New ISO 80601-2-70 – Sleep Apnoea Equipment Safety

January 26th, 2015

There’s a new standard from ISO on sleep apnoea equipment: ISO 80601-2-70, “Medical Electrical Equipment – Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment.”  This new issue is available now from Document Center Inc.  You can purchase your authorized copy in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  This new document replaces the ISO 17510-1, which is now obsolete.

The ISO 80601-2-70 not only is an update of the ISO 17510-1 but also includes an alignment of the information with IEC 60601-1, Edition 3.0, and IEC 60601-1-11.  It contains a multitude of changes.  Most notably, it identifies essential performance for sleep apnoea breathing equipment and accessories.  It also adds new symbols and tests to be used for therapy performance.

For those of you using the ISO 17510-1, you’ll note that the committee suggests a 3 year transition period for new design equipment and of 5 years for equipment already in production.  However, you’ll want to follow the exact implementation dates as issued by any legal jurisdiction where you sell product.

Another thing to note about this standard is that is covers equipment intended to be used for what’s called obstructive sleep apnoea (OSA).  It is not meant to cover therapy equipment that’s used for central sleep apnoea, where the brain actually fails to initiate a breath.

Also, equipment covered by this standard is for patient use.  And ISO 17510-2 remains in force for requirements for masks and accessories used to connect the patient to the equipment itself.  That is, ISO 80601-2-70 covers the equipment and breathing tube.  The ISO 17510-2 covers the mask and headgear.  There is a patient/connection port that connects the two elements.

This standard will not only provide you with specific information for your equipment, like tests, markings, and so on.  It also gives you a number of tables with information on how ISO 80601-2-70 relates to the other equipment safety standards that you’ll be required to meet.

Also, a final point.  This is an unusual series in that some of the documents in the 80601-2 group are published by IEC and some are published by ISO.  Should you go to search for a document in this series, you’ll want to be aware that you may need to search by the acronyms of both source organizations.

Meantime, if your company makes sleep apnoea equipment, you’re going to need a copy of this new standard.  You can order it online at Document Center’s webstore, 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 working with customers like you since 1982.  Our expertise is unparalleled.  Make us your Standards Experts!

Standards and Compliance

January 23rd, 2015

Compliance is an increasing issue for many of our Document Center customers.  And for us Standards and Compliance are the focus of many of our products and services.  Why?  We’re here to promote and assist our customers’ quality programs, contract and compliance requirements, and the use of best practices through the use of standards.

Of course, for many people the first question is “How do standards fit into a compliance program?”  Many times standards are used in product definition and contract fulfillment.  Or they may be an essential part of meeting regulatory and legal requirements.  And as part of many certification programs, there needs to be a way to manage these publications.

Over the coming weeks, I’ll be reviewing how to set up a program to identify and control the standards you use in your business.  And I’ll be providing you with information on the services Document Center provides to make this program as easy as possible for your organization.

Here’s the steps that need to be taken in order to set up a document control system for the standards you use (and should use) in your business:

  1. Identify those standards that need to be controlled (managed) and who needs to use those documents as part of their job function.
  2. Assess the status of the documents you currently have.
  3. Procure the correct editions for your controlled set.
  4. Make the current editions of your controlled set available to the appropriate personnel.
  5. Monitor and update your standards as necessary.
  6. Notify users when “their” documents change.
  7. Provide a methodology for gap analysis when new revisions are issued.
  8. Have a system for spotting newly released standards not on your controlled list that may affect your business.

Document Center has a wide range of services that make achieving compliant document control possible.  We have auditing and notification services, multi-user site licensing for standards,  online access to standards, and current-awareness programs available.  You’ll use our suite of products to set up a system that is appropriate to your business.

Document Center’s customers rely on us as a critical component of their solution for standards and compliance.  With over 30 years experience in this field, we have the expertise to solve the problems that come with any standards collection.  Check us out at our website, www.document-center.com.  Or contact our staff for more information.  You can reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New IEC 60601-1-11 Edition 2.0 – Homecare Medical Devices

January 22nd, 2015

IEC 60601-1-11, “Medical Electrical Equipment – Part 1-11: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment,” has just been revised.  The new Edition 2.0 is available now from Document Center Inc., an authorized distributor of the IEC standards.  You can purchase your copy in paper format, for pdf download, or as part of our multi-user Standards Online subscription service.

