ISO 3950 Updated – Dentistry Designation System

ISO 3950, “Dentistry – Designation system for teeth and areas of the oral cavity,” has just been updated.  The new 4th Edition replaces the previous 3rd Edition from 2009.  It is a technical update.  You can purchase your copy of this new revision from Document Center Inc., an authorized distributor of ISO standards.

So I’m heading over to my dentist’s office tomorrow morning for my bi-annual teeth cleaning.  What does my dentist see when he looks at my teeth?  And how does he and his office store that information?  This is the territory of this ISO 3950 designation standard — It provides common terms and a numeric system for storing and communicating data regarding the health of my teeth!

The standard has been in force for some time (since its first release in 1977) but with the heavy usage of computers in the healthcare setting, new basic elements to this system have been added.  So much to my surprise, it turns out that when my dentist looks in my mouth, he records what he sees as a series of numbers!  And ISO 3950 is the standard for that numeric system.

What information is communicated in this way?  First, it gives you the designations for the areas of your “oral cavity” (mouth).  Then it assigns numeric values to each of your teeth (and any you have lost over time as well!).  When all is done, it turns into a numeric map of your mouth, nicely charted in figure 1.  And if, like me, you don’t really understand all the terminology involved in mapping your mouth this way, the standard references ISO 1942 on the vocabulary of dentistry.

If you’re involved in dentistry or in supplying software used in dentistry, you’ll want a copy of this updated standard.  Head to the Document Center Inc. webstore, www.document-center.com, where you can search for and order standards from around the world.  Here is the direct link to the order page for ISO 3950.  It is available for you to order in both paper and pdf format.  Should you prefer company-wide cloud access, get in touch with us for a quote on our Standards Online service.  We can be reached by phone (650-591-7600) and by email (info@document-center.com).  Remember, we’re your Standards Experts!

ISO 16016 Updated – Protecting your IP

ISO 16016, “Technical product documentation – Protection notices for restricting the use of documents and products,” has just been updated.  The 2nd Edition released this month is now available from Document Center Inc. in a number of formats.  It covers various symbols and language you can use to protect the IP that is imbedded in your technical product documentation and other documents.

Of course, your documentation can often contain specific details of your products that are proprietary.  This is why company standards are rarely publicly available.  Even so, you’ll forward these specs and other information to your suppliers with regularity.  How do you communicate the fact that the information contained in your documentation is “confidential?”

ISO 16016, 2nd Edition, covers the spectrum of tools you can include in the text of your material.  These tools include symbols for trademark, copyright, protected topography (semiconductors), patents and design.  But the standard also includes specific wording you can use to additionally alert people to the responsibilities required when using your documentation.  This is provided in a simple one-paragraph statement, concise and to-the-point.  Not only that, but the text of this protection notice has been translated into 15 additional languages in Annex A.

In today’s global environment, educating your vendors on the correct handling of your documentation is essential.  This means spelling out in writing (at the very least) the need for careful handling of your proprietary information by prohibiting reproduction, distribution and utilization of your IP.  This standard will help you set up guidelines on the usage of both symbols and disclaimers for your documentation authors to include in all your sensitive publications.

How do you get your copy?  Use an authorized distributor like Document Center Inc.  We’ve been selling ISO standards under contract since the early 1990’s.  So you can search for and order them at our webstore, www.document-center.com.  Here’s a direct link to the order page for ISO 16016.

Of course, you may have additional questions or need company-wide access to this and other standards.  Get in touch with our staff by phone (650-591-7600) or email (info@document-center.com) to learn more about Standards Online multi-user access and our other compliance services.  We’re here to help you so make us your Standards Experts!

ASTM D1929 2016 – Ignition Temperature Test for Plastics

ASTM D1929, “Standard Test Method for Determining Ignition Temperature of Plastics,” has just been updated.  The new 2016 Edition is available from Document Center Inc. in a variety of formats.  It is a fire test response test that shows you how to determine the flash ignition temperature and the spontaneous ignition temperature of plastics using a hot-air furnace.

