New AAMI TIR50 released for Use Error Detection

April 1st, 2014

With Medical Devices, minimizing risk for users and improving product safety and usability is paramount.  The new AAMI TIR50, “Post-market surveillance of use error management,” is geared to help anyone involved in the MedDev space learn how to best collect, review and act on post-market use error data to improve their products or processes.  It helps the reader develop a process for handling complaints based on usage errors of any kind.  Since these types of problems aren’t necessarily covered by regulatory requirements, this presents an opportunity for companies to improve customer satisfaction both short and long term.

What caused the interest in producing such a standard?  The FDA gets about 100,000 Medical Device Reports (MDR) annually.  Of those, one-third mention “error” in the filing.  Currently, there’s no clear data on what exactly all those “errors” are.  They may be user error of course.  But they might also stem from inadequate instructions or unclear markings on the devices themselves.  And AAMI was also concerned that there may be under-reporting issues due to the natural tendency to avoid a situation in which the party doing the reporting might risk being blamed in “near-miss” situations.

The Technical Information Report 50 guides you, the user, in developing a protocol and system for capturing use errors.  It describes process flow, training and scalability for your data capture and analysis efforts, including sample questions you might include in your database.

Interestingly enough, the Report approaches this issue from two distinct viewpoints — that of the manufacturer and that of the user.  This means that a clinician can find this document has helpful as a medical device manufacturer.  Why would the authors want to include both audiences?  Certainly both groups have a vested interested in assuring the proper use of medical devices, and in improving both processes and products to facilitate that goal.  So Section 7 of the document provides process recommendations for manufacturers while Section 8 covers the topic from the clinical perspective.

The document has 2 Annexes as well.  One covers suggested questions as I noted above.  The other has information that will help a manufacturer link customer complaints to usage errors.  This is intended to be part of your Usability Engineering effort, perhaps when designing a second generation product, or to forecast potential issues when designing a new product.  The Report is completed by a bibliography containing 19 citations to provide further reading on this topic.

Of course, you’ll need to get a copy of the new TIR50.  You can go to Document Center’s webstore, www.document-center.com, and order it in either paper format or for pdf download.  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  AAMI is an important contributor to the medical device standardization effort and Document Center is proud to be an authorized distributor of the AAMI publications.

New ASTM E18 2014 Edition released – Rockwell Hardness

March 31st, 2014

The popular ASTM E18, “Standard Test Methods for Rockwell Hardness of Metallic Materials,” has just been updated.  The new 2014 Edition is available from Document Center Inc. in either paper format or for pdf download.  The 38-page standard covers both the Rockwell Hardness and the Rockwell Superficial Hardness tests.  It includes both the requirements for the testing machines and the procedures for the tests themselves.

This new ASTM E18 2014 Edition cancels and replaces the previous 2012 Edition (I blogged on that edition when it was released.)  There are 10 notable changes to this update.  They are all contained in the Annex A3, Standardization of Rockwell Indenters (one of the mandatory Annexes):

  1. Section A3.4.5.1 was revised,
  2. Section 3.4.5.4 was revised,
  3. Section A3.5.3.2 was revised,
  4. Section A3.5.3.7 was revised,
  5. Section A3.8.2 was added,
  6. Section A3.8.3 was added,
  7. Section A3.9.1.6 was added,
  8. Section A3.9.3.6 was added,
  9. Table A3.4 was added, and
  10. Table A3.7 was added.

FYI: Section A3.4 covers ball identers, Section A3.5 covers Class B diamond indenters, Section A3.8 covers marking and Section A3.9 covers the certificate.  The new Table A3.4 addresses test blocks used for singular or limited scale ball indenter performance verification, plus maximum tolerances, for standardized reference blocks.  And the new Table A3.7 covers the same thing for Class A or reference indenter.

To get the complete details of all the updates to this new revision, purchase the redline edition.  You’ll get a copy of the new 2014 Edition plus a copy of the previous 2012 Edition with the changes all included and highlighted.  Ask about this when you place your order.

You’ll purchase your copy using our Document Center webstore, at www.document-center.com.  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing our customers with ASTM standards under license agreement since the 1980′s.  We’ll be able to assist you with any questions you may have about these documents.  And we’ll track them for you so you don’t have to worry about becoming non-compliant.  Make us your Standards Experts!

