AAMI TIR14 – Contract Sterilization

AAMI TIR14 for medical device contract sterilization has been updated.  The new 2016 Edition replaces the 2009 Edition, which is now obsolete.  The title for this new update is “Contract sterilization using ethylene oxide.”  It is one of AAMI’s technical information reports.

The AAMI TIR14 was developed to help medical manufacturers that use contract sterilization facilities or for those facilities themselves.  It is a companion to the ANSI/AAMI/ISO 11135.  As such it applies to ethylene oxide operations for devices marketed in the U.S.  Please note:  it does not address this type of sterilization in health care facilities like hospitals.

What’s covered in this new edition?  It has the usual scope and definition clauses to start.  Then information on how to choose a sterilization facility is provided.  You’ll get guidance on the written agreement that’s used between the product manufacturer and the contract facility.

Then the nuts and bolts of processing are covered.  This includes the validation program, handling of various samples, processing documentation and controls.  A 30-item bibliography completes the publication.

The new edition of the TIR14 was written in response to the release of the 2014 Edition of the ISO 11135 and it’s ANSI/AAMI adoption.  FYI:  The ANSI/AAMI/ISO 11135 2014 Edition is an FDA recognized consensus standard.  So, the additional guidance of the AAMI TIR14 can be very helpful in implementing this document.

If you are interested in purchasing a copy of the new Technical Information Report, choose Document Center Inc. as your supplier.  You can order at our webstore, www.document-center.com.  Your purchase will come with our best-in-class notification service at no additional charge.  Here is a link to the order page for AAMI TIR14 for your convenience.  Should you prefer, you can reach us by phone (650-591-7600) or email (info@document-center.com).

Of course, if you’re in the medical device industry, you’ve got a number of regulatory and compliance concerns.  For your standards requirements, Document Center has a wide range of products and services.  Many medical device manufacturers rely on Document Center to support their compliance efforts.  Make us your Standards Experts too!

ISO/IEC 29161 – The Internet of Things

How does the Internet of Things (IoT) actually work?  Look for standards “underneath the hood.”  The new ISO/IEC 29161 is a good example of how standards work behind the scenes.   This new document is titled “Information technology – Data structure – Unique identification for the Internet of Things.”  It uses existing and evolving data structures to set up a unique identification scheme for IoT.

This is a common problem when working with computer based systems.  When one thing needs to “communicate” with another thing, how does one “know” the other?  Because of this problem, unique identification schemes have been developed.  Many times these identifiers are based on the network location, like the URL.  However, “things” may also be identified with legacy data like serial numbers and rf tags.

So ISO/IEC 29161 provides you with information on the IoT Network.  It discusses unique identifiers used in these types of applications.  And it reviews various schema that are suitable for them.  Since there are a lot of standards that are being used in this space, there is definitely a need for some clarity.  The bibliography alone lists 78 relevant standards!

There are 4 informative Annexes in the ISO/IEC 29161.  Annex A is on how to use these types of unique identifiers with other IT standards.  Annex B has to do with sensor networks and “OID wrappers.”  (OID stands for Object Identifier.)  Annex C covers the identification schemes that can be used over a network.  And Annex D is on the ontology of identification.  (If this isn’t your field, I’m sure you’re wondering what the heck this means!  The concept of ontology comes from metaphysics.  It’s used in IT to mean a system that’s been set up for machine-interpretation in a particular domain.  Here’s an overview that makes the concept a little clearer:   Ontology Development 101.)

So when you’re thinking about getting an application that lets you turn your heater up 30 minutes before you get home, you’re using the ISO/IEC 29161 and all the other IoT standards!  And if this is your field, you’ll want to get a copy of this new publication.