ASTM International maintains a wide number of test method standards.  They normally provide you with a detailed set of information on the significance and use of a test, how to go about setting up for testing, the proper apparatus and procedures, determining the results, and generating your report.   This is the case with the ASTM D1929.

For those of you who use this Test Method Standard, you’ll be interested in the changes.  Of course, like all updated ASTM standards with technical changes, a redline edition is available.  You’ll get a copy of the clean 2016 Edition plus the previous 2014 Edition with all changes clearly marked.  These changes occur primarily in 3 locations:

  • Clause 6.2.1 has been added.
  • Note 4 has been removed.
  • Note 6 has been added.

One other thing to note:  ASTM D1929 and ISO 871 were harmonized in 1996, so that the technical details of both standards are now the same.

Now you need a copy of this new update and your best choice on where to purchase it is the Document Center Inc. webstore at www.document-center.com.  You can choose paper format or pdf download when you order online.  Or contact our staff for information on enterprise-wide subscription access.  Here is the direct link to the ASTM D1929 order page.  You can reach our staff by phone (650-591-7600) or email (info@document-center.com).

One reason to choose Document Center is our superior notification services.  We routinely alert our customers to changes in their standards collection 1 to 2 months prior to our competitors.  Can you afford to wait 1 or 2 months to learn that your standards are out-of-date?  Do you appreciate having a resource that provides you with information on the changes that have been made, like we do in this blog?  It’s a clear choice — make Document Center your Standards Experts!

The Curious Case of IEC 61000-1-2

IEC 61000-1-2, “Electromagnetic compatibility (EMC) – Part 1-2: General – Methodology for the achievement of functional safety of electrical and electronic systems including equipment with regard to electromagnetic phenomena,” has just been updated.  The new Edition 1.0 is now available from Document Center Inc. in a variety of formats.  It is the formal transformation of the document from the status of a Technical Specification (IEC/TS) to an International Standard.  It cancels the previous Edition 2.0 which is now obsolete.

You may ask yourself, how can an Edition 1.0 replace an Edition 2.0?  This is the first time I can remember seeing this situation occur.  Usually the Technical Specifications have a different numbering schema  (like 2001 Edition or 2nd Edition) to differentiate the TS series from the Standards series should the document make the upgrade in status.

Why is this a status upgrade?  Technical Specifications (like the previous IEC/TS 61000-1-2) are temporary documents with a “life span” of three years.  At that time they can be reviewed to see if it’s appropriate to transform them in to “real” standards or if they should be withdrawn.   Of course, this time frame is not always met.  In the case of the IEC 61000-1-2, the previous Edition 2.0 was released in 2006 and has been current all this time.

What’s the difference between a Technical Specification and a Standard?  One difference is procedural, the other technical.  IEC may choose to release a Technical Specification when the required support for the document is not attained and yet industry needs guidance on the topic.  This has to do with the voting requirements for adoption as an International Standard.  Or IEC may choose to release a document as a Technical Specification when the subject is “under technical development.”  That is, the subject parameters necessary for meeting the requirements of a Standard are not mature enough for consensus.

What are the changes in the new IEC 61000-1-2?  The most important changes are the harmonization with the latest edition of IEC 61508 series, “Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems.”  Also, of course, the document has been completely reviewed to make sure it meets the higher requirements of an International Standard.  And Annex B on measures and techniques for the achievement of functional safety with regard to electromagnetic disturbances has been completely re-written.

Now to get your copy of this new publication.  Choose an authorized distributor like Document Center Inc. for your purchase.  You can search for and order all IEC standards at our webstore, www.document-center.com, with complete confidence that your purchase will be complete, correct, and covered by the laws of copyright.  Here’s the direct link to the order page for IEC 61000-1-2.

Have additional questions or are you interested in our wide array of support services for standards compliance?  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.  Make us your Standards Experts!

