New IEC/TR 62726 – Greenhouse Gas reduction for electronics

August 22nd, 2014

The challenge of reducing greenhouse gas is turning into actionable tasks for many industries, including the electrical and electronics sector.  Now IEC has released a technical report that identifies a methodology for quantifying greenhouse gas (GHG) emissions for this industry.  The new document is the IEC/TR 62726, “Guidance on quantifying greenhouse gas emission reductions from the baseline for electrical and electronic products and systems.”   It’s been written to help you set a baseline for evaluating your contribution to the reduction of these gases.

Benefits to you?  You’ll have an easier time incorporating GHG-reduction targets into your R&D efforts.  You’ll have a level playing field when discussing the impact of your efforts.  And it will help you reduct the costs of setting up your program.

What will you find in the IEC/TR 62726?  The document reviews the relevant standards and regional initiatives so you’ll better understand the existing methologies for GHG reduction studies.  And by relying on existing International Standards, the guidance it provides is comprehensive.

If you’re in this space and are wondering how to get your GHG reduction project off the ground, you’ll find this report to be invaluable.  You’ll soon learn what documents are applicable to your efforts, what clauses in those documents affect your process, and how you can best implement them.

Of course, you’ll need a copy and you’ll want to use an authorized dealer like Document Center Inc.  Order the report on our website, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be able to purchase your copy in paper format, as a pdf download or as part of our multi-user subscription service Standards Online.

Automatic update notification comes free with your purchase, so you don’t need to worry about future changes.  And you’ll have the resources of Document Center available to you for additional services like auditing your standards collection, providing you with current awareness services, standing order service and more!  Good reason to make Document Center your Standards Experts!

New ISO 8124-6 – Toy Safety – Phthalate esters

August 21st, 2014

Toy safety is a top concern and over time the standards in this area have gained wide acceptance.  Concurrently, regulatory requirements have multiplied, providing manufacturers with the challenging task of meeting diverse requirements for products with a short shelf life.  Now to assist in meeting conformity assessment requirements, ISO 8124-6, “Safety of toys – Part 6: Certain phthalate esters in toys and childrens products,” has been released.  Based on the GB/T 22048 (available in Chinese language only), the standard does not set limits for the inclusion of phthalate esters.  Rather it provides you with a method for determining how much of the various kinds of phthalate esters exist in toys and children’s products.

Phthalate esters themselves are used in plastics to provide greater flexibility and improved ability to hold color and/or fragrance.  They actually have a weak bond, so they are one of the major plastics pollutants in the environment.  Although they have not been shown to be toxic, there is concern that over time exposure can have negative effects (both developmental and reproductive).  Because of this, various jurisdictions have enacted regulatory limitations on the inclusion of these substances in children’s products.

As a toy manufacturer or distributor, you’ll rely on the use of the ISO 8124-6 to test your product(s).  It’s basically a process when a small piece of the item is processed for determination of phthalate esters both qualitatively and quantitatively by gas chromatograph-mass spectrometry.   The standard covers the reagents, apparatus, selection of the test portion and the procedure, calculation, quality control, precision and the test report itself.

There are an additional six Annexes.  Annex A contains the only required material — A table of the various kinds of phthalate esters themselves.  While the remaining five Annexes are informative, they are actually quite technical and provide essential information for the successful use of the standard.  A 12-item bibliography finishes out the document.

The new ISO 8124-6 is the 5th part of the series to be published.  The balance of the series (both available and in process) are:

  • ISO 8124-1, Safety of toys – Part 1: Safety aspects related to mechanical and physical properties
  • ISO 8124-2, Safety of toys — Part 2: Flammability
  • ISO 8124-3, Safety of toys Part 3: Migration of certain elements
  • ISO 8124-4, Safety of toys — Part 4: Swings, slides and similar activity toys for indoor and outdoor family domestic use
  • Proposed ISO 8124-5, Safety of toys — Part 5: Determination of total concentration of certain elements in toys
  • Proposed ISO 8124-7, Safety of toys — Part 7: Requirements and test methods for finger paints
  • ISO/TR 8124-8 (Just released!), Safety of toys — Part 8: Age determination guidelines

You’ll need a copy of the new ISO toy safety standard, and you can purchase an authorized copy from Document Center Inc.  You’ll have the option of getting it in paper format, as a pdf download, or for multi-use access in our Standards Online subscription service.  Order through our website, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

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New ASME Y14.35 on Document Revisions

August 20th, 2014

The ASME Y14 series of drafting standards is an essential part of the engineering toolkit.  A number of documents in the set have been updated during the last year or so.  Now the ASME Y14.35, “Revision of Engineering Drawings and Associated Documents,” has been revised.  The new 2014 Edition replaces the previous 1997 Edition, which was numbered ASME Y14.35M (now obsolete).  You can order your copies of the new publication from Document Center Inc. now.