New BS EN 16309 supports sustainable construction in Europe

March 28th, 2014

Europe has been addressing many areas of it’s infrastructure in recent years, with regulation promoting green goals of reduction of hazardous materials, improved sustainability of products, and life-cycle requirements for goods sold there.  So it is no surprise that in 2011 the requirements for building materials and construction works were updated.  The new BS EN 16309, “Sustainability of construction works. Assessment of social performance of buildings. Calculation methodology,” is part of that effort.  It provides the specific methods and requirements for the assessment of the social performance of a building.  This covers the specific areas of accessibility, adaptability, health and comfort, impacts on the neighborhood, maintenance, and safety and security.

The standard is part of a series of documents on integrated building performance.  The areas that are being addressed by this series are environmental, social, economic, technical, and functional performance of buildings.  For each of these concept levels, there’s corresponding documentation to cover the framework level, building level and product level.

The environmental area has been completely “built out.”  And the BS EN 15643-1, BS EN 15643-2, BS EN 15643-3, and BS EN 15643-4 cover the framework level for environmental, social and economic categories.  So the BS EN 16309 is the assessment document that addresses social performance at the building level.

It applies to all types of buildings, both new and existing.  The standard gives requirements for:

  • the description of the object of assessment,
  • the system boundary that applies at the building level,
  • the list of indicators and procedures for the application of these indicators,
  • the presentation of the results in reporting and communication,
  • the data necessary for the application of the standard, and
  • verification.

It does not specify any particular valuation method.  You’ll be determining your own benchmarks or assessment goals based on national requirements, other regulatory codes and so on.  You’ll also note that corporate social responsibility issues are not addressed in this standard.  And the issues of sourcing of materials and services and stakeholder involvement that are included in the parent document BS EN 15643-3 have been left for a future revision.

If you need a copy of this new BS EN 16309 or any European standard, head to the Document Center webstore at www.document-center.com.  Or you’re welcome to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards since 1982, so we can assist you with all your documentation requirements.  Make us your Standards Experts!

New ISO 8600-4 2nd Edition for Endoscopes

March 27th, 2014

The ISO 8600-4, “Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion,” has just been revised.  The new 2nd Edition is available from Document Center in either paper format or for pdf download.  The document is one of 7 parts that comprise the ISO 8600 series on Endoscopes.  It updates the 1st Edition which was released in 1997 (and is now obsolete).

The endoscope is an essential tool in the medical device arsenal.  Simply defined, it’s a medical instrument for viewing that is inserted into a natural or surgically created body opening.  Used for examination, diagnosis or therapy itself, these devices usually consist of a rigid or flexible tube, a light source, a lens or video system to see or capture the image from the inserted end of the scope, and an additional channel to deliver medical instruments or manipulators.

It’s the Part 4 of the series that has just been updated, on the maximum width of the insertion portion of the endoscope.   The changes to the 8 page document involve combining the old sections 2 and 3 into a new section 2 on test conditions.  This means that the new edition is now laid out as follows:

  1. Scope
  2. Test conditions (includes test environments and the accuracy of measuring instruments)
  3. Methods of measurement (includes general overview, millimeter indication, and french size indication).

Figures 1 and 2 are still included.

Here’s a complete list of the standards in the series, as well as their issue dates so you can confirm you’ve got the latest editions:

  • ISO 8600-1, 2013 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements
  • ISO 8600-2, 2002 Edition, Optics and Optical Instruments – Medical Endoscopes and Endoscopic Accessories – Part 2: Particular Requirements for Rigid Bronchoscopes
  • ISO 8600-3, 1997 Edition with Amendment 1 from 2003, Optics and Optical Instruments — Medical Endoscopes and Endoscopic Accessories — Part 3: Determination of Field of View and Direction of View of Endoscopes With Optics
  • ISO 8600-4, 2014 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion
  • ISO 8600-5, 2005 Edition, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 5: Determination of Optical Resolution of Rigid Endoscopes With Optics
  • ISO 8600-6, 2005 Edition, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 6: Vocabulary
  • ISO 8600-7, 2012 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 7: Basic requirements for medical endoscopes of water-resistant type

Of course, if you need the any of the ISO 8600 series, you’ll want to purchase your copy from Document Center Inc.  You can do this at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  It’s essential that you discover those standards that could impact your business, and maintain those that you reference in your documentation.  That’s why we have a wide range of products and services to help you with this task.  We help many companies around the world with their standardization requirements.  Make us your Standards Experts!