All ISO and IEC standards need to be purchased from an authorized distributor like Document Center Inc.  You can search for and order standards at our webstore, www.document-center.com.  Here is a direct link to the order page for the ISO/IEC 29161.  If you have additional questions, please get in touch with our staff.  We can be reached by phone (650-591-7600) and by email (info@document-center.com).  Since we’ve been working with standards since 1982, we have the knowledge to help you with any standards question you may have.  Make us your Standards Experts!

New ISO 9626 2016 Edition

ISO 9626 has just been updated.  The standard is titled “Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods.”  The new 2nd Edition from 2016 replaces the 1st Edition from 1991 along with the Amendment 1 from 2001.  Both of the old documents are now obsolete.  The new update is a technical revision.

The stainless steel tubing in this standard is used in hypodermic needles and other medical devices.  I just posted on 2 other ISO hypodermic needle standards that have just been updated on Monday.  The ISO 9626 complements them because it specifies the dimensions and mechanical properties of the steel tubing they use.

It’s been a long time since this standard was revised.  If you use it, you’ll want to know what the changes are.  The ISO committee in charge has given you the following guide to the updates:

  • There are additional metric sizes in this standard for “greater comfort” when injecting (particularly for infants and toddlers)
  • More wall thicknesses have been added
  • Additional minimum inner diameters are included
  • The table of tubing dimensions and stiffnesses has been revised

If you remember the amendment 1 for the 1st Edition, the changes were highlighted by the use of bold font in that amendment.  However, since the 2nd Edition is a complete update, there are no clues to where the revisions are exactly.

If you use this standard you’ll need to get the new Edition.  Be sure to use an authorized ISO distributor like Document Center Inc. as your source.  You can search for and order standards at our webstore, www.document-center.com.  We have a long history of working with ISO and have all their standards available for you.  Here is a direct link to the order page for ISO 9626 for your convenience.

Many of our customers are looking for an enterprise wide solution.  Standards Online, our cloud based subscription service, allows you to make your critical compliance standards available to your entire organization.  Check in with our staff for more information.  We can be reached by phone (650-591-7600) or email (info@document-center.com).

Document Center Inc. stands out from the crowd when it comes to helping you manage your standards collection.  Make us your Standards Experts!

TL 9000 Release 6.0

TL 9000 Release 6.0, the QMS Requirements Handbook, will be available as of 9/16/2016.  This “Book 1” for telecommunications quality management systems will replace Release 5.5 from 2013.  You can pre-order your copy now from Document Center Inc.

What is the TL 9000 Quality Management Systems Requirements Handbook?  It is a guide for implementing a quality management system.  It parallels the ISO 9001.  It should be used by those in the ICT community.

Why has TL 9000 QMS Requirements Handbook been updated?  Primarily, the new Edition follows the updated format of the ISO 9001:2015 Edition.  Of course, the clarifications, modifications, deletions and additions specific to the Telecommunications Industry are included.

What will I find in the TL 9000 Requirements Handbook?  The document is divided into 10 sections.  They are: Introduction, structure, TL 9000 administration, context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.  In addition, you’ll find a glossary, bibliography, ISO 9000 defined terms, and administrative information on the publication and how it was developed.

Is the new version 6.0 available now?  No, it will be released in the middle of September.  Of course, you can always pre-order one or more copies right now by getting in touch with Document Center Inc.  We have provided our customers with a source for the TL 9000 documents since their inception.

Search for and order any standard at our webstore, www.document-center.com.  Here’s a direct link to the order page for the TL 9000 Requirements Handbook.  Should you have any additional questions or prefer to order in person, just contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

ISO Hypodermic Needle Standards Updated

Two ISO hypodermic needle standards have been updated.  They are ISO 6009 and ISO 7864.  I will review them separately below since these standards are widely used and contain technical updates.

ISO 6009, 4th Edition, Hypodermic needles for single use – Colour coding for identification

Hypodermic needles are given a color-code to provide a quick way to identify the outer diameter of a single-use needle.  ISO 6009 is the standard that allows manufacturers and users to correctly choose the color for each diameter.  This practice can be challenging for a manufacturer because the colors are often translucent.  Why?  So that air bubbles inside the hub can be seen and elimiated prior to injection.

