ISO/IEC 20006-2 extends IT Learning Information Model

ISO/IEC 20006-2, “Information technology for learning, education and training – Information model for competency – Part 2: Proficiency level information model,” has just been released.  The ISO/IEC 20006 series is intended to be used by software developers, implementers, and architects of human resources systems and learning systems.  The second of the three-part series provides users with an information model for exchange of data on proficiency.  Use cases provide additional support.

The use of IT for learning and human resources is on the rise.  For companies, it’s reflective of the rapid pace of change in so many industries.  For academic settings, it’s a factor of cost-reduction.  This is leading to an explosion in SaaS solutions for both learning itself and human resources staff development and record-keeping.

One element of such programs is the interchange of information.  And among the information elements is proficiency or competency.  Your staff has taken an e-course to update their skill set.  At the end of the course, they proved that they digested the material by passing a test.  What information about that do you need to keep and perhaps move from one system in your company to another?

Elements of competency include data on the action (training), who (the actor), what (the competency or skill), where (environment – to include location, duration, date and time), how (the method of measurement), , the trainer (school, university, etc.), outcome (level of proficiency), and then like.  The ISO/IEC 20006 series answers the question: “How should you represent these elements within an IT system?”  Part 2 focuses specifically on the identification and data elements for proficiency itself.

Since I am not a technical person, I grant you that a standard with this degree of technical information can be a challenge to review!  However, it is clear that this is the document for those who need to categorize and label such information units and exchange them successfully between differing systems.  First you’ll get a firm grounding in the relevant terms and relationships.  Then the ISO/IEC 20006-2 covers proficiency level information modelling in depth.  You’ll get the details on the proficiency composition model, the proficiency information model, and the level information model.  Annex A covers the application to the EQF (European Qualifications Framework).  Annex B does the same for the ITSS (Japanese National Skills Standard).   A 4-item bibliography completes the document.

What’s next for the ISO/IEC 20006 series?  The ISO/IEC 20006-3, “Information technology for learning, education and training — Information model for competency — Part 3: Guidelines for the aggregation of competency information and data,” is in the works.  The target publication date is for 2015, so we will see…

ISO and IEC remind you to get your copies of these standards from an authorized dealer.  Document Center  Inc. has been selling these standards under license agreement since the 1990’s.  You can find the documents you need at our webstore, www.document-center.com.  You will be able to order the ISO/IEC 20006-3 in both paper format or for pdf download.  And if you’d prefer to get the document as part of a multi-user subscription, ask our staff about our Standards Online service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Make us your Standards Experts!

New IEC 62014-5 — Adopts IEEE 1734

There’s a new IEC 62014-5, “Quality of Electronic and Software Intellectual Property Used in System and System on Chip (SoC) Designs.”  This new Edition 1.0 actually adopts IEEE 1734 of the same title that was released in 2011.  And the IEC edition has now been adopted itself in the European Union under the number EN 62014-5.  I’m mulling over submitting a paper to the World Standards Day competition — and the theme for World Standards Day this year is “Standards – The World’s Common Language.”  It makes me wonder, are we creating one common language or a tower of babel?

Let’s talk about the document itself and it’s origins.  From 1996 to 2008, the VSI Alliance — a consortium of companies in the System-on-Chip (SoC) industry — developed a series of standards for virtual components.  The purpose of the group was to provide ” leading edge commercial and technical solutions and insight into the development, integration, and reuse of IP.”  The Alliance developed developed the VSIA-QIP v4.0 spreadsheet and macros, and the QIP Metric Users Guide Version 4.0 document. Some of this material then made it’s way into the IEEE 1734.  This is not an unusual occurrence, since many consortia hand off their documents to other organizations when they feel that they have achieved their goals and decide to disband.  And it is not unusual for the new caretaker to renumber the publication, at least the initial acronym if not the entire reference number.