New FDA Guidance for CLIA Categorization

March 26th, 2014

The FDA has just released a new guidance document, “Administrative Procedures for CLIA Categorization – Guidance for Industry and Food and Drug Administration Staff.”  It describes the classification system for clinical laboratories that accept tissues taken from people for diagnosis or treatment of disease.  It is geared for organizations that rely on those laboratories for FDA regulatory compliance, particularly for IVDs (in vitro devices).  This FDA Guidance for CLIA Categorization updates information on FDA administrative processes for the CLIA process, including the e-copy program which is voluntary for this situation.

CLIA testing is divided into 3 levels:  waived tests, moderately complex tests, and highly complex tests.  The FDA catagorizes the tests for a particular device when it is submitted for 501(k) or premarket approval.  At this point it is assigned a CLIA Record number (CR).  The particular level of complexity assigned by the FDA then means that any testing lab used must be cleared for tests at that level.

This guidance covers the process of assigning the CR number.  It also reviews what to do if your product does not need 501(k) or premarket approval, but is still covered by the CLIA requirements.  You’ll get a CR number too, and the protocol is included in this guidance.  It also has a section on the issue of waiver protocols and applications.

While the FDA guidance documents are not enforceable, they provide industry will a clearer understanding of the processes of FDA regulators.  And they can also clarify how the FDA views certain topics or issues that may affect your products.  If CLIA affects your business, you may also want to review the “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” from 2008.

The move to using electronic submissions for these types of activities has been prompted by the paperwork reduction act.  As the FDA discovers the benefits to staff in using online protocols and the benefits gained from the automatic database generation inherent in these systems, more processes are being moved online.

You can get the compliance information you need for FDA and other certification systems from Document Center Inc.  Try using our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been providing companies like yours with technical information since 1982.  Make us your Standards Experts!

New MIL-PRF-50884 Rev F replaces MIL-P-50884

March 25th, 2014

When it comes to the requirements for printed wiring boards for U.S. military usage, the MIL-PRF-50884 is an essential specification.  And the new Revision F, “Printed Wiring Board, Flexible or Rigid-Flex, General Specification for,” has just been released.  Previously numbered MIL-P-50884, the change in designation means the document is now classified as a performance specification.  The requirements are couched in terms of how the boards will perform, not on a detailed definition of how to produce them.

This spec was frequently referenced until it became inactive for new design in 1999.   The new revision remains inactive for new design — It is used exclusively for replacement purposes.  (Refer to MIL-PRF-31032 for new design.)  This new Revision F is a 136-page document, replacing MIL-P-50884 Revision E with Amendment 3 and all previous editions of that publication.  However, the good news is that it is not necessary to change any existing drawings that reference the older editions.

MIL-PRF-50884 is used for printed wiring boards, divided into 5 types as defined in IPC 2223 (replacing the obsolete MIL-STD-2118).   These boards are either Use A or Use B, supporting flexing either in installation or in use.  And they’ll be designated either grade R or grade U for rework.

The bulk of the document is actually the 8 Appendices (A through H.)  They cover:

  • Product assurance (performance and verification) requirements for QPL level
  • Product assurance requirements for QML level
  • C=0 sampling, test equipment and suitability of inspection facilities
  • Supersession and usage of current and legacy design standards
  • Qualification requirements for all levels of product assurance
  • External visual and dimensional illustrations
  • Metallographic illustrations
  • Quality conformance test circuitry.

Compliance with the new document is effective as of 9/15/2014.  This means that for contracts going forward, meeting the requirements of the new Revision F will be necessary.  In fact, if your product contains such printed boards as a component part, you’ll need to be assured that the boards you use meet these new requirements for any contracts you are awarded as well.

Changes are extensive, so they are not marked in the margins as is sometimes the case.

You’re able to get your copy of this new update from Document Center’s website at www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards since 1982, with much of our business supporting government contract work.  We have the documents and tools you need to procure and maintain your collection of compliance documentation.  Make us your Standards Experts!

New MIL-STD-883 Includes Revision J with Changes 1 and 2

March 24th, 2014

A new edition of the popular MIL-STD-883, “Microcircuits,” has been released and is available now from Document Center in either paper format or for pdf download.  The 759 page update includes Revision J plus Change Notices 1 and 2.  The new changes to the Test Method Standard are effective immediately, which means you need the new copy right away if you need to meet it’s requirements for any contracts you have.

