IPC-A-640 Acceptance Requirements for IPC-D-640 Optical Fiber Assemblies

IPC-A-640 has just been released.  This new standard is a companion to the IPC-D-640 on optical fiber, cable and wiring.  The title of the new publication is Acceptance Requirements for Optical Fiber, Optical Cable, and Hybrid Wiring Harness Assemblies.  You’ll use it for cable and wire harness assemblies incorporating optical fiber, optical cable and hybrid wiring technology.  It’s available from Document Center Inc. now in pdf format.

IPC-D-640, Design and Critical Process Requirements for Optical Fiber, Optical Cable and Hybrid Wiring, was released last year.  It’s intended for use by design engineers, manufacturing engineers, and quality engineers.  The 100-page document covers all aspect of design for what’s termed “FOCS,” fiber optic cable systems.  This ranges from design philosophy to choice of materials, assembly, installation, cleaning, documentation, and tailoring.  Appendices provide you with additional information about military applications, verification test methods, and a verification and validation matrix.

The new sister publication, IPC-A-640, has the same basic structure as the IPC-D-640.  It is also intended for the same audience.  However, the standard provides you with detailed acceptance requirements as well as technical insights.  So this is where you’ll find the specifics for each section of the IPC-D-640.

There are extensive color illustrations provided. You’ll be able to see examples of both correct and non-compliant variations for specific component parts.  And you’ll also receive an excel spreadsheet with a verification and validation checklist.

IPC has been moving away from CD Rom distribution in recent years.  Normally new IPC standards are available in both paper and non-printing PDF format.  Sites (and global) licenses can also be purchased.  At this time, only the PDF format and site license are available for this new publication.  Order them from the Document Center Inc. webstore, www.document-center.com.  Here are direct links to the order page for IPC-A-640 single user PDF, the IPC-D-640 paper format, and the IPC-D-640 PDF. Document Center Inc. is an authorized dealer for the IPC standards.

Should you have additional questions, please get in touch with us.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We have been selling standards since 1982 and have the knowledge missing at so many standards outlets.  Make Document Center Inc. your Standards Experts!

AAMI TIR59 helps you meet FDA Part 820 requirements!

AAMI TIR59 has just been released.  It’s titled Integrating human factors into design controls.  It has been developed to provide information on integrating human factors engineering/usability engineering (HFE/UE) into the design controls process for medical devices.  It directly addresses the FDA requirements in 21 CFR Section 820.30 for design controls.  This technical information report can assist you in creating consistent and aligned processes throughout your product development cycle.

Two important things to note about the AAMI TIR59.  First, it proposes a methodology that can be integrated into existing processes.  Secondly, it includes information on risk management implications at the end of  each clause.  And as a technical information report, the document provides recommendations only.  Other solutions are entirely possible.

Additionally, IEC 62366-1 (ANSI/AAMI/IEC 62366-1:2015) mandates a Usability Engineering File.  So the AAMI TIR59 also focuses on activities that overlap both sets of requirements.

The standard begins with the usual scope and definitions sections.  Acronyms are also given a section as well.  Next, the report reviews the integration of HFE/UE with existing design controls.  Pre-design controls are also discussed.

With Section 6, clauses of the 21 CFR 820.30 are each identified and reviewed with suggestions for compliance.  These TIR59 sections include the FDA 820.30(a) through 820.30(j).  The final section of the publication is on post-market surveillance.  Annex A is informative, and gives you specific suggestions for your HFE/UE report.  These are on development, organization and content, and other considerations.  A 14-item bibliography completes the document.

I find it reassuring that the human element (users) of medical device design is now getting additional attention.  I have met folks whose devices contain a high degree of interactivity.  They can be challenged by tasks that may seem simple for the device manufacturer but present problems when the user has deviations from a routine.  I’m sure there are many other examples of issues that have occurred as our concepts of what medical devices are and do have expanded.

To get your copy of this AAMI technical information report, head to the Document Center Inc. webstore at www.document-center.com.  Document Center is an authorized distributor of the AAMI standards and provides free update notification as part of your standards purchase.  Here is a direct link to the order page for AAMI TIR59 for your convenience.

If you have additional questions or need help ordering, please get in touch with us.  You can contact us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982.  We are very familiar with your compliance needs and have a number of products and programs to assist you with your requirements.   Make us your Standards Experts!