Your IEEE 1734 document provides users with a standard XML format for representing electronic design intellectual property (IP) quality information.  This is basically a reusable collection of design specifications.  The QIP then stands for Quality (electronic design) Intellectual Property and is integral to this document.  It is a set of rules that allow the user to class products as QIP compliant.  The standard first explains the fundamentals of using these rules and then provides you with the actual XML tagging needed for compliance.

Fast forward from 2011 to 2015.  Now IEEE and IEC are working together to integrate many of the IEEE standards into the IEC data set.  We find co-numbered documents released for nanotechnology, design automation, instrumentation, etc.  These standards are IEEE documents that are then submitted to IEC for inclusion as IEC publications.

However, when these IEEE standards make the move to IEC, they are given new IEC numbers.  So we now have two documents living side by side, with the same internal content but with two different numbers.  You’ll see this phenomena in some U.S. military publications, where different branches of the military co-number a document with a numbering scheme from each (an example?  A recent publication on Ophthalmic Services is co-numbered Army Regulation AR 40-63, SECNAVINST 6810.1, and AFI 44–117).  This co-numbering structure is also to be found in the IEC adoption of the IEEE 1734.  The new edition cover sheet has first IEC 62014-5, Edition 1.0, 2015-03, and then IEEE Std 1734™-2011.

OK.  We can deal with co-numbering now that we understand how it happens.  But wait!  The European Union decides to adopt the IEC publication.  Yes, now there is an EN 62014-5 that has been released for use in the EU.  And, as with all EN documents, it is only available in the national editions.  So you will find BS EN 62014-5 now available, with other national reprints soon to follow no doubt.

What do you think?  Because the same source material is now officially adopted in a wider number of jurisdictions, are we moving towards a common language?  Or because of the proliferation of document numbers for the same core material, are we heading for a kind of babel-mania?  I’d welcome your comments!

Meantime, if you do need to get any of these standards, please choose Document Center Inc. as your preferred supplier.  We’re at www.document-center.com and can help you with purchasing and maintaining your standards collection.

IEC TR 60601-4-3 Released – Recommendations for IEC 60601-1

IEC TR 60601-4-3, “Medical electrical equipment – Part 4-3: Guidance and interpretation – Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements,” has just been released.  This new Technical Report provides the user with insight into areas in the existing edition of IEC 60601-1 that expert users feel need to be updated.  For manufacturers of medical electrical equipment, the testing labs they use, and the developers of the next edition of the IEC 60601-1 standard, this represents an early review of questions on interpretation that have come up and the working group’s recommendations for each.

This is a lengthy document, numbering 100 pages, with tabular information for 93 recommendations.  Each item is presented in the same format, a grid with the following fields on the left and the committee’s data on the right:

  • Recommendation number
  • Requirement, clause/subclause numbering from the IEC 60601-1
  • Source/problem as submitted to the working group (WG 14)
  • Discussion/comment from the submitter of the initial question
  • Submitter proposed recommendation when available
  • The working group final recommendation

Annex A provides you with a table that is sorted by the IEC 60601-1 clauses in numerical order, so that you can easily find any recommendations for a specific clause in the original document.  A 5-page bibliography completes the report.  It looks like only Clauses 1, 6, and 12 have managed to squeak by without suggested changes!

Why would you care about these recommendations?  One critical issue for medical electrical equipment manufacturers is meeting new requirements within the “grace period” for transitioning from one edition of a standard to the next.  Gap analysis can be extensive and changes to products, assembly lines, and required tests take time.  A document like the IEC TR 60601-4-3 provides you with a preliminary review of the areas where changes are possible and the likely outcomes.  Further, if there are recommendations that you feel are not “best practices,” you now have time to contact the TAG (technical advisory group) in your country that participates in the development of the IEC 60601-1 with your concerns.  This is a proactive stance that has come to be known as strategic standardization.

Meantime, you’ll want to get a copy of IEC TR 60601-4-3 from an authorized distributor and Document Center Inc. is your answer!  Head to our webstore at www.document-center.com and order online in both paper and pdf format.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) to learn more about our Standards Online multi-user subscription service.  We have the tools for you to use to manage your standards in a cost-effective and compliant way.  Make us your Standards Experts!