I’ve blogged about the MIL-STD-883 before, since it is one of the most frequently ordered mil standards we sell.  So please review my blog on the new MIL-STD-883 Revision J and my blog on the new MIL-STD-883J with Change Notice 1 for more information on previous updates.

The change in this new release is minimal:  Method 2010 is changed.  Now in the test method “INTERNAL VISUAL (MONOLITHIC),” Section 3.1.1.1 for Metallization scratches, Paragraph h for Scratch (Probe Mark(s), etc.) the “or” has been changed to “and”, which means it requires a dual criteria for failure.

Back in the olden days, just a two page change notice would have been released.  The cover sheet would have summarized the changes, while a second page would have been available, either for pen-and-ink changes or as a reprint of the changed page itself meant to replace the original page.  (If you worked with Mil Standards back then, I’m sure you remember removing and replacing pages in various documents with some regularity.)

Now that the Mil Specs and Standards are all maintained as electronic documents, changes are issued as a complete corrected republication of the document.  Yes, this standard is 759 pages.  And the change on 1 page has resulted in the reissuing of the entire MIL-STD-883!

As long as we’re reviewing this MIL Standard, I also would like to mention the numbering system of the various test methods that are included in the document.  When you get the standard, you’ll notice that Test Method 2010 is now labelled “Method 2010.14″ and dated March 14, 2014.  In the previous edition (Revision J with Change Notice 1), the test method was labelled “Method 2010.13″ and dated June 7, 2013.  The Method 2010 is the number of the test method (in this case, INTERNAL VISUAL (MONOLITHIC)) and the .14 is the release number.

The other thing to remember about these test method standards is that each test method is numbered separately.  So the 1st page of test method 2010 is page 1, not 233 which is the actual page if calculated numerically with page 1 being the cover sheet.

If you need the latest edition of MIL-STD-883, you can use the Document Center webstore at www.document-center.com.  Or you can contact our sales staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll use us to purchase your mil specs and standards so you’ll be informed when changes to your documents are issued.  Face it,  there’s no other resource you can turn to for consistent information on changes like Document Center Inc.  The combination of our website features, our blogs and our notification and reporting services make it easy to use and maintain your conformance standards collections.  Make us your Standards Experts!

New ISO/IEC 17027 released for conformity assessment

March 21st, 2014

Terminology standards are some of the core documents leading to a uniform understanding of a particular topic or technology.  So the release of the new ISO/IEC 17027, “Conformity assessment – Vocabulary related to competence of persons used for certification of persons,” reveals the increasing importance of understanding the qualifications of auditors and other individuals involved in certification.

The new vocabulary standard was developed to support international documentation relating to the competence of persons, like ISO 9001, ISO/IEC 17021, and ISO/IEC 17024.  Since management standards are being developed at an increasingly frequent rate, it is not surprising that this fundamental issue of consistent definitions of terms has been at last addressed.

The new ISO/IEC 17027 will have applications beyond the use by ISO and IEC committees.  The development of defined terms will also be useful for those developing regulations, certification schemes, training and licensing services, and registrations.  The document has particularly included terms used to define the level of training an individual has attained, as  well as those terms that define what certification stands for, etc.

The document is a complement to the 3 ISO/IEC standards supporting certification services.  They are:

  • ISO/IEC 17021, Conformity assessment — Requirements for bodies providing audit and certification of management systems
  • ISO/IEC 17024, Conformity assessment – General requirements for bodies operating certification of persons
  • ISO/IEC 17030, Conformity Assessment – General Requirements for Third-Party Marks of Conformity

You can purchase your ISO and IEC standards from our Document Center webstore, www.document-center.com.  They are available in both paper format and for pdf download.  And you can purchase them as part of our custom collection subscription service as well!

If you would like more information on a particular standard or help placing an order, contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Document Center has been providing our customers with standards since 1982.  We have a range of services that support your use of standards.  Make us your Standards Experts!

New ISO/TR 18128 – Risk Assessment for Records

March 20th, 2014

There’s a new ISO technical report out that provides you with guidelines for assessing the risks associated with records generation and retention.  This new ISO/TR 18128, “Information and documentation – Risk assessment for records processes and systems,” helps those responsible for records management to review potential areas of uncertainty.  It covers any and all areas of an organization that create and store records of any kind.  So it is going to be helpful across the spectrum of your business activities.