BS EN Standards and Brexit

Before I headed off to a week’s worth of U.S. and International standards meetings in Chicago earlier this month, I spoke with one of our Document Center customers.  What question came up yet again?  What’s the status with BS EN Standards and Brexit!  This was one of my top questions for my friends from the U.K. and Europe and I expected a definitive answer.  But no!  The way forward is still murky.

As expected, the official BSI (British Standards Institute) position has been that continued involvement with CEN and CENELEC is not in question.  However, there are some increasing concerns on the horizon.  These concerns will not make themselves evident until the shape of the political solution becomes more clear.

Here is the problem.  The rules of CEN and CENELEC have certain requirements for National Standards Bodies (NSBs), one of which differs slightly in the three official national language editions of the rules.  BSI has been reading this rule to mean that they could continue to the the U.K. National Standards Body (NSB) even without membership in either the EU or the Efta/EEA (the trade focused auxillary body that allows Iceland, Liechtenstein and Norway to participate).  Now it is starting to look like this will not work.  Revision of the rules may be necessary.  And any change requires a yes vote by 100% of the CEN/CENELEC membership.

This could mean trouble for BSI.   The fallback position would be to move to the adoption of ISO and IEC standards, counting on equivalence to pave the way for smooth trade with the continent.  Meantime, a host of questions immediately come up.  Who would be responsible for the official English language editions of the EN’s?  Would existing copies of the BS EN standards remain valid or be withdrawn?  OK, this could be a major headache for all involved.

Meantime, there are wider issues at hand for the U.K. regarding trade and technical specifications and standards.  To learn more about considerations being reviewed within the U.K., take a look at this interesting paper.  It’s Brexit Paper 14 generated by the Bar Council Brexit Working Group.  you’ll come away with the distinct impression that this has all opened up quite a can of worms!

Here at Document Center Inc., we’ll try to avoid the whiplash that comes with making predictions regarding “soft” and “hard” Brexit.  Even the British themselves will not know how this story ends until a political solution becomes clear.  The fate of BS EN Standards and Brexit itself still remain to be seen!

If you need to purchase EN standards, take a look at the Document Center webstore at www.document-center.com.  You will find a number of national editions of the various publications.  All are valid for your organization.  Any further questions?  Just get in touch with myself or our staff by phone (650-591-7600) or email (info@document-center.com).  Thank you.

ANSI Z245.1 2017 Released for Garbage Truck Safety

ANSI Z245.1 has just been updated and the 2017 Edition is available from Document Center Inc. now.  The update is titled Mobile Wastes and Recyclable Materials Collection, Transportation, and Compaction Equipment – Safety Requirements.  This morning was our garbage collection day and I followed our garbage guy down the street as I was heading to work.  I’m probably showing my age, but garbage collection is radically different today than when I was a kid.  As I watched the “arms” of the truck grab my neighbors trash cans (and tip one over I might add), I marveled at the changes in the industry.

But with all the additional equipment now on-board, garbage truck safety has got to be a big concern for both truck manufacturers and waste disposal companies.  Here is where ANSI Z245.1 comes into play.  The document addresses equipment safety requirements for equipment for mobile trash collection, including recyclables.  It revises the previous 2012 Edition, which is now obsolete. You’ll need to use the new edition moving forward.  Old equipment does not need to be retrofitted.  Note: the provision amendment for the 2012 Edition (concerning fall protection) is still in force.  Let us know if you need a copy.

ANSI Z245.1 is appropriate for use by those who manufacture, reconstruct or modify, operate, clean and maintenance, service or repair mobile collecting, transporting, and compacting equipment.  It does not address requirements for equipment used for hazardous or flammable materials.  A wide variety of equipment is covered by the standard.  They range from the usual garbage trucks you see in your neighborhood to trailers used to transport waste from one location to another, to satellite vehicles for receiving and transporting waste.  Those “arms” that I spoke of are also covered by this document.

For those of you who like pictures included in your standards, there are plenty of figures in this one!  For example, Table 8.1 provides you with safety signage requirements.  Columns include a reference number, the specific hazard, where the signage should be placed (location), size, font size, and the ANSI warning label to be used.

With 2.12 billion tons of trash being generated globally each year, you can understand why trash collection equipment, including recycling capabilities, are so important.  At the beginning of the publication, you’ll see the wide range of participation that the National Waste and Recycling Association (the caretaker of this standard) was able to achieve.  It’s clear that the industry is moving quickly to support societal needs with regards to improved collection, recycling and disposal of waste.

