ANSI/ASA S3.44 Part 1 – Hearing loss

ANSI/ASA S3.44 Part 1, “American National Standard Acoustics – Estimation of Noise-induced Hearing Loss-Part 1: Method for Calculating Expected Noise-induced Permanent Threshold Shift,” has just been released.  It replaces the previous ANSI/ASA S3.44 from 1996 and is the U.S. modified adoption of the ISO 1999 from 2013.  The standard provides a method to calculate the expected noise-induced loss of hearing in adults depending on the noise level and amount of time a person is exposed to noise.

The Secretariat (“Caretaker” or “Standard developer”) for this publication is the Acoustical Society of America (ASA).  As the U.S. TAG (Technical Advisory Group) to ISO for this subject, ASA has the right to adopt and republish any ISO standard that it helps to author.  In this case, ASA found a number of areas where they needed to deviate from the ISO 1999 original.  So here is a list of some the items that are different in the U.S. edition:

  • The ANSI/ASA S3.44 Part 1 reflects the expectation that ASA will be developing and publishing a Part 2, which is not evident in the ISO 1999 since there are no plans for a Part 2 at ISO.  The U.S. Part 2 will include age as a factor.
  • Errors were found in the ISO Tables A.3 and B.2 and in an equation (C.10).  They are noted in the ANSI/ASA edition and should be fixed in the next edition of the ISO 1999.
  • Of course, in this U.S.  Edition, “American National Standard” replaces “International Standard” in the text, decimal points replace the European convention of using a comma, and American English spellings replace the ISO original British English ones.
  • The convention of using data based on a broadband steady non-tonal noise in the ISO 1999 may be replaced with tonal noise for ANSI/ASA users.  This is to accomodate the OSHA regulation requiring a 5-dB exchange rate.

Other changes occur throughout the document.  All are high-lighted by the use of bold blue text within a blue box.

If you use the 1996 ANSI/ASA S3.44, you’ll need a copy of the new ANSI/ASA S3.44 Part 1 from 2016 to replace the older (now-obsolete) edition.  Choose an authorized ASA distributor like Document Center Inc. for your purchase.  You can search for and order standards in both paper format and for pdf download at our webstore, www.document-center.com.  For your convenience, here is a direct link to the order page for ANSI/ASA S3.44 Part 1.

And of course, all ASA standards are also available as part of our enterprise-wide subscription solution, Standards Online.  If you’d like more information about this Document Center service, just contact our staff by phone (650-591-7600) or email (info@document-center.com).  You’ll get immediate assistance to solve your most trying compliance documentation issues.  Make us your Standards Experts!

EN 50600-3-1 – Data Centers in Europe

EN 50600-3-1, “Information technology. Data centre facilities and infrastructures. Management and operational information,” has just been released.  It is yet another in the EN 50600 series on Data Centers meant to set a new standard for efficiency, particularly energy efficiency.  The series will impact those of you involved in the design, planning, procurement, integration, installation, operation and maintenance of facilities and infrastructures for data centers.

Where does the EN 50600-3-1 fit into the EN 50600 scheme?  The other standards in the series deal with specific implementation issues (cabling, security, power distribution, environmental control and building construction).  This new part 3-1 addresses the processes for the management and operation of data centers.  Here is CENELEC’s description of the standard:

“The primary focus of this standard is the operational processes necessary to deliver the expected level of resilience, availability, risk management, risk mitigation, capacity planning, security and energy efficiency. The secondary focus is on management processes to align the actual and future demands of users.”

Who is the target audience for this standard?  It is written for those involved in facilities, whether it be as owners, designers and developers, construction services, and/or equipment suppliers and installers.  It is a European standard to be used as a holistic approach to the challenge of building and maintaining data centers for now and for the future.

What is a data center in terms of the EN 50600 series of standards?   It’s a facility that provides networked telecommunications equipment dedicated to storing, processing and transmitting data.  This includes the infrastructure for power generation and environmental control necessary to maintain high levels of service using this type of equipment.

Data centers have been around for a long time.  Why the EN 50600 series of standards now?  This series is an attempt to bring together information and concepts that have been supplied by a variety of industry associations up to this point (TIA, ANSI/BICSI and so on).  It represents an effort to create a facilities standard for Europe, comprehensive in scope.  It will be used to audit for for energy certification.

