ASTM E1444/E1444M Updated!

ASTM E1444/E1444M, “Standard Practice for Magnetic Particle Testing,” has just been updated.  The new 2016 Edition replaces the previous 2012 Edition which is now obsolete.  And, as noted in my previous posts, the standard is the replacement for the obsolete MIL-STD-1949 (withdrawn in 1993).  It describes a particle testing method used to detect cracks and other dicontinuities on or near the surface of ferromagnetic materials (like iron, nickel and cobalt).

The ASTM E1444/E1444M can be used on materials in a wide variety of states.  It can be raw material, billets, finished material, welds and in-service parts.  It relies on the magnetic properties of ferromagnetic materials as the basis of the test.  You magnetize the area you want to test, apply prepared magnetic particles, and then monitor the resulting particle accumulations for your results.  The standard defines the basic parameters for controlling your application of the particles.  It does not tell you the procedure to use for your specific testing equipment.

While normally an ASTM committee will provide you with a guide to the areas of an update that have been revised, in this new 2016 Edition there is no such paragraph.  So you may want to purchase the redline edition in order to get both a clean copy of the 2016 update and a “marked-up” copy of the previous 2012 Edition showing the exact changes.

You’ll find revisions in the reference standards section, where a new ASTM recommended practice has been added to the list.  Section 5 has changes reflecting use of the new document.  And the quality control section has also been updated with the use of the added practice being referenced in a number of paragraphs.

Now to get your copy of this 22-page standard practice.  Use an authorized distributor like Document Center Inc.  You can search for and order ASTM standards at our webstore,  Here is a direct link to the order page for ASTM E1444/E1444M for your convenience.  And your purchase will come with our best-in-class notification service!

Want to order the redline edition?  Add this standard to a cloud-based enterprise access solution?  Get in touch with our staff by phone (650-591-7600) or email (  They can help you with all your questions and would be happy to get you started with our Standards Online subscription service.  We’ve been working with compliance documentation since 1982.  Make us your Standards Experts!

IEC TR 63039 Risk Analysis for Complex Systems

IEC TR 63036, “Probablistic risk analysis of technological systems – Estimation of final event rate at a given initial state,” has just been released.  It’s a highly technical guide to risk analysis for “electrotechnical items” — that is, systems composed of equipment that use electricity in some way.  So think of this as risk analysis for the Internet of Things, utilities, and so on.

Probablistic risk analysis is a partner to the concept of dependability.  It takes a look at possible negative outcomes and tries to provide guidance on both probability and severity.  IEC TR 63039 provides “a much simpler and realistic approach for probabilistic risk analyses compared to the conventional approaches, and will make it easier to cope with the risks of complex systems.”

So you will find lots of information in this technical report.  It defines both terms and concepts.  It reviews specifying various types of events (things that might happen).  It shows you how to classify event occurances.  It discusses various techniques (ETA, FTA, and Markov) to use, along with how to use various symbols and methods for graphical representation of these.  It suggests ways to both handle and estimate event frequency/rate for complex systems.  And it provides a number of examples to help you understand this process.

As noted, you’ll get a complete discussion of modern risk assessment tools including ETA (Event Tree Analysis), FTA (Fault Tree Analysis) and the Markov technique.  But, as with many technical engineering documents, reviewing concepts is only the beginning.  The report provides you with a wealth of equations to use to in determining such things as quantitative analysis of the occurance of a “final” event, the frequency and rate for repeatable events, and so on.  Many of these permutations of risk are also graphically illustrated by the use of various tables.

Over the last decade or so, the need for better analysis of risk with regards to our systems and infrastructure has become increasingly clear.  The IEC TR 63039 is a significant step forward in providing engineers with the tools necessary to define and rate these types of risk.  Only when we take a look at all possible outcomes for our systems, will we be prepared to handle both routine and extraordinary events.  If this is your field, you need this publication.

And you’ll want to purchase all your standards from a reputable source like Document Center Inc.  We’re a long-time distributor of the IEC standards.  Search for and order them at our webstore,  Here’s a direct link to the order page for IEC TR 63039 for your convenience.  It’s available in either paper format or for pdf download.

