focus on the regulatory concerns in this new edition.

Reference to ISO 9001 now uses the new 2015 Edition of the quality standard.  Details are provided in Annex B, with some changes to how this material is referenced within the ISO 13485.  The scope of the standard is also expanded.  As you move throughout the publication, you’ll also see that requirements in many clauses have been expanded.  In the later clauses, there is also more attention to the issues raised by changes in how we view risk management for medical devices.

For me, another surprising addition to the ISO 13485 is the inclusion of the Z Annexes!  These tools for identifying what Essential Requirements are fulfilled by the use of specific clauses within the ISO standard have been solely used in EN adoptions.  We’ll see if this improves the clarity of EN requirements or if it creates issues with the New Approach Harmonized Standards system adopted by the European Union.

If you would like a copy of the Final Draft for ISO 13485, just remember you will need to purchase the authorized edition when it is released in 2016.  You can buy your copy on the Document Center website,  Here’s a direct link to the order page for the ISO/FDIS 13485.  It’s available in both paper format and for pdf download.  ISO 13485 can be included in your multi-user Standards Online subscription as well.

Still have questions? Contact our staff by phone (650-591-7600) or email (  We’ve been working with standards since 1982 and have the knowledge you need to understand and use these compliance documents.  Make Document Center your Standards Experts!