How do I get a copy of this standard?  Use an authorized standards distributor like Document Center Inc. for your compliance information.  You can search for and order standards at our webstore, www.document-center.com.  Here is a direct link to the order page for BS EN 50600-3-1, the official English language edition of the EN 50600-3-1.  If you have any additional questions, just get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We’re your Standards Experts!

IEC/TR 80001-2-8 – Medical Device Risk Management – IT Networks

IEC/TR 80001-2-8, “Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2,” has just been released.  It is intended to assist both Healthcare Delivery Organizations (HDOs) and Medical Device Manufacturers (MDMs) implement security controls for data held in networked systems.  It provides guidance for the establishment of “each of the security capabilities presented in IEC TR 80001-2-2.”

Who should be using IEC/TR 80001-2-8?  You should be using this technical report if you’re

  • in charge of selecting controls for a medical device system based on ISO/IEC 27001,
  • implementing commonly accepted information security controls, and/or
  • developing security management guidelines for your organization.

What will IEC/TR 80001-2-8 help me do?  It gives you a detailed set of controls for managing health information security.  And it provides you with health information best practices guidelines.  Using this report will help you ensure that the minimum requisite level of security that is appropriate for your situation will be met.  This is essential to maintaining the confidentiality, integrity and available of personal health information in your possession.

What’s included in IEC/TR 80001-2-8?  The 56-page report starts out with the usual scope, referenced documents, and definition sections.  It then moves directly into the guidance section for establishing security capabilities.  This main body of the  document discusses 19 specific requirements like automatic logoff (ALOF), health data integrity and authenticity (IGAU) and malware detection/production (MLDP).  For each requirement a table is provided that includes information on the applicable standard, the reference within the standard, and the control you’ll need.  The publication concludes with an 11-item bibliography.

When you’re implementing a system that needs input from a number of standards or needs to meet requirements from a number of sources, it can be a challenge to keep them all straight.  This is one reason that you’ll find this technical report to be so helpful.  It consolidates the concept of security capabilities from IEC TR 80001-2-2 with the lists of security controls from a number of standards from a variety of sources.  This will make it far easier for you to map security controls to security capabilities.

Now you need to get a copy of this standard and IEC reminds you to be sure to purchase your copy from an authorized distributor like Document Center Inc.  You can search for and order any IEC standard at our webstore, www.document-center.com.  For your convenience, here’s a direct link to the order page for IEC/TR 80001-2-8.  It’s available to order as a paper copy or for pdf download.  Should you prefer enterprise access, ask our staff about our Standards Online cloud subscription.  You can reach them by phone (650-591-7600) or email (info@document-center.com).

Document Center Inc. has been providing standards to folks like you since 1982.  We have a wide range of services available to support your proper use of this compliance documentation.  Make us your Standards Experts!

IEC/TS 62775 – Implementing Asset Management Systems

IEC/TS 62775, “Application guidelines – Technical and financial processes for implementing asset management systems,” has  just been released.  This new Edition 1.0 provides the technical link between the ISO 5500x suite of standards on Asset Management and the IEC “dependability suite” of standards (e.g., IEC  60300-3-15, etc.).  It shows you how you use the technical details present in the IEC documentation to support the requirements of AMS (Asset Management System) processes.

What are the standards that are addressed in the IEC/TS 62775?  Of course, the main standards series is the ISO 5500x documentation set (like ISO 55001), which specifies the requirements to implement an AMS.  But it also refers to the ISO/IEC/IEEE 15288 which can be used to manage the technical and financial processes themselves.   And it shows you how to use the IEC dependability standard for the technical processes and activities that will be used within AMS.  Finally, it relates the IFRS (International Financial Reporting Standards) suite of financial standards to the actual processes you’ll use within AMS.

Why was the IEC/TS 62775 written?  It was developed because there is no place within the ISO 5500x standards that defines the actual information needed to implement the technical and financial processes that support the management of assets.  Since there are many issues involved in correctly managing assets, this standards brings in all the documentation components and describes how existing technical components can support the proper protocols required by IAS (International Accounting Standards).

The standard starts out with high level discussions of the requirements.  And it discusses each silo of standardization so you can understand how each will fit into your system.  Once you understand the place for each of the suites of standards, you’ll then want detailed information on how they map one to the other.  This is provided in the 3 Annexes.  First, Annex A covers the IFRS and IAS information that’s basic to any asset management scheme.  Annex B maps ISO 55001 to ISO/IEC/IEEE 15288, the actual AMS requirements to the system life cycle process.  And Annex C maps ISO/IEC/IEEE 15288 to the IEC dependability standards as well as to the IFRS and IAS standards themselves.  A 10-item bibliography provides you with details on each of the standards sets used in this publication.