To get your copy of the ANSI Z245.1 2017 Edition, please go to the Document Center Inc. web store at www.document-center.com.  We have worked with ANSI for many years and are an authorized distributor of the Z245 standards.  Here is a direct link to the order page for ANSI Z245.1.

You may have additional questions or need help identifying and purchasing the standards you need.  Document Center Inc. offers you the knowledgeable assistance so often missing in our online world.  Get in touch with us by phone (650-591-7600) or email (info@document-center.com). We respond quickly to your requests and are happy to help you.  Make us your Standards Experts!

Oh! And about that tipped can…  It was clear that our garbage collector was in a hurry this morning, since he skipped a couple of houses after his unsuccessful effort to grab the one he toppled.  Standards developers can only do so much, I’m afraid!

 

IFAN – The Place for Standards Users

Last week in Chicago, I attended my first IFAN meeting.  IFAN is the International Federation of Standards Users.  I am now the U.S. and Canadian representative through my participation in SES (the Society for Standards Professionals).  I found the meeting and the participants to be very interesting and am happy to find myself a part of this organization.  I’d like to tell you more about it and it’s goals.

IFAN was founded in 1974, when 11 national standards organizations met in Paris for an International Conference.  It’s an NGO, now based in Geneva.  Membership is comprised of national standards users groups from various jurisdictions, corporate members, academia, standards experts, and so on.  It is governed by an elected Board of Directors and holds meetings around the world.

IFAN has MOU’s (Memoranda of Understanding) with ISO, IEC, CEN, and CENELEC.  This means that IFAN members can participate in those organization’s general assemblies.  IFAN is also a liaison organization for participation in CASCO, the policy developing committee for conformity assessment.  This group oversees such standards as the ISO/IEC 17025 and ISO/IEC 17030.  Because of these agreements, IFAN members have a chance to directly participate in ISO, IEC, CEN and CENELEC projects of interest to them.

Of course, working at the International level is of great benefit to any person interested in trends in standardization.  And with the access to the folks at the top level of standards development, IFAN members have a chance to influence the direction of standards activities.  IFAN develops positions on subjects that affect standards users around the world.  It is at the table for the development of such strategic activities as the ISO Standards for a Sustainable World plan.

Another feature of IFAN is it’s work in promoting participation for developing and non-developed economies.  The organization is seeing increased participation from a number of locations in Asia and even from Africa.  Involvement for these folks can help them integrate more quickly into the global economy.

Many companies need assistance with their standards understanding and application.  The interaction between standards and regulation is coming into focus as a mood of deregulation sweeps through a number of jurisdictions.  Involvement with IFAN can provide you with a forum for improving your understanding of global standards concerns.  You’ll also learn of developments outside your home country.  And you’ll have a place to voice your requirements and interests at the top level.

I hope you’ll let me know if you have any issues you’d like me to bring to the attention of this group.  And I urge you to consider participation as well!  Just get in touch with me through my company, Document Center Inc.  Emails sent to us at info@document-center.com will reach me.  I look forward to hearing from you.

ASTM E1354 Heat and Smoke Testing

ASTM E1354 has just been updated and the 2017 Edition is available from Document Center Inc. now.  The standard is titled Standard Test Method for Heat and Visible Smoke Release Rates for Materials and Products Using an Oxygen Consumption Calorimeter.  It has been frequently updated, making it a great candidate for inclusion in our Standards Online cloud-based enterprise solution.

I attended the SES conference in Chicago last week and one of the most enjoyable things we did is take a tour of UL headquarters.  We put on our safety goggles and watched UL employees do a wide variety of tests.  I really enjoyed seeing the test instruments and the tests themselves, since I only know them by the various documents we sell.  You can bet, there was a lot of smoke, fire, and explosions during the tour!

The ASTM E1354 is just one of the many ASTM standards routinely used for fire testing.  It is specifically designed to determine ignitability, heat release rates, mass loss rates, the effective heat of combustion, and visible smoke development of materials and products.  This is provided by measuring oxygen consumption, the flow rate in the exhaust, mass loss combined with heat release, and the obscuration of light.

Changes in the new 2017 Edition include updates to sub-clauses 10.2.1.1 and 10.2.1.3.  Sub-clause A1.4.1.1 on CO2 analyzer delay time was added to the Annex A1, which is a mandatory part of the standard.  Also, sub-clause 8.1.6 on samples for asymmetrical products was added.