The changes in this new edition can be found in the following areas:

  • Increased needle size range to include sizes down to 0.18 mm
  • Changes in the use of instrumental measurement of colors
  • Revisions to Annex A and the deletion of Annex B

ISO 7864, 4th Edition, Sterile hypodermic needles for single use – Requirements and test methods

These types of needles are used with syringes (6% Luer conical fittings).  They can be used to either inject or withdraw fluids into the body.   This is a broad-ranging standard.  It covers the needle itself as well as packaging, information to be included by the manufacturer, and so on.

Changes to this standard cover the following areas:

  • Expansion of the gauges
  • A new tapered needle designation
  • New references to the ISO 80369 series, ISO 15223-1, and ISO 23908
  • New Annexes on penetration force, for flow rate, and needle bonding strength
  • Updates to Annex B and Annex C

If you use either of these two ISO hypodermic needle standards, you’ll want to purchase your updates now.  Since both are technical updates, all previous editions are now obsolete (cancelled).

Purchasing standards and keeping up with the changes to the ones you own can be a challenge.  That’s why so many standards users choose Document Center Inc. as their source for compliance information.  Search for and order standards at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 6009 and to the order page for ISO 7864.  All standards purchases come with our “best-in-class” notification service.

If you’re looking for an enterprise solution, ask our staff about our Standards Online cloud service.  This subscription service provides your organization with 24/7/365 access to the standards you need.  Just check in with us by phone (650-591-7600) or email (info@document-center.com).  Make us your Standards Experts!

Are IETF Standards Free?

Are IETF Standards Free?  This is the third standards development model I am reviewing as part of my presentation at the SES (Society for Standards Professionals) Conference in Denver next week.  As SDOs (Standards Developing Organizations) consider distribution options, understanding models that do not charge users for standards is important.  And in my opinion, the IETF (Internet Engineering Task Force) model is the only one where standards are really free!

In this discussion, I will really simplify the IETF standards process in order to make my points.  But if you are interested in the organization, their mission, and their real standards development protocol, you need to take a look at two of their web pages.  The first is the “Getting Started in the IETF” page for newcomers to the IETF.  The second is the “The Tao of the IETF:  A Novice’s Guide to the Internet Engineering Task Force.”

The IETF is not a traditional standards developing organization.  It does not have dues and participation is free (except for attendance at any of the 3 annual meetings which do have a fee).  Documents generated by the IETF are called RFCs (Requests for Comments).  Some become standards, many don’t.

RFCs can be authored by a single individual or by a group.  Usually they are proposed within the structure of one of the many IETF working group.   Discussion may ensue, with commenting and revision being an essential part of the process.  A draft that has been through a number of updates may then be considered for adoption as an RFC.   Eventually, some RFCs are elevated to the status of BCPs (Best Current Practices) and some become Standards (STDs).  To learn more about this, take a look at RFC 2026,  “The Internet Standards Process – Revision 3.”

All RFCs are freely available on the Internet.  Of course, there are certain quirks that you need to be aware of.  An RFC that has been replaced with a newer revision will not have any indication that it is out-of-date.  You need to learn how the documents are kept and where to search in order to make sure you get the latest edition of a standard.

Also, you can imagine that over the years there have been plenty of attempts to create RFCs for topics that are of low interest to the community or attempts to derail Working Group projects.  So there are protocols in place to make sure that the IETF stays focused on areas where consensus is important to the development of the Internet.

There are some things to note when you look at the IETF, their publications, and their processes.  Because the group deals with the Internet, technology tools that make collaboration and consensus possible at a distance have been adopted by the IETF from the very beginning.  By relying heavily of open source tools and protocols, the group keeps costs to a minimum.