In order to get a copy of this technical specification, you’ll want to use an authorized IEC distributor like Document Center Inc.  Of course, you can search for and order standards from a wide variety of jurisdictions at our webstore, www.document-center.com.  Here is a direct link to the order page for IEC/TS 62775 for your convenience.  It’s available in both paper format and for pdf download.  And of course, it can be included in our exterprise subscription solution, Standards Online.  To learn more about any of our products and/or services, or to place an order, contact us by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

ASTM E18 2016 Update Available

ASTM E18, “Standard Test Methods for Rockwell Hardness of Metallic Materials,” has just been revised.  The new 2016 Edition is available from Document Center Inc. in a variety of formats.  It is a regular entry in our “Top Selling Standards of …” Lists that we publish annually.   It covers the test methods you’ll use to determine the Rockwell hardness and Rockwell superficial hardness of metallic materials.  And it covers both the machines and the procedures for performing these tests.

The Rockwell hardness test is one of the three most commonly used tests of this kind (the others are the Brinell hardness test, and the Vickers hardness test).  This type of testing is used for quality assurance, to confirm that advanced materials will perform as expected.  Parts may be subject to high temperatures and under conditions involving loads and pressure.   Hardness testing is one way to predict the suitability of a material for the expected stress a given part may be expected to withstand.

These tests all measure the depth to which an indenter will sink into a given material.  They are performed at a defined load and within a specified period of time.  And specialized test eqipment is usually used in order to assure repeatability and control during testing.

Your authoring committee E28 has noted that changes have been made in paragraph A3.5.2.5.  I also note that Table A3.6 also appears to have a correction made as well.  A further editorial change has been made to Table 1.

The 38-page standard is available from Document Center Inc. in paper format or for pdf download.  Additionally you can purchase a redline edition that has the changes noted on a separate copy.  And of course, all ASTM standards can be included in our Standards Online company solution.  Just order at www.document-center.com (here’s the direct link to the order page for ASTM E18).  Or contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982 and can help you set up the system you need to best manage this type of compliance information.  Make us your Standards Experts!

 

ISO/TR 19838 – Cosmetic Microbiology

It’s Friday and I often like to use the end of the week to discuss an area where standardization plays an important but rarely considered role.  Ever since Document Center started to have cosmetic companies for clients, I’ve been interested in the standards they use and a new one is available!  It’s ISO/TR 19838, “Microbiology – Cosmetics – Guidelines for the application of ISO standards on Cosmetic Microbiology.”  And since the concept of biological contamination of cosmetics has even made it into the “popular literature” (the kinds of magazines women like me enjoy reading in our spare time!), it’s good to know that standardization is here to support safe products for us.

Cosmetic manufacturers have two concerns when it comes to contamination.  The first, of course, is providing a clean product to the purchaser.  When I buy a cosmetic product at the store I want to know that it is free of any microorganisms that could affect my health or degrade the quality of the product.  But I also want to know that the product is resistant to negative affects that could be caused during normal use as well.

So I’m glad to see that this technical report has been issued.  ISO/TR 19838 gives manufacturers general guidelines to the ISO cosmetic microbiological standards available.  It helps them determine which to use depending on the objective (product development, in-market control, etc.) and the product they need to test.

It has lots of information on tests used to determine microbial content and antimicrobial preservation.   And it also shows users a variety of different approaches to testing that can be made, with examples using eye make-up remover, mascara, face cream, and shampoo!  To wrap up the main body of the standard, examples of test result interpretations are given.

Another great feature of the standard can be found in the Annexes.  These informative sections cover the various ISO cosmetic microbiology standards relate to one another, what aspect of microbial content of cosmetics each standard relates to, the evaluation of microbial content in flowchart form, and the interpretation of test results, also in flowchart format.  A 13-item bibliography completes this 22 page report.

Of course, if you’re in the cosmetics industry, you’ll want a copy of this new Technical Report.  You can search for and order standards at the Document Center Inc. webstore www.document-center.com, an authorized outlet for ISO publications.  And for your convenience, here’s a direct link to the order page for ISO/TR 19838.

Or you may want to get in touch with us directly.  Our staff can be reached by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling ISO standards since the 1980’s.  Make us your Standards Experts!