The IEC 60601-1-11 addresses the challenge of safety for devices that are used in an “uncontrolled” (non-clinical) environments.  The major problem is the potential for untrained operators to be controlling medical electrical equipment.  What instructions are most appropriate for this user base?  And what warning markings should be put on the equipment itself?

The standard has been in use since 2010 and this represents the first significant updating of the document.  There are a broad range of revisions and you may want to purchase the redline edition in order to spot all the changes in this new release.  Just ask our staff about the cost when you place your order.

Here’s information on what the primary changes are:

  • The test method for relative humidity has been corrected.
  • A number of subclauses have been re-written to insure that they do not alter IEC 60601-1 or the other relevant collateral standards.
  • The document has been harmonized with various amendments to IEC 60601-1 and it’s other collateral standards.

You’ll find changes throughout the document itself.  The update is technical and extensive.  You’ll want to get your copy of the new document right away if you are using the previous edition.  This is especially true since compliance with this document is a requirement for a number of regulatory jurisdictions, including the U.S., Europe and Canada.  While the adoption of the new edition in these regions may take some time due to administrative procedures, you’ll want to be prepared for the eventual need to meet these new requirements.

So the next question is: “How do I get my copy of the new IEC 60601-1-11?”  Head to Document Center’s webstore at www.document-center.com and order online.  Or contact our staff via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been an authorized dealer of the IEC standards since the 1990’s.  Make us your Standards Experts!

New ISO/TR 28380-3, Deploying IHE Health Informatics Standards

January 21st, 2015

ISO/TR 28380-3, “Health informatics – IHE global standards adoption – Part 3: Deployment,” has just been released.  You can get a copy in paper format, for pdf download, or as part of a multi-user online subscription service from Document Center Inc.  The new publication completes the ISO/TR 28380 series on adopting the IHE (Integrating the Healthcare Enterprise) standards.

A common question standards users have is “How do I choose the standards to implement?”  For Health Informatics, there’s a global process underway to help answer that dilemma.

IHE is an initiative of healthcare professionals, providing a methodology for the adoption and implementation of standards in a group of “domains” or areas of interest.  Each domain generates a technical framework document.  This is a roadmap to what standards are required for IT integration at the international level, what standards currently exist for implementation, and what standards are still needed.  Various standards bodies oversee each domain.  For example, the ADA (American Dental Association) oversees the Dental Domain.

Exchanging health information electronically is a new and challenging discipline.  The ISO 28380 series provides a way for folks to implement the standards championed by IHE and test the results for compliance and interoperability.  It underscores the proposition that the value of standards is in actually using them.  And it allows for the spread of “lessons learned” since it is based on actual documented use cases.

Who should be using the ISO/TR 28380-3 (and the rest of the series)?  It’s intended for a broad range of users.  These include IT departments at healthcare institutions, those in the healthcare information technology industry, standards developers, and anyone interested in the integration of healthcare information systems and workflow (including regulators and the like).

What exactly does ISO/TR 28380-3 bring to the table?  This part 3 shows you how to analyze your interoperability requirements in the support of your use case.  You’ll use this information to produce the selection and combination of the profiles detailed in ISO/TR 28380-2.  You’ll get a number of examples to help you do this.  And it will show you the benefits you can expect by using this methodology for your standards adoption process.

What’s exactly in the ISO/TR 28380-3?  You’ll find the usual scope, referenced documents, and definitions clauses to start.  Then there’s an abbreviations section, focused on the various standards organizations and terminology acronyms common in this discipline.  There are an additional 4 clauses.  They cover the general approach used, the project interoperability specification, deployment benefits, and the approach to testing.  An eight item Bibliography completes the document.  Special value may be found in topics covered like establishing a jurisdiction interoperability framework and test management processes and certification.