Harmonized Standards and Presumption of Conformity

Since the inception of the “New Approach” back in 1985, the key concepts of the use of Harmonized Standards and Presumption of Conformity have provided medical device vendors with a valuable tool in meeting legislative and regulatory requirements in the EU.  But over the last few years, the addition of the Z Annexes to many of these documents have certainly caused many of Document Center’s clients headaches!  So I thought that a little review of the New Approach, Harmonized Standards and Presumption of Conformity might be in order.

The New Approach was developed to assist Europe develop a common market.  It makes use of standardization as a tool for creating common requirements within the group of nations that make up the EU.  It relies on legislation to mandate performance levels and a standardization scheme to provide a path to meeting those performance levels.  This use of a body of standards (your harmonized list) to fulfill legislative mandates is know as the presumption of conformance.

Of course, use of the harmonized standards is not the only path to conformance.  A company can choose another solution if they prefer.  However, they will need to “make their case” for conformance in a way that is not necessary had they decided to meet the requirements of specific harmonized standards instead.

Why have standards on the harmonized list for medical devices run into so many issues with the intended “presumption of conformity?”  The Medical Device Directive, The Active Implantable Medical Device Directive and the In Vitro Diagnostic Medical Device Directive all have articles that in some cases are not strictly met by clauses in the corresponding standards adopted from ISO and IEC.  These gaps may be spotted by a review of the Annex Z’s in the documents in question.

These Annexes match legislative mandates to specific clauses within a particular standard.  Where there are discrepancies, this is noted.  Additionally, certain standards may not address all the requirements of the legislation, but only particular articles.

During the last couple of years, as certification has raised flags regarding the correlation between the legislative requirements and the reality of the harmonized standards, these Annex Z’s have been undergoing changes.  And since the changes reflex a degree of compliance to the legislation that was not considered practicable when the standards were first developed, you can see that there’s going to be an issue raised for many medical device manufacturers.

Of course, standards do represent “state-of-the-art” in many cases.  However, with increasing concerns about risk assessment, etc., the use of the medical device harmonized standards no longer confer the degree of conformance as they once did.

When will this issue crop up for you?  You will have to address it when a new edition of one of the standards on the harmonized list is updated.  The “date of cessation of presumption of conformity” will be your target date for compliance.  That is, you will need to have moved from the old edition to the new by that date on the harmonized list publication.  Any device already placed on the market in Europe by that date will not be affected.  However, any device sold after that date will need to meet the new update.

What is required to make the move from one edition to another?  You will need to confirm that your product’s “justifications” for conformity are valid using the new standard’s requirements by that expiration date.  In order to determine the changes you’ll need to make to your product (if any), a gap analysis is required.  You’ll review the two editions and see if the changes in the revised document impact your product and it’s “technical file.”  Should it not impact your product, nothing further is required.  If it does, retesting will be in order.

It is unfortunate that some of the basic tenets of the New Approach have run into difficulties where medical devices are concerned.  Certainly, it appears that some of the trouble has occurred because of the preference of the European system to adopt standards developed at the International level when possible.  Since Europe makes up 20% of the membership of the International standards organizations, it is a great economic benefit to have standards aligned at both the international and European regional levels.  However, in the case of some of these medical device standards, the degree of risk mitigation is not stringent enough at the international level to meet the European legislative requirements.

Of course, these changes are rippling through the standards community even as we speak.  Will the net result be a change to the legislation or changes to the standardization?  Only time will tell…

If you need help with your documentation for compliance, turn to Document Center Inc.  We’ve helped thousands of companies just like yours.  Reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Or head to our website at www.document-center.com.  We’re your Standards Experts!