What are these AAMI TIR Reprints?

We just added 32 AAMI TIR Reprints into our database and we know it’s sure to cause some confusion.  After all, usually AAMI (the Association for the Advancement of Medical Instrumentation) updates include important changes to technical data that the medical device industry relies on.  However, these reprints represent an administrative change which has little to no bearing on the use of these publications.  So here’s what!  Let’s take a look at these reprints and learn what it all means.

First of all, we need a quick review of what an AAMI TIR (Technical Information Report) is.  Unlike AAMI standards and recommended practices, these documents do not go through the usual rigorous development process as required by ANSI (the American National Standards Institute) for adoption.  They are created specifically to meet a critical industry need.  In particular, the requirement for review every 5 years for either reapproval or updating is not mandatory for TIR’s.  They may be left in place if the authoring committee deems the information either to still be valid or to be of historial value.

So, all the documents that have been issued as reprints are actually adoptions of ISO/TR or IEC/TR publications.  AAMI has the right to republish these Technical Reports (TRs) because of its participation in international standards development at the behest of ANSI.  However, at the International level, similarly to the TIR, the TR is not subject to the same rigorous review process as the other publications.  This means they do not meet ANSI administrative process requirements that are critical to release as an ANSI adopted document.

When the 32 AAMI TIRs were originally published, they were given a numerical designation that included “ANSI” in the number.  However, as  you can see above, these reports didn’t actually meet the criteria needed for ANSI approval.  This error in numbering has been brought to AAMI’s attention and has just now been fixed.  Thus, the 32 reprints!

And the changes are (administrative only):

  • “ANSI” was removed from the designation of all 32, including in the footer
  • The title page of each has been updated to read “Registered” by ANSI, rather than “Approved”
  • The text before the table of contents has been revised

There is no change to the guidance within the documents or the page counts at all.

Do you need to purchase these reprints?  The AAMI TIR reprints are administrative in nature.  There is no change to the technical content.  So getting a copy of the reprint is not necessary if you are interested in technical changes only.  However, in cases like this where the document has some type of physical change (for example, reprints with reapproval dates only), some auditors do require companies to have the most current information.  You should review the situation with your company’s compliance staff if you are uncertain how to proceed.

In the meantime, you’ll want to purchase your copies from an authorized AAMI distributor like Document Center Inc.  You can search for and order all the standards you need at our webstore, www.document-center.com.  An easy way to check which items have been revised is to search for “AAMI/IEC TIR” and/or “AAMI/ISO TIR”.  And if you’ve purchased copies of any of these 32 recently reprinted TIR’s from Document Center Inc., you’ll soon get your notification(s).

Need more information?  Want to order directly from Document Center Inc.?  Just contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982 and have the knowledge you need to make the most of this type of compliance documentation.  Make us your Standards Experts!

EN 55011 2016 Edition is here!

EN 55011, “Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement,” has just been updated.  The new 2016 Edition is available now in a variety of national editions, so you have a choice when it comes to getting your copy of this new revision.  It is derived from the CISPR 11, which was updated to Edition 6.0 about a year ago.

Of course, one of the first questions users of the EN 55011 will have is “What is the transition period?”  For this update, you have until 2/15/2019 to transition from the previous 2009 Edition with Amendment A1 (2010).  This means that both editions will be current until that date!

How can I tell where the EN 55011 2016 is different from the CISPR 11 2015?  The EN document states that “Clauses, subclauses, notes, tables, figures and annexes which are additional to those in CISPR 11:2015 are prefixed ‘Z’.”  Additionally, the EN 55011 has an informative Annex ZZ which describes the relationship of this standard with any applicable EU Directives.  And of course, there are additional Annexes that apply to European concerns:  Annex ZA on what European EN standards to use in place of other referenced documents within the publication and Annex ZB on frequencies designated on a national basis within the EU.

What’s new in the technical content of EN 55011 2016?  The changes mirror those of the CISPR 11 Edition 6.0, since this is the source document.  I’ve already reviewed those changes in a previous post from last year.  Here is the link for your review: CISPR 11 News.

How do I get a copy of the new EN 55011 2016?  Since the EN standards must be purchased in one of the many national editions available, you can choose the edition that works best for your purposes.  We have a number of options available for you at our webstore, www.document-center.com.  The official English language edition (BS EN 55011) is available from Document Center Inc. in paper format only.  Here is a link to the order page for BS EN 55011.  You can also purchase this standard in the SS EN 55011 Edition, available in both paper format and for pdf download.  Here is a direct link to the order page for SS EN 55011.