What are the other parts of the ISO/TR series?  They are:

  • ISO/TR 28380-1, Health informatics – IHE global standards adoption – Part 1: Process
  • ISO/TR 28380-2, Health informatics – IHE global standards adoption – Part 2: Integration and content profiles

How can I get the ISO/TR 28380-3?  Head to Document Center’s webstore at www.document-center.com and order your copy now.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing authorized copies of ISO standards to our customers since the 1990’s.  Make us your Standards Experts!

New ASTM D4332 2014 Edition – Preparing Packages for Testing

January 20th, 2015

ASTM D4332, “Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing,” has just been updated.  The new 2014 Edition (released in 2015) is now available from Document Center Inc.  You can get your copy in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  The document provides you with a methology for “conditioning” packages and packing systems in preparation for testing.

If you regularly read my blog, you know that the ASTM D4169 standard for testing shipping containers was recently revised.  The ASTM D4332 is one of the referenced documents in that standard, providing a way to simulate the effect of various atmospheres on the materials of the packaging system that will be tested.  It is also referenced in a number of other package testing standards like the ISTA 2A.

How will you use the document?  Before you test a package or shipping container for applicability, you’ll need to simulate the conditions that it will be expected to endure.  One of the most obvious conditions is atmospheric.  For example, if moisture is a factor, you’ll need to test the package after it is damp.  The D4169 provides you with the protocol to use to “condition” the test sample — that is, bring it to the same atmospheric conditions you’ll expect the package to be used in.

What’s new in this 2014 Edition?  References to an ISO standard in the document have been removed.  And updates have been made to both the scope paragraph and clause 5 on atmospheric conditions.  Additionally, Clause 7 on procedure has also been modified.

If you’d like to have the exact changes in an easy-to-use format for any updated ASTM standard, just ask for the Redline Edition when you place your order.  You’ll get both a clean copy of the new release and a “marked-up” copy of the previous editions which allows you to easily spot all revisions.

Order at the Document Center website at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you in your purchases, in setting up your system to monitor and maintain your collection, or provide access to standards for your staff in a compliant environment.  Make us your Standards Experts!

New NEMA 250, Electrical Enclosures

January 19th, 2015

NEMA 250, “Enclosures for Electrical Equipment (1000 Volts Maximum),” has just been updated and the new 2015 Edition is available from Document Center Inc. now.  This new update replaces the previous 2008 edition (now obsolete).  It covers the topic of cabinets for electrical equipment, ones that are commonly used for providing protection from the elements and to equipment users, and from access by unauthorized personnel.

The NEMA 250 is widely used not only by manufacturers, but by enclosure purchasers to determine what enclosure suits their purposes best.  It also provides information on features expected from an electrical enclosures.  And it defines the tests used to confirm that a given enclosure meets various environmental requirements.

The standard covers enclosures used for both hazardous (called classified) and non-hazardous (termed unclassified) locations.  Unclassified locations are covered in the main body of the standard and classified are in Annex A.

NEMA 250 starts with the usual scope, references, and definition clauses.  Then it reviews the types, features and applications for these electronic enclosures.  You’ll also find specific requirements for both construction and marking.  And there are a number of tests for these products:  rain, dust, salt spray, corrosion, and so on.

Who should be using this document?  It’s primarily addressed to enclosure manufacturers since it provides performance requirements for various classes of electrical enclosures.  In additional, this provides electrical enclosure purchasers with the tools to assess and compare the many types of enclosures available on the market today.

Need a copy?  Head to the Document Center webstore at www.document-center.com and order it now!  Or 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 NEMA standards since the 1980’s.  Make us your standards experts.

What makes a Harmonized Standard?

January 16th, 2015

I recently had a customer ask me, “What makes a Harmonized Standard?”  The customer was referring to the EN Harmonized Standards and wondered if all EN publications are harmonized.  As is often the case, this is actually a technical question and it depends very much on the process of standardization followed in the European Union.

Of course, there is a simple answer.  A European Harmonized Standard is mandated by the European Commission.  Once developed it must be adopted legislatively according to specific rules.  It then allows for the presumption of conformity, that is, by using a specific harmonized standard your product is presumed to comply with the requirements of a specific directive.