New AAMI ST91 – Cleaning endoscopes

AAMI ST91, “Flexible and semi-rigid endoscope processing in health care facilities,” has just been released.  This new standard was developed to help organizations reduce the risk of cross-contamination between patients who undergo endoscopic procedures.  The use of endoscopes is extensive (there are more than 11 million gastrointestinal endoscopies performed each year).  However, more health care acquired infections have been linked to endoscopes than to any other medical device.  So while infection is rare as a percentage of outcomes, the numbers are still significant.  If your facility uses endoscopes, you will want to get a copy of this new publication.

The new standard provides guidelines for the following processes:  pre-cleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing.  The types of endoscopes covered by this standard include flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes like flexible ureteroscopes, and semi-rigid operative endoscopes like choledochoscopes.  Guidelines are intended to be used in health care facilities.  The document provides comprehensive information and direction for personnel who handle the processing of these devices and accessories.

The committee actually started out writing a Technical Report, intending to create a document that would gather together all existing guidance in the area.  However, during development it became clear that more guidance was required than existed at the time.  So the publication has expanded to become an American National Standard.

AAMI ST91 starts with the usual scope and definitions sections.  Clause 3 reviews the design of the endoscope processing area, including work flow considerations, etc.  Clause 4 discusses personnel issues, like training, hygiene, clothing, policies, and immunizations.  Clauses 5 to 9 cover various topics in sterilization and processing itself, including automated endoscope reprocessors, sterile endoscope sheaths, and processing accessories.   Clauses 10 and 11 are focused on storage and transport.  Finally a lengthy Clause 12 discusses the many facets of quality control required in this setting.  A 5-page bibliography completes the document.

You’ll want to get a copy and you can order online at Document Center’s webstore, www.document-center.com.  AAMI standards are available in both paper and pdf format, as well as part of our Standards Online multi-user subscription service.  As an authorized AAMI distributor, Document Center can offer you not only the publication, but affiliated services to assure the proper use of compliance information in your organization.  Make us your Standards Experts!

New ISO/IEC TS 38501 – IT Governance

ISO/IEC TS 38501, “Information technology – Governance of IT – Implementation guide,” has just been released.  This technical specification was developed to compliment ISO/IEC 38500 (recently revised) on IT governance for the organization and ISO/IEC TR 38502, the framework and model report.  It specifically addresses the issue of implementing an IT governance strategy with the goals of avoiding the risks associated with software and maximizing the value of IT investments.

IT (Information Technology) is being used more widely than ever in automating business processes and for communication (and transactions) between staff, customers and suppliers.  Poor implementations, however, can result in damage both in dollar terms and to company reputations.  Since in the end these are really  management issues, oversight is needed. This is best achieved using IT governance.

You’ll use the ISO/IEC 38500, “Information technology – Governance of IT for the organization,” for the requirements for IT governance.  But both the ISO/IEC TS 38501 and the ISO/IEC/TR 38502 provide you with support and guidance to implement those requirements.  How will the ISO/IEC/TS 38501 help you?

Let’s look at the structure of the technical specification.  First there’s the usual scope and reference documents clauses.  Then the publication dives right into the heart of the matter with Clause 3 on your implementation approach.  This is a review of the cyclic process model that is best suited to the task:  Setting up and maintaining an “enabling” environment, providing the governance itself, and continually reviewing for improvements.  The three following Clauses each elaborates on the one of the 3 “legs” of this process.  Clause 5 on Govern IT is particularly lengthy and provides in depth guidance to support your efforts.  Two informative Annexes provide you with additional information.  Annex A covers your assessment scheme for IT and Annex B reviews the ISO/IEC 38500 principles and assessment criteria.  The 2-item bibliography completes the document.

Now you’ll need to get copies.  Order online at the Document Center Inc. webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Document Center is an authorized dealer for ISO and IEC standards, providing copies in paper format, for pdf download and as part of our multi-user Standards Online subscription service.  Make us your Standards Experts!

 

ISO/ASME 14414 released for pumping systems

ISO/ASME 14414, “Pump system energy assessment,” has just been released.  The new 1st Edition is available from Document Center Inc. in both paper and pdf formats, as well as part of our Standards Online multi-user subscription service.  It is notable because it represents a new standard that has been co-authored by both ISO and ASME.  And, as a further note, it was developed using the process defined by ANSI, the American National Standards Institute, and has already been adopted as an ANSI standard!