This part of the series addresses the issue of releasing revisions for drawings and documents.  It’s not uncommon for companies to have questions about this, since internal documentation is part of many organizations’ engineering resources.  The Y14.35 identifies what revisions are and covers how to identify and record them.

Updates to the previous edition are found in the following areas of the standard:

  • Paragraph 1.1, the Scope section
  • Paragraphs 3.4, 3.8.1 and 3.8.2, and 3.27 in the Definitions Section
  •  Paragraph 4.7 in the Drawing Practices Section
  • Paragraph 5.2 in the Edition Identification Section

Since the new edition is a technical update, you’ll want to get a copy if you use this document.  You can order it on the Document Center website 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).  The document is expected to ship in early- to mid-September.

Once you have your copy, you’ll get the reaffirmation stickers free if the document is reapproved during the period that it’s in force.  And when it’s updated, you’ll get an email notification.  Since 1982, Document Center Inc. has been providing customers with access to standards and supporting services to insure the correct use of this compliance information.  Make us your Standards Experts too!

New ISO 14708-1 2nd Edition for Surgical Implants

August 19th, 2014

For implantable medical device manufacturers, the ISO 14708 series is essential.  Now the ISO 14708-1, “Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer,” has been updated.  The new 2nd Edition is a technical revision of the original release in 2000 (which is now cancelled).  It’s the first in the series and covers the general requirements for active implantable medical devices in terms of basic safety.

The standard has 24 specific requirement clauses that generally cover all implantable medical devices.  First, the general requirements are spelled out.  These include such things as software, related non-implantable parts, data security, risk management and mis-connection.  Then, more specific areas are addressed.  Packaging, information, marking, etc., are also covered since the mis-use of devices can be as harmful as device failures.

Harmful effects for both the patient and for the device are considered in this document.  What kinds of factors could be harmful?  Well, patients could be harmed by radiation, unintended biological effects, electricity and a number of other concerns.  The device itself can be affected by heat, atmospheric pressure changes, electrical fields and the use of defibrillators, electrostatic discharge and so on.

Your standard addresses all of these factors in order to confirm that you have considered all risk factors your device may face.  Additionally, two Annexes cover general guidance and the relationship between the ISO 14708-1 and ISO/TR 14283, “Implants for surgery – Fundamental principles.”  A 28-item bibliography finishes the publication.

You’ll also want to review this new edition if you use any of the other parts of the ISO 14708 series, since they provide additional information for specific device types.  Here’s the list of the additional topics they cover:

  • ISO 14708-2, Part 2: Cardiac pacemakers
  • ISO 14708-3, Part 3: Implantable neurostimulators
  • ISO 14708-4, Part 4: Implantable infusion pumps
  • ISO 14708-5, Part 5: Circulatory support devices
  • ISO 14708-6, Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
  • ISO 14708-7, Part 7: Particular requirements for cochlear implant systems

When it’s time to order your new edition, you’ll want to get it from an authorized ISO dealer like Document Center Inc.  You can order at our web store at www.document-center.com, with options for either paper or pdf delivery.  If you’d rather, you can choose multi-user access by contacting our staff and setting up a Standards Online subscription for your company.  We’ve been providing standards and supporting services to our customers since 1982.  Make us your Standards Experts!

New ISO/TR 19244 – Transition Periods

August 18th, 2014

It’s not uncommon for Document Center customers to ask about transition periods — the time that is allowed for compliance when a new edition is released.  Happily, some standards do provide you with that information within the document itself.  But when there’s no guidance, what’s the proper protocol?  Now ISO committee TC84 has issued a new technical report addressing that very issue.  It’s ISO/TR 19244, “Guidance on transition periods for standards developed by ISO/TC 84 – Devices for administration of medicinal products and catheters.”  And it’s available now from Document Center Inc. in paper format, for pdf download and as part of our multi-user Standards Online service.

The new document has been written specifically for the TC 84 standards.  They cover such things as needle-based injection systems, sharps, aerosol drug delivery systems, needles, syringes, and catheters and ports.

The technical report covers two main concepts:

  • Grandfathering – accepting a device meeting the previous edition due to good safety and performance records.
  • Transition period – the time that you have to meet the criteria of the new edition for either existing products or products that are about to be released to the marketplace.

Why have a transition period?  Of course, with medical devices in particular, the resources necessary to provide new testing and documentation for modifications can be substantial.  And in fact, changes may need to be made not only to products and product lines, but also to the criteria for regulatory acceptance.

Of course, no standard can override the particular regulatory requirements of a particular jurisdiction.  So you’ll use this document plus the legal protocol for each of the markets where you sell your product(s).  However, having general guidance from the Committee is good news for manufacturers in this space.