If you’d like enterprise-wide access to this or any standard, check in with our staff for more information on our Standards Online service.  You can reach us by phone (650-591-7600) or by email (  Our long experience with standards and the standards process makes us the ideal partner for compliance.  We’re your Standards Experts!

ISO 27799 Updated

ISO 27799, “Health informatics – Information security management in health using ISO/IEC 27002,” has just been updated.  The new 2nd Edition is a technical revision of the 1st Edition, so your copy of the older standard is now out-of-date (withdrawn and replaced by the 2nd Edition).  This important standard shows you how to protect the confidentiality, integrity and availability of personal health care information.  It should be used by those of you who are responsible for overseeing such information, especially with regards to security of this data.  This can include those of you in the roles of security advisors, consultants, auditors, vendors and other third part providers as well.

The ISO 27766 has been built upon the foundation provided by ISO/IEC 27002 (“Information technology – Security techniques – Code of practice for information security controls”).  But the 27766 particularly addresses those aspects of data security found in the health care environment.  Since healthcare records have the conflicting requirements for both patient confidentiality and for accessibility by a number of organizations, particular care needs to be taken.  And of course, record integrity is essential as well.

The ISO 27766 is a flexible standard, intended to be use in a variety of contexts.  The authors considered that many EHR (Electronic health record) implementations are made in situations where the health professional works as a solo health care provider or in a small clinic.  So the range of preferred security measures has been made scalable in order to give guidance in the many situations where this type of data is both generated and used.

It is a lengthy publication (112 pages in total).  It provides guidance on 14 security control clauses, 35 main security categories and 114 controls as specified in ISO/IEC 27002.  Attention is given to health-specific control, implementation guidance and other information.  These include information security policies, human resource security, access control, physical and environmental security and operations security.  Compliance and incident management are also addressed.  Three informative annexes are part of the document.  They cover threats to health information security, practical action plan for implementing security in healthcare, and a checklist for conformance to ISO 27799.  A 39-item bibliography completes the standard.

Now to get your copy of the new 2nd Edition.  You’ll use an authorized ISO distributor like Document Center Inc.  Head to our webstore to search for and order one of the over 1 million standards in our database.  Here’s a link to the order page for ISO 27799 for your convenience.

You may have additional questions or want to work with one of our staff members in order to place your order.  Feel free to contact us by phone (650-591-7600) or email ( with any standards issues you may have.  We’ve been working with standards since 1982.  So make us your Standards Experts!

CISPR 11 Amendment 1 Released

CISPR 11, “Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement,” has just been amended.  The Amendment 1 for the Edition 6.0 was released in June.  You have 2 options for your purchase — You can get the Amendment 1 as a standalone publication or you can get the Edition 6.0 with the Amendment 1 interfiled (called Edition 6.1).  Either way, you’ll be able to spot the updates, since the Edition 6.1 is a “redline” edition.  The changes are marked by the use of red (deleted) and green (added) text as well as lines in the margins.

CISPR 11 was developed due to the fact that ISM (Industrial, Scientific and Medical) equipment emits what is known as RF (radio frequency) noise.  This “disturbance” can affect other equipment in the vicinity, thus creating a hazard.  Certain frequencies have been designated by ITU (the International Telecommunication Union) for unrestricted radiation from this type of equipment.  Other frequencies have to be “controlled.”  The CISPR 11 contains specific requirements for the control of RF disturbances caused by ISM RF appolications.

What’s new in the Amendment 1 for the Edition 6.0?  It introduces the fully-anechoic room (FAR) for measurement of the disturbance field strength.   This is a shielded enclosure with the internal surfaces lined with RF energy absorbing material.  In particular, the new FAR requirements are for RF disturbance field strength in the range of 30 MHz to 1 GHz.

In the scenario now permitted, the FAR can be used for measurements of equipment that fits a validated test volume.  The separation distance must be 3 meters only.  The FAR can be used for measurements of table-top equipment.  And it must be validated according to the protocols of CISPR 16-1-4.   Other requirements are also included.

If you’re used to working with standards, you’ll know a change like this can affect many areas of a publication.  So there will be new definitions in section 3 and new or modified material in other sections as well.  Look for updates in Section 6, Section 7, Section 8, and in a number of the Tables.