I mentioned that users of ASTM E1354 should consider purchasing this document as part of our Standards Online subscription.  Why?  This annual subscription provides you with all revisions of the standards you include at no additional charge.  So you not only get company-wide access to your critical standards, you also have confidence that your copies are always up-to-date.

If you’d like more information, contact us by phone (650-591-7600) or email (info@document-center.com).  You can also order the ASTM standards you need at our web store:  www.document-center.com.  Here is a direct link to the order page for ASTM E1354 for your convenience.  Document Center Inc. has a wide array of products and services to solve your compliance documentation requirements.  Make us your Standards Experts!

 

ISO 21930 2017 – EPDs for Construction

ISO 21930 has been updated.  The new 90-page 2nd Edition is available now from Document Center Inc.  It’s titled Sustainability in buildings and civil engineering works – Core rules for environmental product declarations of construction products and services.  It’s used by the building sector to provide information about the environmental aspects of construction works.

These types of communications are called Environmental Product Declarations (EPDs).  As part of the suite of ISO standards available on building sustainability, this document specifically addresses environmental impacts only.  It also complements ISO 14025 since it covers the EPD for construction products and services.

EPD’s require the compilation of information related to the environmental performance of a building or other construction work.  So you’ll need to first develop the information for the EPD, then create a report with the necessary details.

The ISO 21930 begins with the usual scope, referenced document and definition sections.  That’s followed by a list of abbreviated terms.  With Section 5, the core requirements begin.  This section is on the general aspects, including information on objectives, life cycle stages and so on.  Next the standard reviews PCR (Product Category Rules) development and use.  Section 7 addresses LCA (Life Cycle Assessment) with a review of the methodological framework, inventory analysis, and impact assessment indicators you’ll be using.  Section 8 covers additional environment information needed in the EPD.

Now that all the information’s been gathered, Section 9 moves into the content of the EPD itself.  And Section 10 covers the project report.  Verification and validity of the EPD is defined in Section 11.  There is 1 normative (required) Annex, as well as 4 informative ones.  They review various concerns like the release of dangerous substances, environmental indicators from the LCA, and so on.   A 41-item Bibliography completes this standard.

Those of you already using the ISO 21930 1st Edition will want to know what the changes are.  The 2nd Edition is a technical update, replacing the now-obsolete 1st Edition.  Changes are extensive.  Review the list from the committee in the forwarding material on pages v and vi.  These changes will definitely impact your use of the standard.

Now to get a copy.  Use an authorized distributor like Document Center Inc. for purchasing all of your standards.  They are available through our website, www.document-center.com.  Here is a direct link to the order page for ISO 21930 for your convenience.

You may need additional information or want to set up a subscription service so your entire company can access the standards import to your business.  Reach out to us by phone (650-591-7600) or email (info@document-center.com) for assistance.  We have been working with standards since 1982.  Look to us for the compliance solutions you need and make us your Standards Experts!

 

EN 55011 Updated

The use of the EN 55011 is widespread.   The standard is titled Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement.  It is a harmonized standard for the 2014/30/EU Directive on Electromagnetic Compatibility.  It recently was updated with the addition of an Amendment 1 for the 2016 Edition.  This update replaces the previous 2016 Edition.  The changes to the document were generated by changes in the source standard.  Since it is an adoption of the CISPR 11, the new EN 55011 now includes the CISPR 11 Amendment 1.

The standard is part of the harmonized standards series for the EMC Directive, 2014/30/EU.  However, the new edition is not on the list yet.  This means that it has not been officially adopted in the Official Journal.

I note that this approval may be pending due to issues with the Annex ZZ.  The Annex references the clauses of the previous (now withdrawn) EMC Directive 2004/108/EC.  However, the CENELEC information on the document states that while the previous 2016 Edition related to both Directives, the new 2016 Edition with the 2017 Amendment is for the 2014/30/EU only.  I suspect this may have resulted in some cases of the various editions having different status levels in different nations.  I note that at the present time, the BS EN 55011 2016 Edition is considered withdrawn without replacement.  However, the new BS EN 55011 2016 + Amendment 1 2017 is current.

If you use this standard, please note that several national deviations are presented in the cover sheet material.  Some frequency ranges are different in Germany and in the United Kingdom.

You may also be interested in the changes from the previous 2016 Edition.  Updates have to do with the the fully-anechoic room (FAR) for measurements of the disturbance field strength.  (A FAR is a shielded enclosure where the internal surfaces are lined with RF energy-absorbing material.)  The new FAR requirements are for disturbance field strength in the range of 30 MHz to 1 GHz.  This FAR can be used if validated according to CISPR 16-1-4.

