AAMI TIR35 – Medical Device sterilization

AAMI-TIR35, “Sterilization of health care products – Radiation sterilization – Alternative sampling plans for verification dose experiments and sterilization dose audits,” has just been updated.  This is a technical information report.  It is different from an AAMI standard.  It is released due to the immediate need within the medical device industry.

The AAMI TIR35 should be used in conjunction with the ANSI/AAMI/ISO 11137 series.  It describes how the number of items used as a sample for establishing and maintaining the sterilization dose can be reduced from the 100 items required in Methods 1 and 2 of ANSI/AAMI/ISO 11137-2.  The method in TIR35 is statistically equivalent to that of the 11137-2.

Another  area where the AAMI TIR35 provides guidance is for accepting new or redesigned products into an established product family using a technical evaluation.  You’ll use the TIR35 to determine what method you’ll use in order to do this.

FYI:  The TIR35 was adopted from the ANSI/AAMI/ISO 15843, 2000 Edition.  That document is now obsolete, having been replaced by the TIR35.

Since the 2006 Edition of TIR35 is now withdrawn, you’ll need the new 2016 Edition if you use this publication.  Get your copy from Document Center Inc., an authorized distributor of the AAMI standards.  You can search for and order these documents at our webstore, www.document-center.com.  Here’s a direct link to the order page for AAMI TIR35 for your convenience.

If you need more help, just get in touch with our staff.  You can reach us by phone (650-591-7600) or by email (info@document-center.com).  We’ve been selling standards since 1982.  Make us your Standards Experts!

NFPA 232

NFPA 232 for the protection of records from fire hazards has been updated.  The new 2017 Edition is available from Document Center Inc. now.  It replaces all previous issues including the former 2012 Edition.  The title is “Standard for the Protection of Records.”  It is 48 pages long.

Protecting vital business records is an essential part of every disaster plan.  NFPA (the National Fire Protection Association) reminds us that even in fire resistant buildings, valuable documents can be at risk.  That’s why the NFPA 232 was developed — to help you set up proper facilities and processes for protecting your essential records.

NFPA 232 “presents the latest requirements for records protection equipment and facilities and records-handling techniques that safeguard records in a variety of media forms from the hazards of fire.”  It has been extended over the years to refer not only to paper documents, but also records in a wide variety of media.

There are a number of changes in the new 2017 Edition.  These include:

  • Guidance specifically on the protection of electronic media, including a new reference to the NFPA 75 on the protection of IT equipment.
  • New subcatagory definitions for such things as record medium, record type, and record status.
  • “Fire resistance” has been replaced with the term “fire resistance rating.”

NFPA suggests that you need a copy if you are an engineer, AHJ, facility manager, insurance company, or manufacturer.  So consider ordering your copy of this new revision from Document Center Inc. today.  You can order the publication in either paper format or for pdf download at our webstore, www.document-center.com.  Here is a direct link to the order page for NFPA-232.

If you prefer, you can get in touch with our staff directly, either by phone (650-591-7600) or by email (info@document-center.com).  We’ve been working with standards since 1982 and have a wide variety of products and services to help you.  Make us your Standards Experts!

IEC TS 62668-2 Updated

IEC TS 62668-2 has just been updated.  The title of this technical specification is “Process management for avionics – Counterfeit prevention – Part 2: Managing electronic components from non-franchised sources.”  It is Edition 2.0 and replaces Edition 1.0 which is now obsolete.  It is an essential document for all those in the avionics industry tasked with verification of the supply chain.

Why is it essential for avionics companies to not use counterfeit parts?  This industry has set a high bar when it comes to its responsibility for public safety.  This has been achieved in part by the rigorous use of risk management, including predicted product life.   With accurate estimations of when various parts should be replaced or repaired, such high levels of performance can be achieved.

However, non-conforming components introduce unacceptable levels of risk into the equation.  There is no understanding of how long the useful life of these recycled, counterfeit or fraudulent parts may be.  So how can operational functionality be estimated?  You can see it is essential that such components not be introduced into the supply chain in the aerospace, defense and high performance industries.

IEC TS 62668-2 is an essential part of any organization’s campaign to preserve the integrity of it’s component parts.  It is specifically used in situations where components must be purchased outside the usual OCM (original component manufacturer) or franchised distributor networks.  It is a complement to the IEC TS 62668-1 which covers normal supply channels.

If you’re using this document already, you’ll be getting a copy of the new edition so you can stay current with this publication.  You’ll want to know that there are a number of significant updates to the technical specification.  The committee points out the following revisions:

  • The risk assessment process has been updated
  • The test methods have been updated, including a new reference to SAE AS-6171
  • Harmonization with updates to the IEC TS 62668-1 have been made, including definitions, references to DFARS (the federal acquision requirements for the Department of Defense), and the removal of the reference to RECS (Reliable Electronic Component Supplier).

Now to get a copy of the new Edition 2.  Choose an authorized distributor like Document Center Inc. for your purchase.  You can search for and order standards at our webstore, www.document-center.com.  Here is a direct link to the order page for IEC TS 62668-2 for your convenience.  You may order it in paper format or for pdf download.

If you would prefer corporate cloud access, just check in with our staff and ask us about our Standards Online subscription service.  You can reach us by phone (650-591-7600) or by email (info@document-center.com).  We can assist you with a variety of services all geared to help you stay compliant.  Make us your Standards Experts!

ISO/TR 14073 – Your Water Footprint

ISO/TR 14073 has just been released.  It’s titled “Environmental management – Water footprint – Illustrative examples on how to apply ISO 14046.”  You’ll use this to help your organization define your “water footprint!”

So first we need to define “water footprint.”  This is the metric(s) that quantifies your potential environmental impacts related to water.  The ISO 14046 provides you with the principles, requirements and guidelines of any of the ISO environmental management systems.  It is used specifically for the assessment of your “water footprint.”  And it can be part of a life cycle assessment program.

As with any new management system standard, there are still questions about how to implement your program.  The ISO/TR 14073 provides you with examples that can help you make the various choices needed during your assessment phase.  This is a rapidly developing field.  Your standards developing organizations intend for this technical report to facilitate widespread application of this process.

How many examples are given in the ISO/TR 14073?  There are 18 separate examples included in this publication.  They cover such varied situations as agriculture (rice production), energy (power plants), manufacturing (textiles), municipal water management, hotel and water reservoir operations.  Goal and scope, inventory, impact assessment and interpretation are reviewed for each.  Additional issues discussed in this publication include seasonality, use of a base line, evaporation, water quality, and so on.  A 43-item bibliography completes the document.

Many organizations are looking for ways to both measure and manage their environmental impacts.  Water remains a top concern for many of these entitities.  Use of both the ISO 14046 and the ISO/TR 14073 can only improve the performance of these organizations in gaining control over their impact on the communities in which they operate.

To get copies of these standards, you’ll use 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 ISO/TR 14073 and to the order page for ISO 14046.

Should you want to set up online access for your organization’s compliance documentation set, contact our staff.  They’ll be happy to provide you with more information on our Standards Online cloud-based service.  You can reach us by phone (650-591-7600) and by email (info@document-center.com).  Make us your Standards Experts!

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.