Also, since the work is highly technical in nature, participants really are “birds of a feather.”  And since all work is done on a volunteer basis, this usually means that only those directly involved with a particular aspect of Internet technology will be part of the appropriate working group.

How does this model differ from the traditional SDO protocol?  The constraints of “good standards development practices” as typlified by ANSI protocols make administration of the standards authoring process essential.  The IETF model does not meet ANSI requirements.  Right out of the gate, the need for due process, wide participation in authoring, and maintenance over the lifetime of the standard creates challenges the IETF does not have.  Traditional standards are expected to be reviewed once every 5 years.  Revision is often necessary.  All these things take money.

Are IETF Standards Free?  As you can see, the IETF RFC process and distribution practices are indeed without formal costs.  The IETF is an unusual and unique organization in the world of standards developers.  Yet this extraordinary model for consensus and documentation does offer other SDOs an opportunity to look at an entirely different way of operating.  Over time, there is no doubt that some of the IETF practices will be adopted by the traditional SDO community.

MEDDEV 2.7/1 Revision 4

MEDDEV 2.7/1 has been updated.  The document is titled “Clinical Evaluation: a Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC.”  While the new Revision 4 is a guideline, it does provide industry with specific information on how the Notified Bodies will be reviewing requirements for medical devices in Europe.  This is a complete rewrite of the Revision 3 from 2009.  And there still may be more changes to come once the new draft Medical Device Regulation (MDR) and in vitro Diagnostic Regulation (ivDR) are finalized.

You will want to carefully review the new MEDDEV 2.7/1.  Some areas that are impacted by the guidance are:

  • Usability – Evaluators will now review performance testing and data to support usability
  • Evaluation throughout the medical device lifecycle – “Sufficient clinical evidence” of conformity during the initial acceptance phase will be supported by on-going review during PMS (Post Market Surveillance).  PMS reviews will be scheduled based on risk factors and probably be more frequent.
  • Qualifications for evaluators are now more stringent.
  • Clinical evaluations will require proof that relevant essential requirements are being met.  Use Annex 7 for guidance on this.
  • Demonstration of “equivalence” has become more difficult.  For any device to use alternative compliance schemes in this way, documentation will be required to show all three general criteria (Clinical, Technical, Biological) are met.

It is expected that the impact of this new MEDDEV will be more clinical evaluations over the entire lifecycle of a device, more in-depth reviews of a number of factors including usability, more highly qualified evaluators, and more reports.  There is no information on when the Notified Bodies will begin exercising the new guidance in this publication.  So you may want to review it soon and then check in with the organization you use for EU Certification to determine how to best update your processes, etc.

With greater scrutiny of your product and the clinical evidence for it’s efficacy and safety, you can count on added costs.  Your first step will be to perform a gap analysis in order to get a handle on what lies ahead.  Luckily, this new publication offers you a lot of new material to help with this task.

If you need a copy, please use our webstore, www.document-center.com, to order now.  Here’s a direct link to the order page for MEDDEV 2.7/1 for your convenience.  Or get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  Here at Document Center Inc. our products and services help many in the medical device industry.  Make us your Standards Experts!

Are Consortium Standards Free?

Are Consortium Standards Free?  I’m looking at the broader issue of standards and public access for my presentation at the SES (the Society for Standards Professionals) Convention in Denver this month.  There are some standards that are made available for no charge.  I reviewed the Mil Specs and Standards set last week.  Today I’m going to take a look at Consortium Standards.

What is a Consortium?  Luckily, one of my co-panelists has a webpage with a detailed answer to this question: Consortium Info Essential Guide.  For our purposes today, let’s just say that a consortium is a group that has joined together to promote a specific technology or technological solution.  They often fast-track the development of standards in a particular area to provide the technical support to get a product or service to market quickly.

Why is a Consortium different that other Standards Developing Organizations (SDOs)?  The consortium process is often called “pay to play.”  That is, the standards system used is not particularly open in the classical standards sense.  It is a system based on the participation of a few key players.  These folks support the activities of the consortium with dues, often rather expensive in comparison with other SDOs.  They are interested in rapid consensus and deployment.  Their mission is to get their standard(s) in use as quickly as possible.