You’ll need a copy of ISO/TR 19244 in order to understand the committee’s view on the topic.  You can purchase your authorized copy from Document Center Inc. on our website, www.document-center.com.  Or consider getting in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

We’ve been providing standards to our customers from our Silicon Valley location since 1982.  Make us your Standards Experts!

New EN 16571 – RFID Privacy Assessment

August 15th, 2014

Back in 2009, the European Commission mandated the preparation of privacy impact assessments (PIA’s) for devices using RFID (Radio-frequency identification).  And as I learned from the news coverage of the latest hacker conventions, it’s becoming clear that as RFID applications expand into personal devices, privacy concerns are going to only increase.  So we’re pleased to let you know that standardization is moving into this area to provide guidance on the subject.  I’m referring to the new EN 16571, “Information technology – RFID privacy impact assessment process.”

Of course, this standard has been developed in support of trade and the IT applications that rely on RFID in support of transportation activities. It was developed as part of the EU RFID Mandate M/436.  The new document is intended to enable a common European method for undertaking an RFID PIA.

EN 16571 shows you the procedures for developing PIA templates, including tools compatible with the RFID PIA methodology.  And it identifies the conditions that require an existing PIA to be revised, amended, or replaced.

What will be the benefits of using the EN 16571?  First, you’ll have a structure to set up and maintain a process for insuring you meet privacy and data protection laws and regulations in Europe.  You’ll have a process to minimize the risks associated with breaches of your data infrastructure.  And you’ll have a methodology for implementing a privacy risk management process during the design phase, rather than as an after-thought.

What is the PIA process?  It’s a systematic way to approach the risks involved with the use of RFID devices.  It includes discovery of risks, assessment of the possibility of negative outcomes, and the documentation of the steps taken to minimize those risks.

If you use RFID in your products, you owe it to your organization to review this standard.  Document Center Inc. can help you get a copy.  It can be purchased in any number of national adoptions, but not as a stand-alone document.  We suggest that you review the following editions:

  • SIS EN 16571, Information technology – RFID privacy impact assessment process – Currently available, paper, pdf or subscription format, English language
  • BS EN 16571, Information technology. RFID privacy impact assessment process, Currently available, paper format only
  • DIN EN 16571, RFID privacy impact assessment process, Not yet available (currently in draft format, German language, paper and pdf format)

With our new contract with SIS, the first edition above (the SIS EN 16571) is your best bet, since it’s available in the most formats and at the lowest price (and it is in English!).

You can place your order on the Document Center website 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).  Your purchases always include our notification service.  We’ve been providing customers like you with standards since 1982.  Make us your Standards Experts!

JEP 172 – Why stop using the Machine Model test?

August 14th, 2014

Testing electronic components is a vital part of confirming quality in many products.  One area of concern is component ESD (electrostatic discharge) qualification.  For many years the machine model (MM) test has been widely used.  Now many in the industry feel that it is no longer necessary.  To promote that viewpoint, JEDEC has released the new JEP 172, “Discontinuing Use of the Machine Model for Device ESD Qualification.”

Why release a document like JEP 172?  Change in the protocols of component testing comes slowly, as the need for robustness of this equipment is essential in many applications.  So JEDEC wanted to make the technical case that MM testing no longer serves a valid purpose.

What is the rationale?  MM testing, in JEDEC’s view, is redundant, has more variability, and performs less well in general than other widely used tests.  These include the Human Body Model (HBM), Charged Device Model (CDM), and Electrostatic Overstress (EOS).

The document provides you with background on why the MM testing has come under review, then compares it to the various other options.   It discusses various situations that are tested and why the MM under-performs it’s counterparts.  Then it covers the recommendations of other standards bodies with regards to the usage of MM.  Finally, it wraps up the discussion with a section on it’s conclusions.

If you are involved in IC manufacturing, handling and assembling, you’ll want to review this new publication.  You can get your copy from Document Center’s web store 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).  You’ll be purchasing your JEDEC standards from an authorized dealer, and getting automatic update notifications at no additional charge.

You’ll be able to buy the JEDEC documents in paper format, for pdf download and as part of our new Standards Online annual subscription service.  This means that you have a wide variety of options for compliant single user and multi-user access.  We’ve been providing standards to the electronics industry since 1982 from our Silicon Valley location.  Make us your Standards Experts!

FDA Guidance for Home Use Devices

August 13th, 2014

Medical devices can be used in a variety of settings and now there’s FDA guidance for home use devices.  Titled “Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff,” the new release replaces the draft document issued in 2012.  It is intended to help manufacturers address the unique risks associated with user interactions by non-professionals in homes.

The guidance was deemed necessary due to the rise in folks using medical devices outside of professional health care facilities.  The growth of the home medical care industry, with more patients with chronic illnesses living in home settings, means that home use devices are increasingly in demand.