How was this accomplished?  ISO Technical Committee 115 (specializing in Pumps) collaborated with the ASME Committee EA (for Industrial System Energy Assessment).  The two groups joined to develop this standard specifically for the assessment of pump systems.  You’ll use it to identify and quantify pump system energy use for potential savings and improved reliability opportunities.  You probably know this type of assessment as energy audits, energy surveys, energy assessments or energy studies.

What is the goal for this standard?  It’s been designed for open and closed loop pumping systems typically used at industrial, institutional, commercial, and municipal facilities.  The committee anticipates that it can contribute to decreased energy consumption to reduce an organization’s carbon footprint.  You may prefer to think of it as an aid to reducing costs generated by inefficient pumps.  One specific benefit that you can get by using the standard is in evaluating services offered by various auditing organizations.

What’s in ISO/ASME 14144?  You’ll find the usual scope, referenced documents and definition sections to begin with.  Then comes Clause 4 on the identification of the assessment team, its authority and functions.  Clause 5 covers the assessment itself and how it should be conducted.  Finally Clause 6 wraps things up with information on reporting and documentation.  There is one required Annex, Annex A on the contents of the report itself.

I think you’ll find the balance of the Annexes to be very helpful.  They cover:

  • Recommendations on efficient system operation and energy reduction – examples.
  • Expertise, experience and competencies (of your auditors).
  • Recommended guidelines for analysis software.
  • An example of a prescreening worksheet.
  • Specific energy (what it is and how to calculate it).
  • Pumping system parasitic power (again, what it is and methods to calculate).
  • An example of pumping system efficiency indicator (a first-pass indicating tool).

A 15-item bibliography completes the publication.

Now to get a copy.  Order online at Document Center’s 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’ve been an authorized dealer for ISO standards since the 19990’s.  Make us your Standards Experts!

New ANSI Z88.2 2015 Released

ANSI Z88.2, “Practices for Respiratory Protection,” has just been released.  This new edition has been in the works for some time, as the previous 1992 Edition was withdrawn in 2002.  The committee considers this 2015 Edition to be a complete new standard rather than a 4th Edition, so if you use the document you’ll need the copy of the updated release.  You can get your copy from Document Center Inc. in both paper format and for pdf download.

The standard is essential for understanding the minimal requirements and practices for occupational respirator use.  These devices are used to protect people from the inhalation of harmful air contaminants in the workplace.  And they also are used in oxygen-deficient atmospheres.  You’ll get information and guidance on the right way to select, use and maintain respirators as well as establishing respirator programs.

Please note:  This standard is not appropriate for use with underwater breathing devices, aircraft oxygen systems, supplied air suits, respirators used in military combat or medical inhalators or resuscitators.

ANSI Z88.2 was developed after significant changes to the OSHA respiratory protection standard (29CFR 1910.134).  So this means that there are new government definitions and requirements for APF’s (Assigned Protection Factors) and MUC’s (Maximum Use Concentrations).  And changes were also made to the OSHA rules for Fit Testing Procedures.  So references are made in the 2015 Edition for Z88.2 to the ANSI Z88.10 standard, “Respirator Fit Testing Methods,” from 2010 which addresses some of these issues.

Where will you find other changes to the publication?  There are updated sections on oxygen deficiency, respirator selection, the use of emergency respirators, and on respirator audits.  There is also an Annex A with guidance on a number of topics:

  • A.1 Guidance on Establishing Cartridge and Canister Change Schedules
  • A.2 Respirator Classification by Mode of Operation and Considerations for Selection and Use of Respirators
  • A.3 Oxygen Deficiency
  • A.4 Verbal Communications
  • A.5 Required Fit Factor
  • A.6 Positive-Pressure Designation
  • A.7 Effective Protection Factor (EPF)
  • A.8 Decontaminating, Cleaning and Sanitizing Respirators
  • A.9 Dew Point
  • A.10 Breathing Air Equipment and Systems

You are probably aware that this standard is closely linked to OSHA regulations.  You’ll be glad to know that there are plenty of references in the ANSI Z88.2, 2015 Edition, to these regulations and supporting material to help you meet your legal requirements.