Are consortium standards provided at no charge?  Usually during the development process, consortium standards are not available.  This is primarily in the interests of time (and sometimes business interests as well).  Introducing additional players into the mix can end up in too much input, slowing down the process.  It may also give competing technology advocates a chance to see what is going on in a certain group.  Or give them a chance to derail the consortium’s goals.

However, once consortium standards are adopted and published by the group, they often are available at no charge.  This is to support the mission of the consortia — Wide adoption of the technology as a tool for promotion of the group’s products or solutions.  Let’s think of the original business strategy for the PC industry — Make PC standards open in comparison with Apple closed standards as a tool for increasing marketshare.

So consortium standards are not free — they do take money to develop, as do most of the standards we use.  However, by choosing to make the final publications available at no charge, a consortium is furthering its core mission — adoption of a specific technology.

What happens if a consortium standard is widely adopted?  How is the standard maintained?  This is an issue of standards development that presents a problem for many consortia.  The authoring group is brought together to get a technology adopted.  When it is, the group’s mission has been met.  Usually, at this point the consortium is dissolved.  But about the standard?

Much to the initial suprise of the traditional SDO community, it is at this point that many consortia hand over their publications to another standards organization.  IEEE has been the happy receipient of a number of standards developed by various consortia.  Why?  A traditional SDO is not only geared up to develop standards but also support them throughout their lifecycle.  For example, standards should be able to be revised if technical errors are discovered.  Standards should be reviewed once every 5 years.  Standards need to be distributed to a potentially large audience over a long span of time.  And even when cancelled, they still may be required for legal or regulatory purposes.

And when this transition takes place, does a consortium’s standard still get distributed at no charge?  Usually not.  While the costs for development are borne by the consortium’s organizers, the costs for maintenance are not.  So a traditional SDO who inherits this type of standard usually begins charging for it immediately.

The use of no-charge distribution of standards is a tactical choice for any consortia.  It is a tool to be used to achieve an end.  It can be very effective but does come with a price.  Many of the benefits of traditional standards development (open process, public review, and so on) are not available during the consortia process.  However, in exchange, a consortium will be able to gain consensus quickly, bring a standard to market in a timely fashion, and attempt to gain penetration of the market by open access to the document(s).

For a tranditional SDO, use of no charge distribution should also be considered a tactial choice.  It should be considered when issues of public interest and achievement of organizational goals make a strong business case and the costs of standardization can be covered by means other than standards sales.

Are MIL Specs and Standards Free?

Are MIL Specs and Standards free?  Should all standards be free?  How should we pay for the development and maintenance of standards?  These are some of the questions that I’ll be talking about at the SES (Society for Standards Professionals) convention in August.  As the standards community reflects on the impact of technology, questions about copyright are front and center.  It’s a basic Internet question:  Should information be free?

Let’s take a look at the DoD system of standards.   They are correctly referred to as public domain documents.  This means that they are not covered by the laws of copyright.  You can use them at no  charge but they are paid for by U.S. taxpayer dollars.  So to answer our question “Are MIL Specs and Standards Free?” we must say no, they are not free.  However, the costs are not borne by the user but by the public at large.

How has this  worked out?  Is this a model that industry should use?  Why was this system developed and what has it accomplished?

DoD specs and standards were developed to support the purchasing needs of the U.S. military.  Since government purchasing can have an impact on jurisdiction communities, it has to meet both practical and political needs.  It has spawned great successes and some well-documented failures.

Back in the day, I saw some shortcuts to good practices in the areas of authoring.  For example, one of our customers was requested to write a mil spec for an electrical component.  He added requirements that made his company the sole supplier for the item.  How could this happen?  The military standardization program just didn’t have enough resources to write all that documentation necessary in-house.  So on occasion it enlisted the help of the vendors themselves, with mixed results.