You’ll use this technical report when you already know what records you need to generate and maintain.  It’s going to help you pinpoint the areas of vulnerability within your systems and to assess the potential impact of loss or damage to those records.  It is based on the concepts of ISO 31000 (“Risk Management – Principles and Guidelines”).  They are risk identification, risk analysis and risk evaluation.  Specific guidance is given that speaks directly to the challenges of protecting your valued data.

The clauses in 44-page ISO/TR 18128 cover the following areas:

  • How to identify specific risks related to records generation and maintenance.
  • How to analyze what effects various damage or loss scenarios might have on the organization.
  • How to conduct a formal assessment of these various risks.
  • How to document your risks prior to taking steps for mitigation.

You’ll not only get help due to the specific nature of the sources of risks that are covered, but also in evaluating how critical each might be to your situation.  In the wide-ranging review, issues as diverse as acts of nature to the introduction of errors due to human frailty to malware are all discussed.

And the 3 Annexes provide you with concrete assistance in the following areas: the format of entries in a risk register, checklists for identifying areas of uncertainty, and how to use the controls found in Annex A of ISO/IEC 27001 (“Information technology – Security techniques – Information security management systems – Requirements”.)

For many of our customers, the requirements of a good records management program are often times left up to the heads of the various departments.  This means that it is not unusual for the Document Center staff to get questions on how to appropriately handle essential records and maintain data collections.

If you need help with your records management system, you can search for and order the standards you need at our Document Center website, www.document-center.com.  For example, you can find similar standards to the ISO/TR 18128 at our page Document Center List of Standards on Information Sciences.  Or you can contact our sales staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

Since 1982, we’ve been assisting folks like you develop and maintain the engineering documentation so essential to your business processes.  We have programs that can make this task far easier and more reliable for your staff, improving your effectiveness without increasing your costs.  That’s why so many companies rely on Document Center.  Make us your Standards Experts too!

New MIL-DTL-55330 D describes packaging requirements for connectors

March 19th, 2014

I’ve often talked about the importance of correct packaging in government contract work, and the release of the new Revision D for MIL-DTL-55330 gives me another chance to make my case!  The specification, titled “Connectors, Electrical and Fiber Optic, Packaging of,” was originally numbered MIL-C-55330 when it was issued in 1971.  Due to Mil Spec reform in the 1990′s, the document was renumbered MIL-DTL-55330 with the release of Revision C in 2001.  This is the first update of the document since then.

MIL-DTL-55330 covers the requirements for packaging both electronic and fiber optic connectors for delivery to the U.S. government, particularly the U.S. military.  It describes how you will package connectors, mark those packages, and what tests you may be required to put the packages through in order to assure your government customer that the goods received will be in good working order.  You’ll also be given instructions on how to inspect your packages for quality control.

In addition, guidance is given to the government purchasing agent who will be referencing this document in contracts.  It is often helpful to understand what kind of requirements you may be responsible for.  So knowing the level of detail that should appear in your contract will be very useful to you.

You can expect to see the following information when reviewing acquisition requirements for delivery to your government customer:

  • Reference to a defined edition of this specification.
  • The levels of preservation and packaging required.
  • Quantity of unit pack if that quantity differs from this document.
  • The method of preservation if it is different than specified in this spec.
  • Whether or not a unitized load is required for shipment to a destination when the total quantities are equal to or greater than 40 cubic feet.
  • If any additional or special markings are required.
  • If it is necessary to include FED-STD-123 markings (for civil agencies).
  • If you’ll need to do special rough handling tests.
  • If you’ll need to do connector functional tests.
  • If there’s going to be any limitations on your responsibilities regarding the inspection requirements.
  • If first article inspection is NOT required.

The changes from the previous issue are extensive and not marked.  Of course, referenced documents MIL-STD-129 and MIL-STD-147 have recently been updated as well (see my blogs on the new issues of MIL-STD-129 and MIL-STD-147).  So this reflects the implementation of new processes throughout the logistics chain.

For your copies of military specs and standards, turn to Document Center Inc.  We’ve been providing our customers with these documents since 1982.  You can order on our website, www.document-center.com.  Or contact our sales staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

You’ll purchase your standards from Document Center because we support your use of these publications with a superior notification service.  We can also provide you with information on how to use the material more effectively — For example, we get questions regarding administrative protocols and contact points with regularity.

If you want a source for standards that helps you understand how to use these documents and that keeps you informed of changes, use Document Center.  We’re your Standards Experts!