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!

ISO 6658 Revised – Sensory Analysis

ISO 6658 3rd Edition has just been released.  It’s titled Sensory analysis – Methodology – General guidance.  It provides you with information on the use of sensory analysis for foods and other products.  This new 3rd Edition from 2017 replaces the previous 2nd Edition from 2005.  All the earlier editions are now obsolete, as the 3rd  Edition is a technical update.

Here are the main areas that ISO 6658 covers.  It includes background information on the essential features of the various methods used.  It provides details of the general requirements, procedures and interpretation of results for these types of tests.  And it shows you how to review these tests to choose the one most suitable for your situation.

The standard first starts with the usual scope, reference documents and definitions sections.  The committee requests that you then review Clause 4 on general requirements before moving on.  Clause 5 covers the various tests that can be used.  And Clause 6 takes a look at some general principles of data collection and analysis with regards to sensory data.  General principles of statistical treatment of your results is also included.  Clause 7 covers the test report.  Annex A reviews statistical terms.  A 28-item bibliography completes this 34-page document.

Changes in this new edition include updates to the definition of “sensory analysis”, to Clause 6 and to the bibliography.  Tests were added/expanded in sections 5.2.7 and 5.4.  And Table A.1 was deleted from Annex A.

Most standards on sensory analysis are released by ASTM and ISO.  (Many are then adopted by other jurisdictions).  To take a look at the standards currently available, please see our Document Center Inc. List of Standards on Sensory Analysis.

You can purchase all these standards at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 6658 for your convenience.  You will have the choice of paper format or pdf download.  If you’d like to have the document included in our Standards Online cloud access subscription service, please get in touch with our staff.  We can be reached by phone (650-591-7600) or email (info@document-center.com).

Document Center Inc. has been selling standards since 1982.  We have a wide variety of products and services to support your compliance and corporate requirements.  Make us your Standards Experts!

EN 55014-1 2017 – Radio-frequency Emissions

EN 55014-1 has just been updated.  The new 2017 Edition is available from Document Center Inc. now in a variety of national editions and formats.  It replaces the previous 2006 Edition.  The title is Electromagnetic compatibility. Requirements for household appliances, electric tools and similar apparatus. Emission.   It is the European adoption of CISPR 14-1.

What does this standard cover?  It provides requirements that apply to the emission of radio-frequency (RF) disturbances by appliances, electric tools and other equipment.  The frequency range addressed is 9 kHz to 400 GHz.  The equipment many be powered by AC, DC, and even batteries.

Is EN 55014-1 the same as CISPR 14-1?  The document is the adoption of CISPR 14-1 Edition 6.0 and it’s Corrigendum 1.   Another thing to note is that the CISPR 14-1 references a number CISPR and other international standards.  When using the EN 55014-1, you will be required to use the EN adoptions of each.  A list is included in the Endorsement notice on page 2 and in Annex ZA on pages 3 and 4.

When do I have to use EN 55014-1?  The document is for the manufacture and sale of goods within the European region.  It is part of the harmonized standards list for the Directive 2014/30/EU (on Electromagnetic Compatibility).

How can I get a copy of EN 55014-1?  While the EN 55014-1 was adopted by the European Union back in April, the national editions are just coming out now.  And you can only purchase this standard in a national edition.  Currently, Document Center has the BS EN 55014-1 and the SS EN 55014-1 available for purchase.  They both have the same legal weight and are valid for use in Europe.  Other national editions may currently be available or will soon follow.  Here is the order page for all EN 55014-1 standards on our website.

Do I have to purchase EN 55014-1 in order to get a copy?  Yes, you do.  All national editions are covered by copyright and should be purchased from authorized distributors like Document Center Inc.  Each national standards body does have it’s own set of purchase requirements.  So pick an edition in the format you want and for the price that suits you best.  If you have a specific auditor for certification, that may also factor into your purchase decision.

Still have questions?  Please get in touch with us.  We are knowledgeable about standards and will be happy to help you.  Reach us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982.  Make us your Standards Experts!

 

 

ASTM D1000 Revised for Electrical Tape

ASTM D1000 has just been updated.  The publication is titled Standard Test Methods for Pressure-Sensitive Adhesive-Coated Tapes Used for Electrical and Electronic Applications.  The new 2017 Edition replaces the 2010 Edition, which is now obsolete.  Both are available from Document Center Inc.