However, knowing how EN standards are developed is helpful here.  And the primary issue is actually the difference between standards for commerce and standards for legislated health and safety concerns.

Since EN Standards started out as a tool for creating a common market in Europe, there are many different paths a document can take in order to become a European Norm (standard).  The first big push for standardization at the European regional level was started in order to remove national differences in a wide variety of publications.  This involved national standards bodies putting forward various national standards for regional acceptance.  And the politics of adoption were challenging.

Now, with the first wave of standardization behind them, the European standards bodies develop standards for industry, consumer, and other market-driven needs.  But there is another function of standardization:  Supporting legal and regulatory requirements.

This is where the harmonized (or harmonised) system has come into being.  As various directives have been issued in the European sector, companies want to know how to meet the requirements of these legal mandates.  Standards are the perfect tool, but there needs to be some way to verify that conforming to a particular standard can meet the obligations of a particular directive.

The EU has set up a system to provide a way for manufacturers and suppliers to insure that they are in compliance — the concept of presumption of conformity.  This system is not used for all EN standards.  Indeed, harmonized standards make up a small proportion of the whole body of EN publications.

Remember, a Harmonized Standard has to be linked to a directive.  Indeed the request for the standard has to come from the administrative side of government, specifically to provide a way to meet the requirements of a legislative mandate.  So when a Harmonized Standard is issued there must be a directive that it applies to.  And the standard has got to go through an administrative vetting process to be accepted as meeting the directive’s criteria.

This is why Harmonized Lists don’t get updated right away when standards on the list get updated.  The new revisions have to be reviewed by administrators on the government side to confirm continued compliance.  And then they need to have the completion of the process acknowledged by publication of acceptance in the OJEU, Official Journal of the European Union.

Whew!  Who knew that the use of standardization for government goals could be so complicated?  Guess what!  It’s actually a common situation.  While legislation usually doesn’t change very often, standards are a different story.  Administrators in all jurisdictions are constantly challenged with reviewing changing technical requirements and making sure that their constituents continue to be protected.  And we wouldn’t really want it any other way!

If you have standards questions, or need to purchase them, get in touch with us.  You can order standards at the Document Center webstore, 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’re your Standards Experts!

New ISO 17258 – Benchmarking Six Sigma

January 15th, 2015

There’s a new ISO 17258, “Statistical methods – Six Sigma – Basic criteria underlying benchmarking for Six Sigma in organisations.”  You’ll be able to get a copy in paper format, for pdf download or as part of a multi-user online subscription service from Document Center Inc. now.  The standard gives users a methodology to use in Six Sigma programs to compare your organization with “state-of-the-art.”

Having watched quality initiatives since the 1980’s, I have to admit that I consider Six Sigma to be one of the most transformative statistical tools out there.  Originally developed by Motorola, it was standardized with the release of ISO 13053-1 and ISO 13053-2 in 2011.  It relies strongly on verifiable data, clear business and quality goals, and strong leadership and support.

The ISO 17258 is intended to help you understand what benchmarking is, and what data needs to be collected in order to achieve valid benchmarking results.  This may be for internal, external, or supply chain benchmarking.  And it can be used in Six Sigma and Lean Six Sigma programs alike.

Why would you find ISO 17258 to be helpful?  Data can be collected on many aspects of a business.  Knowing what data will assist you in reaching your goals is essential to any quality project.  And understanding how to confirm the validity of your measurements and how to do your comparisons can make the difference when reaping the returns of such a program.

What’s covered by the standard?  The body of the standard is divided into 8 clauses:

  1. Scope
  2. Reference documents
  3. Terms and definitions
  4. Symbols and abbreviations
  5. General considerations for benchmarking
  6. Benchmark (criteria and criteria measurements)
  7. Benchmarking (steps in the process)
  8. Interfacing with other types of benchmarking

Another great feature are the Annexes.  The first, Annex A, covers the three dimensions of benchmarking (productivity, quality and cost).  Annex B covers a generic table of criteria.  Annex C is a table of those criteria matched to results.  The balance of the 11 Annexes provide you with information on criteria for specific industries like the food industry, automotive, retail, and so on.  A bibliography with 5 citations completes the publication.