You’ll choose the amendment only if you want to integrate the changes yourself.  Since only the updates are included, it’s a quick way to see exactly what’s been done.  However, using the interfiled Edition 6.1 means that when you open up your document, you’ll always have the complete and correct information at hand.  It’s your choice which way to go.

As IEC mandates, you’ll need to use an authorized IEC distributor like Document Center Inc. to purchase your CISPR publications.  Search for and order standards at our webstore,  Here is a quick link to the order page for CISPR 11 and one for the CISPR 11 Amendment 1 for your convenience.  Have more questions or prefer to work with one of our staff members?  Contact us directly by phone (650-591-7600) or email (  We’ve been selling standards since 1982.  Make us your Standards Experts!

ASTM E4 – Force Verification of Testing Machines

ASTM E4, “Standard Practices for Force Verification of Testing Machines,” has just been updated again!  I’ve blogged about this document a couple of times, as it is well-used throughout industry.  Here’s my post on the ASTM E4 2014 Edition.  This standard practice is updated regularly and is a good candidate for subscription access.  Be sure to ask our Document Center staff about this option when you place your order.

As I’ve stated before, the ASTM E4 provides you with the protocols, calibration requirements, and reporting data for what’s called force verification.  Force verification involves the use of a standard calibration device to check on tension or compression in your testing machine.  The process described here uses standard weights, equal-arm balances and standard weights, or elastic calibration devices.  You’ll be testing to see if the indicated force on your testing machine is within a permissible variation from the actual force of the test.

Every time a new revision is released, users want to know where the changes occur.  ASTM provides you with two aids in this regards:  Information at the end of many of the ASTM specs and standards provided by the committee and Redline editions.  Document Center Inc. can help you with both.

Certainly, in this new 2016 Edition, the major updates are in Sections 3 (Terminology) and 12 (now called Methods of Verification).  Additionally Note X2.5 has been updated (in Annex X2.)  Section 3 has been revised due to the inclusion of ASTM E6 in the referenced documents clause.  Sections 13 and 14 have been incorporated into Section 12 which accounts for the name change.  There are a number of other changes throughout the document as well.

In order to correctly catch all modifications to the document, again the Redline option is your best bet.  It costs a relatively small amount more, but offers you a better view of all the areas that may contain changes.  You’ll get a clean copy of the new standard as well as the marked-up (redline) copy of the previous edition.  Of course, it is up to you to verify all revisions since the redline is only provided as a tool and not an official ASTM document per se.

Now to get yourself a copy of the new update.  Search for and order any ASTM standard with confidence at the Document Center webstore,  Here is a direct link to the order page for  ASTM E4 for your convenience.  Document Center has been an authorized ASTM distributor since the 1980’s.

Should you have further questions, or need special assistance, just get in touch with our staff.  You can reach them by phone (650-591-7600) or email (  And why would I suggest using subscription access for this standard?  Since it gets revised frequently, using subscription access provides all members of your organization with access and updates are provided at no additional charge during the life of the subscription.  Just another reason to make Document Center Inc. your Standards Experts!

ISO/IEC 29146 – IT Security

ISO/IEC 29146 has just been released.  Titled “Information technology – Security techniques – A framework for access management,” it’s another in the on-going JTC 1 (Joint Technical Committee 1) publications on information technology (IT) security.  It’s used along with identity management to protect your organization from unauthorized access to your information resources.

You’re well versed in the IT security risk-based approach to managing security concerns.  You’ll use several security techniques in order to enforce the rules and policies you rely on to mitigate these challenges.  Right at the top of the list is access management.  How do you correctly identify both humans and machines that have the right to access you information resources?  After all, your information set may be distributed over a number of networks — both internal to your organization and external via internet access.  How can your protocols be standardized in this widespread environment?

ISO/IEC 29146 addresses the access management side of this problem.  ISO/IEC 24760 addresses the identity management component.  Together you’ll use them to define and establish your framework for the secure management of the use of your information assets.

The new standard provides you with an overview of the concepts you’ll want to be familiar with prior to setting up your system.  It then reviews the reference architecture used.  This includes the various components of an access management system — authentication endpoint, policy decision point, policy information point, and so on.  Additional requirements and concerns are also covered.  This includes various models and policy issues you may face, as well as regulatory requirements.