The ASTM D1000 contains test methods used for adhesive-coated tapes used in electrical insulation.  These tapes may have backings that are either elastomeric or non-electomeric.  There are 24 different test methods in the publication.  They include flammability, accelerated aging, adhesion strength, curling and twisting, and oil resistance, just to name a few.

There are a great many revisions in this new update.  In fact, the end of the publication does not include the usual synopsis that is often included in ASTM updates.  So your best bet is going to be purchasing the redline edition of this standard.  You will then receive a clean copy of the 2017 Edition and a “marked-up” copy of the previous 2010 Edition.  The changes will be clear to you on the marked-up (redline) copy.

You may have questions on the best way to order ASTM standards.  Document Center provides them in a variety of formats.  These include paper, pdf download (single user), redline (as noted above), combo (paper and pdf set), and subscription access for your entire company (Standards Online).  For more information to help you decide what works best in your situation, get in touch with us.  We’re available via phone (650-591-7600) and email (info@document-center.com).

Many people prefer just to order online at the Document Center webstore, www.document-center.com.  Here is a direct link to the order page for ASTM D1000 for your convenience.  Please note:  We have many obsolete ASTM standards available as well.  If you need a historical copy, please get in touch.

Document Center Inc. has been selling standards since 1982.  We have many products and services to support your document control processes.  Make us your Standards Experts!

EN ISO 80369-7 for Medical Device Connectors Released!

EN ISO 80369-7 has just been released.  It’s the European adoption of the ISO 80369-7.  The title is Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications.  This EN edition replaces the EN 1707 and the EN 20594-1.  You can get your copy in a variety of national editions now from Document Center Inc.

The European edition has the unique feature of mandating the use of EN adoptions of all ISO or IEC standards referenced in the ISO 80369-7.  Other than that, the text of the ISO 80369-7 from 2016 has been adopted without any further modifications.  However, you will also find an Annex ZA in the document.  This provides you with a relationship table for the standard and the Directive 93/42/EEC (the Medical Device Directive).  The table goes through the essential requirements of the directive item by item and shows you the clauses of EN ISO 80369-7 that fulfill the requirement.  Notes for each item are included.

The EN ISO 80369-7, like the ISO 80369-7, provides you with dimensions and requirements used in design and performance for small-bore connectors used in intravascular applications or hypodermic connections for medical devices and accessories.  The document was developed to address the problems arising when connectors for multiple applications are the same.  Now these particular small-bore connectors will only “mate” with others of their own kind.   They will not be able to  mis-connect with other small-bore connectors with other functionalities.

The standard is arranged in the usual fashion, with scope, referenced documents, and definitions provided in the first 3 clauses.  General requirements are then given.  Section 5 addresses the dimensional requirements for luer connectors.  The body of the standard is completed with Clause 6 for performance requirements.

A series of both informative and normative Annexes then follows.  These cover the rationale and guidance for the standard, luer connectors, reference connectors, and the types of medical devices with connections that are covered by the publication.  Annex E gives you a summary of the usability requirements for these luer connectors.  Annex F is a summary of the design requirements.  And Annex G summarizes the assessment of the design of the connectors.

Annex H is interesting.  It is a table with the correspondence of the essential principles set forth in ISO 16142-1 and the clauses or ISO 80369-7.  Annex I is an alphabetical list of the defined terms which references the source ISO standard where the terminology originates.  A 29-item bibliography completes this document.

When working with EN standards, it is important to note that they are only publicly available in national editions.  And you’ll have many of them to choose from!  Here is a listing of some that you can purchase from Document Center Inc. – EN ISO 80369-7 Standards List.  The list will grow as additional publications are made available.

If you have more questions about this, please get in touch with us.  You’ll find our staff to be knowledgeable about the standards you use.  And we have a wide array of products and services to support your compliance requirements.  Reach out to us by phone (650-591-7600) or email (info@document-center.com).  Then make us your Standards Experts!

ISO/TR 10993-22 for Nanomaterials Released

ISO/TR 10993-22 has just been released.  It’s titled Biological evaluation of medical devices – Part 22: Guidance on nanomaterials.  This important new addition to the 10993 series is available now from Document Center Inc.  It can be purchased in paper format, for pdf download, and as part of our enterprise Standards Online subscription service.