If you’re involved in a Six Sigma effort, you’ll want to get a copy of the new ISO 17258.  Head to the Document Center webstore at www.document-center.com and order your authorized copy.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

New IEC/TR 80001-2-5 – Alarm Systems for Networked Medical Devices

January 14th, 2015

There’s a new IEC/TR 80001-2-5, “Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems.” This new publication extends the series on safeguarding computer networks that include medical devices.  It can be purchased in paper format, for pdf download or as part of a multi-user online subscription service from Document Center Inc.

The IEC 80001-2 Series addresses the issue of risk management for networked medical devices in general and this new part specifically deals with the issue of alarms.  To set up your networked alarm system, you’ll need to know how to identify hazards and the causes for them.  Then you’ll need to identify, implement, and verify your risk controls.

How will you know that this new Technical Report applies to your situation?  The essential requirement for using the standard is that your alarm system involves at least one medical device and a communication path that uses an IT (Information Technology) network.

What’s covered by the IEC/TR 80001-2-5?  Of course, there’s the usual scope, referenced documents and definitions sections.  In this case, the clause for terms and definitions is especially lengthy, since having a common meaning to the various terms will assist you in understanding the balance of the document.

Next Clause 4 reviews the functions that this type of alarm system provides.  Clause 5 provides the basis of determining of the type of system you’ll be using.  And Clause 6 covers the issues that your risk management program for your alarm system needs to address.

There’s an additional four Annexes provided in this document.  The first, Annex A, shows you the relationship of this technical report to IEC 60601-1-8.  Annex B discusses the various types of sources that might generate the alarm state.  Annex C reviews what types of systems are appropriate for various conditions.  And Annex D covers the issue of scalability.  Lastly, an 18-item bibliography finishes off the publication along with a 2-page index of terms used.

FYI:  There are a total of 6 Parts to this series currently available.  Additionally, Part 7 and Part 8 are in preparation at this time.

Now you’ll need to get a copy.  Go to Document Center’s webstore at www.document-center.com and order your authorized copy now.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll be able to help you with this and any other standards-related requirements you may have.  Make us your Standards Experts!

New MIL-STD-1791 B USAF Cargo design

January 13th, 2015

MIL-STD-1791, “Designing for Internal Aerial Delivery in Fixed Wing Aircraft,” has just been revised.  The new Revision B is available from Document Center Inc. in paper format, for pdf download, or as part of our multi-user online subscription service.  This document has gone through a series of revisions and redesignations.  We’ll discuss it’s history and why it is called out in U.S. government contracts.

The MIL-STD-1791 was developed to assist vendors and purchasing agents so that cargo design could accommodate the needs of the USAF in assuring safety during transport in fixed wing aircraft.  It is a compendium of design requirements and operating limits from the various aircraft loading manuals and other technical publications.  It also has other useful air transport information.

It was first released in 1985. However in 1997, it was cancelled and republished as a MIL Handbook.  This meant that the various requirements were not binding, but only to be used as guidelines.  Oddly as it seems, this renumbering left the MIL-HDBK-1791 with a date of 12/14/1997 and two change notices with earlier dates, having been ported over from the MIL-STD without any further changes.

In November 2012, the document again went through a renumbering phase, this time taking it back to the status of a MIL-STD.  This new Revision A was issued as a classified document, which meant that it was not available for public distribution.  Finally in June, 2014, an administrative notice reverted the document to Distribution Statement A status, no restrictions on distribution.

The recent release of the Revision B for MIL-STD-1791 is a complete technical update.  You will not find notations in the margins to guide you to areas where revisions have taken place.  As a standard, the document is now available to be called out in contracts and must be adhered to as part of the agreement.  It provides the user with the general design and performance requirements of USAF developed or off-the-shelf cargo used for internal air transport.  And it also covers the procedure for certifying outsized or unusual cargo as well.

Should you need a copy of this 373-page standard, just go to the Document Center webstore at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We got our start distributing Mil-Specs and Standards so we’re very familiar with these documents and their usage.  Make us your Standards Experts!