You do have choices when it comes to your purchase.  Use the Document Center Inc. website at www.document-center.com to see your options.  Or contact us by phone (650-591-7600) or email (info@document-center.com) for more information.  We have a variety of standards solutions available for you.  Make us your Standards Experts!

 

ASTM E18 2017 Rockwell Hardness

ASTM E18, Standard Test Methods for Rockwell Hardness of Metallic Materials, has been revised again.  The new 2017 Edition is available from Document Center now.  It is a copyright document and can be purchased in paper format or for pdf download.  It can also be included in our Standards Online cloud access subscription service.

This is one of our best selling standards here at Document Center Inc.  I last blogged about it when the 2016 Edition was released (ASTM E18 2016 Update Available).  It provides you with the test methods to use to determine the Rockwell hardness and the Rockwell superficial hardness of metallic materials.

You will also find complementary information in the Appendices.  Appendix X1 is a list of ASTM standards that give approximate hardness values corresponding to tensile strength values.  Appendix X2 contains examples of procedures for determining Rockwell hardness uncertainty.

The changes in the new 2017 Edition of the ASTM E18 are not extensive.  They center on a new Note A1.4 and changes in Clauses A1.5.2.8, A1.5.3.9, A2.8.1.8 and A2.8.2.9.  However, you may have trouble spotting them.  Use the Redline edition to confirm all updates.  It costs a bit more, but you not only get the clean copy of the 2017 Edition but also the “marked-up” copy of the 2016 one as well.

Copyright standards should always be purchased from an authorized distributor like Document Center Inc.  Search for current and obsolete editions of ASTM Standards at our webstore, www.document-center.com.  It’s easy to order online.  Here is a direct link to the order page for ASTM E18 for your convenience.

Have other questions?  Just reach out to us by phone (650-591-7600) or email (info@document-center.com).  Document Center has been working with standards since 1982.  We have a wide range of products and services to support your document control function. You’ll quickly learn why so many companies make us their Standards Experts!

ANSI/AAMI/ISO 25539-1 2017 Released

ANSI/AAMI/ISO 25539-1 has just been updated.  The new 2017 Edition is available from Document Center Inc. in both paper format and for pdf download.  The title is Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses.  It is the U.S. national adoption of ISO 25539-1 from 2017.

What is a national adoption of an ISO standard?  It is an authorized reprint of an international standard.  It may be a translation from the original ISO text.  For U.S. adoptions, the spelling is modified to support American conventions from the original British.  In the case of AAMI, these national editions are possible because AAMI is the U.S. TAG (Technical Advisory Group) participation in the writing of ISO and IEC standards for medical devices.  Many times national adoptions are less expensive, since all the proceeds go only to the publisher and do not have to be shared with ISO.

Where is the ANSI/AAMI/ISO 25539-1 an authorized edition?  Normally national adoptions are for use in the country where they are published.  With medical device standards, there are other regulatory concerns.  Many of these AAMI adoptions are called out for FDA compliance.  So the use of the U.S. adoptions may be required for medical devices manufactured and/or sold in the U.S.

How do I know if ANSI/AAMI/ISO 25539-1 is required by the FDA?  This publication has just been released.  It will take a while for the FDA to review it and determine if there are national differences necessary for U.S. compliance.  To find out the status for a document in the U.S., go to the FDA Recognized Consensus Standards Search Page.  Put the document number only in the standard designation search field.  The results of the search will show you what document editions are authorized by the FDA.

In the case of the 25539-1, currently the previous ISO edition is in force.  This means that right now, the FDA requires you to meet the ISO 25539-1 1st Edition (2001) with Amendment 1 (2005).  I would expect this to be updated with information on either the ISO 25539-1 2nd Edition (2017), the ANSI/AAMI/ISO adoption (2017) or both.

To get a full run-down on the changes in the new 2017 Edition, take a look at the Introduction on Page viii.  Here the committee has provided you with an “executive summary” of the updates.

To get your copy, use Document Center Inc.  We’ve been selling standards since 1982 and we are an authorized AAMI distributor.  Go to our webstore at www.document-center.com or directly to the order page for ANSI/AAMI/ISO 25539-1.

If you’d like more information on our other products and services, get in touch with us.  We can be reached by phone (650-591-7600) or email (info@document-center.com).  Our customers rely on us to support their compliance documentation requirements.  Make us your Standards Experts too!