Clause 8 of the standard is titled “Practice.”   This section covers the actual processes involved in authorization and setting up privileges.  Treats are considered, as well as possible control objectives.  Methodologies for validation are included.  An informative Annex A provides you with a review of current access models.  A 17-item bibliography completes the 42 page publication.

ISO/IEC 29146 can offer your organization a framework for your access control system.  It describes the concepts, actors, components, reference architecture, functional requirements and practices you’ll need to understand and implement.  It is one of many security standards that we provide here at Document Center Inc.

To get a copy head to the Document Center webstore at  Here you can search for and order standards from our collection of over 1,000,000 unique publications.  Here’s a direct link to the order page for ISO/IEC 29146 for your convenience.  And if you have further questions or would prefer to order in person, just contact our staff by phone (650-591-7600) or email (  We’re your Standards Experts!


New In Vitro Diagnostic Devices Regulation (IVDR)

There’s a new In Vitro Diagnostic Devices Regulation (IVDR) on the way, likely to be complete at the end of the year or the beginning of next.  Then of course, there will be a time lag as the text of the revised European Union (EU) regulation is prepared for distribution.  For those of you in the MedDev business, this and the new Medical Devices Regulation (MDR) will definitely have an impact.  Let’s take a look at some of the probable areas where you can expect change.

For the medical device industry, standards and regulations go hand in hand.  This is especially true in the EU since a number of regulatory requirements can be met with the use of compliance to specific standards.  So this major revision of these EU regs will require some changes to the way you do business.

First, you’ll want to know that it’s expected that the definition of IVD MD will be expanded to include any device that is a reagent, a reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended to be used in vitro.  This is for diagnosis (predisposition to a disease, possible reactions to a treatment, any collection of blood and/or other tissue samples).  You’ll only be exempt if your products are for laboratory or research use, plus 3 other special cases.

The proposed new IVD Reg includes a new supply chain regime and expands the Eudamed database (to be renamed the MDR Eudamed).  FYI:  The MDR Eudamed identifier number is intended to aligned with the FDA UDI numbering scheme.  It’s expected that there will be perhaps 25,000 European manufacturers in the database, as well as a similar number located outside the EU.  Not only will new records be added, but old records will be retained.

Other regulatory changes for IVD include a ‘lifestyle tests’ extension when working with the concepts of purposes and prediction.  Also, IVDs will be evaluated by the risk classes developed by GHTF (Global Harmonization Task Force) instead of the current list-based system.  Only Class A (low risk) will be exempt from conformity assessment by a notified body (NB).  This change in the risk assessment means changes in conformity assessment as well.  Many IVDs that can be self certified will now need to be certified by an NB.  Estimations put the change from 20% of IVDs now to 80% needing 3rd party certification when the regs come into effect.

Lastly, clinical performance studies will be required to support the CE mark under the updated IVDR as it is currently being proposed.  What does this mean for you?  Likely you’ll need to product significantly more clinical evidence.  You’ll need to be able to prove scientific validity, as regulations move to making you fully responsible for the clinical utility of your IVDs.

When will compliance with the revised In Vitro Diagnotistic Devices Regulation be mandatory?  Unlike the new MDR with it’s probable 3 year transition period, there may be a 5 year “grace” period for you to make the migration from the old regulations to the new.  And of course, should the new MDR Eudamed prove a failure, the regulations to implement it will not be enforceable.

If you’d like additional help in monitoring the new directives and obtaining the supporting standards as they are released, please get in touch with us.  Here at Document Center Inc. we support many medical device manufacturers.  We have a range of services as well as standard sales all geared to improve your compliance for the various certification schemes your product must comply with.  Use our webstore,, for your purchases.  Or contact our staff by phone (650-591-7600) or email ( for additional assistance.  Make us your Standards Experts!

21 CFR – the FDA Regs

21 CFR – Understanding the FDA Regulations

Every year the 21 CFR for the Food and Drug Regulations gets updated.  Yet many of you who use the Code of Federal Regulations don’t understand exactly what they are, how they work and how they are modified.  We know many of our customers must meet one or more of the requirements of the various parts.  So having a clear understanding of the process and content is essential.

The CFR system was developed as part  of the reduction of paperwork act.  It is a resource that compiles all regulations from each of the executive department in one place.  It’s a lot of information, so it’s updated on a yearly basis, with a publication cycle that releases approximately one-fourth of the titles each quarter.