Now to get your copy.  Order online at the Document Center Inc. 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 working with standards since 1982.  Make us your Standards Experts!

New Revision for ISO 8600-2 on Endscopes

ISO 8600-2, “Endoscopes – Medical endoscopes and endotherapy devices – Part 2: Particular requirements for rigid bronchoscopes,” has just been updated.  The new 2nd Edition is available now from Document Center Inc.  It cancels and replaces the 1st Edition from 2002 and is considered a “minor” revision.  However, if you use this standard you will need to get the new Edition, as the 1st Edition is now obsolete.

Rigid bronchoscopy is an invasive surgical procedure usually performed in an operating room.  These types of endoscopes allow for illumination for visualization of the larynx, trachea and bronchi.  It is used for dilation, stent insertion, laser ablation, or the extraction of foreign bodies.  Or it may be used as a sheath for the insertion of another endoscope, aspirator, or other devices, as well as a gas passageway.

Your ISO 8600-2 standard provides you with the usual scope, referenced documents and terms and definition clauses.  Clause 4 covers requirements such as the dimensions and side apertures.  Clause 5 is dedicated to the various tests you’ll use for this type of equipment.  These tests include pressure drop, attachment security for jet-injectors, and so on.  The last three clauses cover marking, the instruction manual, and packaging.  The committee particularly points out the value of the Annex A, providing a rationale for the document.  This allows those who did not work on the development of the standard to understand the reason each of the requirements have been included.  A bibliography completes the publication.

The ISO 8600 series consists of 7 Parts, all specifically for medical endoscopes and endoscopic accessories.  If you need a copy of this new release, any of the other parts of the series, or any ISO standard at all, head to the Document Center webstore at www.document-center.com and order your copy online.  You’ll be able to purchase these standards in either paper format or for pdf download.  And should you want to have multi-user access, ask our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New EN 455-3 2015 Edition – Medical Gloves

EN 455-3, “Medical gloves for single use. Requirements and testing for biological evaluation,” has just been updated.  The new 2015 Edition is available from Document Center Inc. in a number of national editions.  It replaces the previous 2009 Edition, which is now obsolete.  EN 455-3 gives methods for protein testing, powder levels, and endotoxin levels.   FYI: Extractable latex proteins have an important role in latex allergy.

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labeling and the disclosure of information relevant to the test methods used.  It differs from ASTM D5712, “Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method,” in that it addresses medical gloves only.  It is one of the harmonized standards for the Medical Device Directive, 93/42/EEC.

What kinds of changes will you see in the new edition?  Here’s an outline provided in the draft edition of the update:

  • references to the relevant parts of EN ISO 10993 for Biological evaluation of medical devices are added.
  • Other “normative” references were revised, including the substitution of EN 15223-1 for EN 980, which is now obsolete.
  • Clauses 4.2, 4.4 and 4.6 were updated.
  • The term “As low as reasonably practicable” (ALARP) was removed
  • The symbol for products containing natural latex was removed.
  • Annex B has been updated.
  • There’s a new Annex ZA corresponding the standard to the Personal Protective Equipment Directive (89/686/EEC).

Will you need to purchase a copy of the new standard?  If you sell single use medical gloves in the EU, you certainly will.  There are a number of editions to choose from, and not all are updated yet.  Order on the Document Center Inc. webstore at www.document-center.com.  Your choices will be BS-EN-455-3, SS-EN-455-3, and DIN-EN-455-3.  Since these are the national publications of the source EN document, there is a slight administrative lag as the new editions work themselves through the publication process in each jurisdiction.  Questions?  Just check in with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!