So this guidance was developed specifically to review the risks associated with devices in the home setting, with considerations specifically developed to minimize those risks.  The FDA is letting you know that you’ll be expected to demonstrate the safety of your home use device as part of your submission data.  And what better time for you to address these issues than in the design phase?

What kind of issues will the FDA be looking at?  Here’s a general review:

  • Environmental considerations (examples are location, contaminants, water supply, air flow, travel, and so on)
  • User considerations (physical, perceptual, cognitive, emotional)
  • Design considerations (lock-out mechanisms, maintenance, calibration, mechanical, electrical)
  • Human factors (user training, certification)
  • Labeling (emergency handling, disposal, hygiene)
  • Post market considerations (customer service, device reporting)

Appendix 1 covers a list of references, including various standards that are mentioned in the guidance document.  Appendix 2 covers additional resources.  Many of these references include websites for the document or organization listed.

Of course, you’ll need a copy of the guidance document itself.  There’s a number of resources, but you may want to rely on Document Center for your purchase.  Why?  Because Document Center tracks the publications we sell and provides you with a no-charge notification when any of your documents are updated.  If you’d been using the 2012 draft of this item, you’d have gotten your notification within a week of the release of the new update.

You can order on our website, 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).  You’ll have a variety of options for your purchase — paper format, pdf download or as part of our Standards Online 24/7 online access subscription service.  Reason enough to make Document Center your Standards Experts!

New ISO 5841-2 3rd Edition – Cardiac Pacemakers

August 12th, 2014

Cardiac pacemakers are used for a number of purposes and in a wide variety of clinical settings, over a number of jurisdictions with varying privacy requirements.  Yet the monitoring of the service life of these devices is essential — to project replacement dates and identify performance issues.  The ISO 5841-2, “Implants for surgery – Cardiac pacemakers – Part 2: Reporting of clinical performance of populations of pulse generators or leads,” was developed to help manufacturers collect and use performance information for device monitoring and patient management protocols.  And a new 3rd Edition has just been released.

First of all, the standard addresses the requirements for reporting of this type of information.  Called post-market surveillance, data on performance is routinely collected by manufacturers.  So the ISO 5841-2 describes reports to be generated from the collected information.  You’ll learn how frequently you should update your reports, where and how you should publish them and what information should be included.  This information for reporting is quite detailed, with tables on categories of confirmed malfunctions for leads and on leads performance reporting criteria, for example.

Data collection for this type of use means a dependence on statistical techniques.  Annex A addresses the statistical method for survival analysis, as well as a discussion of the application of the results you’ve obtained.   This includes a clause on the categorization of devices.  And Annex B covers the rationale for the standard, noting the differences in the regulation of patient monitoring information in the U.S. and elsewhere.  An additional 16 references for further review are found in the bibliography.

You’ll want to get a copy of this new ISO standard, and you can order it at the Document Center web store, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be able to get your ISO standards in paper format, for pdf download, or as part of our Standards Online annual subscription service for multi-user access.  Of course, our top-of-the-line notification is included in the price of the document.

Document Center has been providing standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

New ASTM E4 2014 Edition – Force Verification

August 11th, 2014

ASTM E4 has been updated again and you can purchase your copy of the new edition from Document Center Inc. in both paper format and for pdf download.  This standard provides you with the requirements for calibrating a testing machine that includes the measurement of the force of gravity (weight).  Titled “Standard Practices for Force Verification of Testing Machines,” it covers three types of verification methods.  It was last revised in June of last year.

This ASTM standard practice allows you to review and choose from verification by standard weights, by equal-arm balance and standard weights, and by elastic calibration.  It includes a table that shows you how much unit force is exerted by a unit mass in the atmosphere (air) at various latitudes.  Not only does the document provide you with the protocols for each of the three test methods, but it also gives you the requirements for calculations and for reporting.

Additionally, you’ll find an Annex A that provides you with the methodology for verifying the force measuring system outside of the machine you are testing.  And there are two (non-mandatory) appendixes that cover the determination of resolution of the force indicator and identifying and determining the measurement uncertainty components during your force verification process.

Of course, if you use the ASTM E4, you’ll be wondering what the changes are in this new release.  ASTM’s Committee E28 (which authored the standard) has identified two areas where changes were made:  Clause 4.1 was revised and Clause 21.1.5 has been added.  For a more complete way to identify these updates, consider purchasing the redline edition.  For a slight increase in the cost of the document, you’ll get two copies:  One of the new edition as published and another of the previous edition with all the changes marked for easy identification.

You’ll also be pleased to know that the ASTM E4 can be made part of your Standards Online access service from Document Center.  This means that you can have multi-user access during the annual subscription period for the employees at your company.  And any changes that are made to the document during the subscription period are included at no additional charge!

Find out more by contacting our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  And use our webstore at www.document-center.com for all your standards purchases.  You’ll get speedy service and no-charge notification of future changes to your documents.  Make us your Standards Experts!