Other authoring and distribution challenges exist.  Finding appropriate tools for authoring and for conversion of legacy documents has been expensive.  The problems of providing paper copies have thankfully been resolved with the use of pdf delivery.  However, helping mil spec customers keep up with changes continues to be problematic.

Another issue created by this use of an exclusive set of documentation is certification.  In the past, visits to thousands of suppliers were needed to make sure products met the requirements.  Now with the adoption of the ISO 9001 requirements, third party certification has a place in the procurement system.

The development of a standards program specifically for government procurement did lead to purchasing scandals in the past.  Dr. Perry’s Mil spec reform in the 1990’s was an effort to reduce the DoD standards collection to a set comprised of military-only requirements.  For all widely available products, the military and other federal level purchasers moved to the use of industry standards.  So, much of the burden of cost of standardization is no longer paid for by taxpayers.  And now military purchasers have the ability to purchase goods in the open marketplace which saves even more millions of dollars.

The old DoD standardization program did have one shining benefit:  The standards set was widely used thoughout industry.  This penetration of the marketplace was an unintended side effect of the no charge availability of the documents to users.  When the DoD decided to cancel many of their publications during MIL Spec reform, it was a real blow to many standards users.  While most companies moved to industry specs, there is a significant number that stopped using standards altogether.

Of course, when it comes to standards, some developers are interested in fast adoption of a new technology.  In these cases, no charge distribution is a real plus.  But for many traditional standards developers, their documentation supports less “sexy” applications.  In these cases the funding for the transparent development and maintenance of their standards may be best achieved by selling the documents themselves.

The standardization community like other content creators will have to deal with many questions regarding copyright and the distribution of information moving forward.  Many of our common public issues like the promotion of trade, the health and safety of our population, environmental stewardship, and interconnectivity of products can be solved with the use of standards.  Finding a way to promote the use of proven solutions provided by standardization is one factor.  Finding a way to support the uncompromised development of this data is another.

ISO 5832-1 Surgical Implants

ISO 5832-1 has just been updated.  The standard is titled “Implants for surgery – Metallic materials – Part 1: Wrought stainless steel.”  It is the first part of a 12-item series on the topic.  The new 5th Edition cancels and replaces the previous 2007 4th Edition with it’s corrigendum from 2008 (correction sheet).  The new update is a technical revision.

Why use metallic materials specified in standards for surgical implants?  Of course, putting any foriegn substance into the human body will create reactions.  Metallic materials clearly specified in standards like ISO 5832-1 provide you with known levels of biological response.  These have been shown to be within an acceptable level  when used in appropriate applications.

Have you been using ASTM standards to define metallic materials used in your medical devices?  You will want to know that the ISO 5832-1 describes the same alloy (UNS S31672) that is referred to in the ASTM F138 and ASTM F139.  This is wrought 18Chromium-14Nickel-2.5Molybdenum stainless steel.  This type of steel was also referenced in the now obsolete DIN 17443.  One thing to note is that units of measurement in the ASTM standards are feet/inches while the ISO standard’s are metric of course.

While some organizations like ASTM do provide redline editions to help you spot the changes from one revision to another, ISO usually does not.  So there is no guidance from the source organization on where the changes have been made.  You will need to review the two documents side-by-side to see how the update will affect your processes.

However, because this update has technical changes, you’ll need a copy in order to be using best practices within your organization.  Choose an authorized distributor like Document Center Inc. in order to assure that you are meeting copyright requirements.  You can search for and order standards with confidence at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 5832-1 for your convenience.

Document Center Inc. can provide you with a wide array of additional compliance support.  Our various services are geared to keep your standards collection complete and correct.  Contact our staff by phone (650-591-7600) or email (info@document-center.com) to learn more about our notification, reporting, and online access products.  Make us your Standards Experts!