Nanomaterials are bringing revolutionary new properties to many product lines.  These materials will surely have an impact on the medical device industry.  However, potential toxicity issues must be addressed.  ISO/TR 10993-22 provides you with guidance on how to proceed.

What are nano-objects (the particles of nanomaterial addressed in this technical report)?  These are particles having a length range from 1 nm to 100 nm.  Since medical device manufacturers will have various points in the lifecycle where folks will come in contact with these objects, risk evaluation needs to address a number of situations.  These include preparation, use, wear, or degradation of the device.

Who should be using the ISO/TR 10993-22?  Medical device industry individuals with training in medical device evaluation will find this report to be essential. This is because nanomaterials have specific challenges during the testing process and when evaluating results.

What’s covered in this report?  It provides you with an ISO 10993 risk management process for medical devices that contain, generate or are composed of nanomaterials.  After the usual scope, referenced documents, and definition sections, general principles are reviewed.  The report then moves on to the physicochemical characterization of nanomaterials.   This is to determine the chemical composition, the physical description and extrinsic properties.

Section 6 covers the preparation of samples.  While many of the requirements are in ISO 10993-12, there still are special concerns with regards to nanomaterials.  The next several sections cover additional considerations.  These include the release of nano-objects from medical devices, toxicokinetics and toxicological evaluation.  Section 10 shows how to present the characterization and test results.  Section 11 specifically addresses risk assessment.  The biological evaluation report is reviewed in Section 12.  A lengthy 272-item bibliography completes the 68-page document.

If you’re using or considering using nanomaterials in your medical device(s), you’ll want a copy of this new publication.  Choose Document Center Inc. for your purchase.  We are an authorized distributor of the ISO standards.  Find them at our webstore, www.document-center.com.  Or go directly to the order page for ISO/TR 10993-22.  Here is a complete list of the ISO 10993 series standards.

Document Center Inc. has been working with standards since 1982.  You’ll find our staff to be knowledgeable.  And we have a wide range of products and services specifically designed to address your compliance concerns.  Reach us by phone (650-591-7600) or email (info@document-center.com).  Make us your Standards Experts!

ASTM A967/A967M Updated – Chemical Passivation

ASTM A967/A967M has just been updated with the release of the new 2017 Edition.  This specification is a best seller here at Document Center Inc.  The title is Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts.  This new revision replaces the previous 2013 Edition, which is now obsolete.  (For more information on the old edition, please see my post from 2013:  New ASTM A967/A967M 2013 Edition).

The specification covers a number of chemical passivation treatments for stainless steel parts.  You’ll be given recommendations (and precautions) for descaling, cleaning and passivation.  To confirm effectiveness, several alternative tests are provided.

Changes to ASTM A967/A967M 2017 are extensive.  Here are the areas that the committee has highlighted for your review:

  • Section 4 has been expanded
  • Subsection 5.2.1 is revised
  • Note 2 has been added
  • The use of “supplier” replaces all references to “seller” and “processor”
  • Alternatives to immersion are now provided in 6.1.1 and 7.1.1
  • Dry time has been modified in 14.1.2
  • The cleaning and drying requirement for 14.2.3 is now to be found in X2.10
  • The restriction on copper sulfate test for food equipment in 14.4.1 is removed
  • Procedures in 14.4.3 and 14.5.3 have been expanded and Section 14.7 is added
  • There’s a new Appendix X2 (it includes X1.3.2 through X1.3.4 and X1.12)
  • X1.3.1 through X1.3.4 have been added (from QQ-P-35 Revision C).  This includes corrections to Table X1.1

For more specific information on these changes, get a redline edition when you make your purchase of this copyright publication.  You’ll get a second copy of the specification with all the changes clearly marked.

Speaking of getting a copy, you should use the Document Center Inc. webstore for your purchase.  As an authorized dealer of these standards, we have all the current and many of the obsolete editions available at our webstore, www.document-center.com.  Here is a direct link to the order page for ASTM A967/A967M for your convenience.

You can purchase these standards in both paper format and for pdf delivery.  And they can all be included in our enterprise cloud subscription solution, Standards Online.  To find out more about your many options, get in touch with us by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards since 1982 and have many products and services for keeping your compliance documentation in good shape.  Make us your Standards Experts!