Have more questions?  Just get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982 and have the knowledge that you need to make the best use of these compliance documents.  Make Document Center your Standards Experts!

IPC J STD 001 F + Amendment 1 Consolidated Edition!

IPC J STD 001, “Requirements for Soldered Electrical and Electronic Assemblies,” has been updated with the release of the Revision F with Amendment 1 Interfiled Edition.  It’s available in a variety of formats — Paper, Non-Printing PDF, Non-Printing Single User CD Rom, and the site and global licensed CD Rom options.  Since the Amendment 1 was released as a non-printing pdf only, this gives all J-STD-001F users a chance to get the information in the format that they’re used to.

I have blogged about the changes to the IPC J STD 001 previously (New J-STD-001 F is now available) but I have not reviewed the information in the Amendment 1.  The changes to the J STD 001 mirror those to the IPC A 610.  IPC states that they:

  • Reintroduce the Space Shuttle symbol to show where there are different criteria in the J-STD-001FS, “Space Applications Electronic Hardware Addendum” to IPC J-STD-001F, “Requirements for Soldered Electrical and Electronic Assemblies”
  • Revise the Class 2 requirements for vertical solder fill on plated through holes with less than 14 leads to include requirements when there is a connected internal thermal plane
  • Eliminate requirements for BGA voiding for BGA components with noncollapsing balls

So now this leaves a number of questions.

Do I need to purchase a consolidated edition if I already have the Revision F and the Amendment 1?  No, this consolidated edition is just being released for your convenience.  It does not have any additional technical information beyond what is already in the Rev F and Amendment 1.

Can I return my copy of J STD 001F for credit?  No, unfortunately IPC is not accepting returns on this standard.

What if I didn’t get a copy of the Amendment 1 yet?  You have the option of purchasing the amendment separately or getting the new consolidated edition.  Remember, the amendment is available as a non-printing pdf copy only so you’ll be using the information on 1 computer for 1 person only.

Where can I get my copies of this new release.  Choose Document Center Inc. for your standards purchases.  You can order online at our webstore, www.document-center.com.  Here is a direct link to the order page for the IPC J STD 001 for your convenience.  Have additional questions?  Just get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  You’ll find them to be knowledgeable about the questions you have about the compliance documentation you use.  Make us your Standards Experts!

IPC-A-610 F + Amendment 1 Consolidated Edition!

IPC-A-610, “Acceptability of Electronic Assemblies,” has just been released as a consolidated edition.  This new update provides you with an interfiled copy of the Revision F and its Amendment 1.  And it’s available in a variety of formats:  paper copy, non-printing single user pdf or CD Rom, and the site and global licensing CD’s.  If you’ve been frustrated by the lack of options for getting your copy of the Revision F Amendment 1, this is for you!

Do I need to buy one of these consolidated copies if I already have the Revision F and the Amendment 1?  If you are only interested in the technical content and you’ve managed to integrate the non-printing pdf copy of the Amendment 1 into your system, there’s no technical reason to purchase the consolidated edition.  It has been released for your convenience only.

Can I get any kind of credit towards the new consolidated edition if I already purchased the Revision F and Amendment 1 separately?  No, this is considered to be a completely new issue.  No returns of previous material are being accepted.

Why should I get this new IPC-A-610 F with Amendment 1?  Since the Amendment 1 was only released as a non-printing pdf copy, it’s caused a lot of difficulties for some users.  For example, a company that has the Revision F as a paper copy may have a lot of difficulty making sure that employees are aware of the pdf for Amendment 1 in order to use its changes.  So a consolidated edition in the format you’re used to using is a real plus.

I didn’t get my copy of Amendment 1 yet?  What were the changes?  I have a previous post on just this question.  Check out the changes to IPC-A-610F Amendment 1 here.

Where can I get my copy of this new update?  Use an authorized distributor like Document Center Inc.  Here’s the direct link to the order page for IPC-A-610.

Is it still possible to get copies of the Amendment 1 only?  Certainly.  However do remember, it is still only available in that non-printing pdf format.

And if you need other IPC standards, just head to the Document Center Inc. webstore at www.document-center.com.  You’ll order here with confidence, and receive our best-in-class notification service free with your purchase. More questions?  Just contact us by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards since 1982.  Make us your Standards Experts!