For the 21 CFR, the resource for the regulations issued by the FDA, the annual date is April 1.  This means that each April 1st all the FDA regulations that are in force are handed over for publication as part of title 21.  However, it takes a bit of time to actually push the material through the publication cycle.  The pdf format copy is usually available relatively quickly.  The paper format copy is usually released 3 to 4 months after the cut-off date.

The 21 CFR contains FDA regulations separated by Parts.  Each part is a regulation on a specific topic.  So for example, 21CFR Part 11 is on electronic records and electronic signatures.  Part 820 is on quality systems.  Since the 21 CFR comes as a 9 volume set, you’ll need to know which part you’re looking for in order to get the volume that includes that material you need.

One common question is “How do I know if the part I use has been updated?”  Since the 21 CFR volumes are released on an annual basis, you don’t know the answer by looking at the publication date.  You need to have the new volume in order to check this out.  For your part, you’ll look section by section through the regulation.  At the end of each portion, there are a series of dates.

The first date at the end of each section tells you when the regulation was originally enacted.  Then additional dates monitor the issuing of any modifications to the original text of the reg.  Specifically, these dates all refer to the publishing of the material in the Federal Register.  If the last date on this list is less than a year old, there has been a change to your requirements.

Since regulations are updated constantly throughout the year, only publishing them in the CFR’s is not appropriate.  Indeed, there are other protocols that need to be met in order to provide for the kind of regulatory activity that is allowed by law.  The true vehicle for this is the Federal Register.

The Federal Register is used for a number of purposes.  First, it announces regulations that are being considered for implementation by any given department.  This allows for the necessary public comment period required by law.  Secondly, it is the official publication vehicle for the announcement of the adoption of any given regulation.  This can happen any time throughout the year.  And thirdly, agencies like the FDA use the Federal Register to announce workshops and other activities of interest to the general public.

Since all agencies use the Federal Register, it can be overwhelming to try to follow any specific piece of rule-making or the regulations released to enforce a particular piece of legislation.  This means that the CFR’s have a real role to play.  They give U.S. citizens a place to review this material by topic and source, not by date.

Of course, keeping up with an agency like the FDA is more complex that just following the 21 CFR’s each year.  You may have specific issues that can be helped by using the FDA Guidance Documents or other tools.  That’s why Document Center Inc. carries a wide variety of publications from many of the Federal Level agencies.

If you have questions about this, please get in touch with us.  Document Center has been working with government publications and a wide spectrum of standards since 1982.  You can reach us by phone (650-591-7600) or email (  Our webstore is located at  We provide you with a resource for compliance documentation requirements and questions.  Make Document Center Inc. your Standards Experts!

AMS 5662, AMS 5663 and AMS 5666 – Nickel Alloy Specs

AMS 5662, AMS 5663 and AMS 5666 have all been updated!  The new revisions for these nickel alloy material specs are here now at Document Center Inc.  The specifications cover corrosion and heat-resistant nickel alloy in specified forms.  Each of the 3 new revisions stems from the usual SAE 5 year review.  Similar areas in each of these materials specifications are addressed in the updates.  Let’s take a look at each separately for a complete run-down of the changes.

AMS 5662, Revision N, “Nickel Alloy, Corrosion and Heat-Resistant, Bars, Forgings, and Rings 52.5Ni – 19Cr – 3.0Mo – 5.1Cb (Nb) – 0.90Ti – 0.50AI – 18Fe Consumable Electrode or Vacuum Induction Melted 1775 °F (968 °C) Solution Heat Treated, Precipitation-Hardenable.”

This type of nickel alloy (similar to UNS 07718) is used in applications where high resistance to creep and stress-rupture are required.  The alloy is often formed or welded prior to precipitation heat treating.   The following clauses have been modified:  Table 1 (composition), (condition), 3.5 — Tables 2 and 3 (properteries) and 4.4 (reports).  Properties for product that have a diameter of 5 to 10 inches are added.  Conformance to AS-6279 in clause 4.4 is also added.

AMS 5663, Revision N, “Nickel Alloy, Corrosion and Heat-Resistant, Bars, Forgings, and Rings 52.5Ni – 19Cr – 3.0Mo – 5.1Cb (Nb) – 0.90Ti – 0.50Al – 18Fe Consumable Electrode or Vacuum Induction Melted 1775 °F (968 °C) Solution and Precipitation Heat Treated.”

Again, this type of nickel alloy is similar to UNS 07718.  It’s used for parts that need to be resistant to creep and stress-rupture as well.  Changes are to the same topics, but sometimes in clauses whose numbers differ from the AMS 5662.  So you’ll find changes to Composition (Table 1), Condition (3.3), Properties (3.5, Tables 2 aand 3) and Reports (4.4).  Additions are again, properies for product with a diameter of up to 10 inches and conformance to AS-6279 (in clause 3.8).

AMS 5666, Revision H, “Nickel Alloy, Corrosion and Heat-Resistant, Bars, Forgings, Extrusions, and Rings 62Ni – 21.5Cr – 9.0Mo – 3.65Cb (Nb) Annealed.”

As before, this nickel alloy specification has been updated due to the usual 5 year review.  The nickel in question can handle higher temperatures for both corrosion and oxidation resistance.  The material is similar in composition to UNS N06625.  Your updates will be found in the following sections:  Composistion (Table 1), Condition (, Tensile properties ( — Table 2), Grain size (, Sampling and testing ( and Reports (4.4).  Again, there is the addition of properties for product up to 10 inches in diameter.  And again, conformance to AS-6279 is added in clause 3.6.

For those of you who use these specifications (and many of you do!), these updates are a must.  Order them at the Document Center webstore,  Here’s a direct link for the order page for AMS 5662, for AMS 5663, and for AMS 5666.  Or you are welcome to contact our staff for assistance.  We can be reached by phone (650-591-7600) or email (

Some of you may remember that SAE standards used a DRM product that was difficult to install and use successfully.  You’ll be glad to know that the SAE standards from Document Center Inc. are no longer tethered to that product.  They are as easy to use as any of the other pdf format standards we carry.

And don’t forget — When you purchase these documents or any other standard from Document Center, you’ll get our best-in-class notification service free with your order.  It’s another reason to make us your Standards Experts!

Brexit and BS EN Standards

Now that we’re all getting used to the idea that the U.K. has voted to leave the European Union, what about the Brexit and BS EN Standards?  Does the Brexit affect Britian’s participation in CEN and CENELEC and the publishing of the BS EN documents?  Will BSI continue to act as a notified body?  Will it continue to be able to certify your organization’s products for sale within the EU?  Does this rejection of the regulatory burdens placed upon the U.K. by the EU affect British standards making?

For those of you who have referenced BS EN standards in your product documentation, you can breathe a sigh of relief.  While there will be some changes, the U.K. will remain within the CEN and CENELEC standards making process.  BSI should continue to adopt and distribute the BS EN standards.  And should their status as a notified body be withdrawn, they will surely find a notified body that they can represent in order to continue their certification activities.

How can this be?  Doesn’t the Brexit mean that the U.K. will not be a part of the European Union any longer?  Actually, there are several non-EU countries already participating in both CEN and CENELEC.  These include Iceland, Norway and Switzerland as well as candidate countries Macedonia and Turkey.  This is done by way of particiation in the European Free Trade Association (EFTA).  There is no suggestion as yet that the U.K. would pull out of this group.

There will be one notable result of leaving the EU for Britian:  It won’t be involved in the formal discussions in CEN and/or CENELEC on the needs of the EU with regards to any specific standard.  It will also be out of any discussions about mandates or decisions about harmonized standards.

So while Britians may be thinking that the Brexit vote will reduce the regulatory burden, this will be true only to a limited extent where goods and trade is concerned.  Part of the requirements that accompany national participation in CEN and CENELEC mandates adoption by a specific date.  They also dictate that duplicating or conflicting national standards be withdrawn by a specific date.  So while certain domestic regulation will again revert to the nation, much of the overhead of compliance with EU Directives and the Harmonized Standards system will remain.

Should you be concerned or want to use EN standards from an alternative European source, please get in touch with us.  Here at Document Center Inc. we have a number of options for you with regards to your EN standards.  Take a look by searching for standards at our webstore,  Or contact our staff by phone (650-591-7600) or email (  We’ve been working with standards since 1982.  Make us your Standards Experts!