 

ISO 5667-24 – Auditing Water Quality Sampling

In honor of Earth Day, we’re going to take a look at the new ISO 5667-24, “Water quality – Sampling – Part 24: Guidance on the auditing of water quality sampling.”  This new standard provides the information you need to verify that a water quality sampling plan is working correctly!  It’s used for water sampling in all kinds of situations — from drinking water to water storage to wastewater and so on.  Failures of water sampling programs can be caused by a variety of reasons.  An audit program like this can help avoid costly and dangerous situations from developing.

What exactly does ISO 5667-24 provide?  The standard includes an “audit protocol to monitor conformity with declared, or assumed, practices in all areas of water quality sampling.”  So you’ll learn how to set up a systematic methodology for assessing practices and procedures used in the field according to your organization’s sampling manual.  This covers all activities from the development of the manual to the delivery of the samples to a testing lab.

What are the special areas covered by the standard?  Of course, the beginning of the standard covers the usual scope, referenced documents and terms and definitions sections.  Next the standard addresses the issues that arise when audits involve more than 1 auditor.  Three sections are devoted to determining auditing objectives — general, internal audits and external audits (third party).

While risk assessment should be part of your audit design, it is not a requirement in this standard.  However, Section 8 provides you with criteria for the indentification of critical factors in your sampling process.  And Section 9 discusses the risk-based approaches as contrasted with judgement-based ones, including auditing assumptions.

Of course a critical component of any process is its documentation, and Section 10 covers how to audit documents involved in the sampling process (like the manual and instruction guides, etc.).  Section 11 covers the real-time audit, again including information on audit forms and field observation.

Now you need to design your audit plan, and that’s covered in Section 12.  Section 13 follows up with how to actually conduct the field assessments and Section 14 reviews the audit methodology.  The final three sections cover completing the audit, creating the audit report and statement of findings, and a review using an outline flow diagram of the audit process itself.  There are 3 informative Annexes as well:  Audit forms, suggested procedures for monitoring your temperature control, and of course, measurement of uncertainty issues.  A 17-item bibliography complete this extensive 106-page publication.

There are extensive rules and regulations regarding water quality.  But without an auditable sampling process to verify that water quality standards are being met, the system is vulnerable to errors and abuse.  The use of the ISO 5667-24 is a good step in the right direction for organizations to tighten up their procedures and processes and to prove that they consistently are meeting regulatory requirements.

If you need a copy of this International Standard, use an authorized distributor like Document Center Inc. for your purchase.  We have been selling standards since 1982 and have had our catalog on the web since 1993 for you to use to search for and order standards.  Go to www.document-center.com for your compliance information needs.  Here is a direct link to the order page for the new ISO 5667-24.  And if you need additional information on the other standards in the ISO 5667 series or on water quality in general, please see our Document Center List of Standards on Water Quality and follow the links to the topics you need.

You may have additional questions or want to start working with Document Center more closely.  We have any number of products and services that can assist you in your compliance efforts.  Just reach out to us by phone (650-591-7600) or email (info@document-center.com).  We’re your Standards Experts!

ASTM C150/C150M 2016 – Portland Cement

ASTM C150/C150M, “Standard Specification for Portland Cement,” has just been revised and the new 2016 Edition is available from Document Center Inc. now in a variety of formats.  Portland cement is the basic ingredient of concrete, mortar, stucco, and most non-speciality grouts.  It is manufactured as a closely controlled chemical combination of calcium, silicon, aluminum, iron and other ingredients.

ASTM C150/C150M covers 10 types of portland cement.  It provides you with sections on such topics as ordering information, ingredients, inspection, packaging, storage and so on.  Annex A1 (required for compliance to the specification) covers the calculation of potential cement phase composition.  The Appendix is non mandatory and focuses on the manufacturer’s certification (otherwise known as a mill test report.)

Changes in the 2016 Edition are found in the following areas, per the statement by the committee that is included at the end of the document:

  • Note A1.2 has been added
  • Revisions have been made to sections 5.1.3 and A1.6.1
  • Revisions have also been made to Table 1 and Figures X1.1 and X1.2

These are changes to a number of formulas, etc., so if you use this specification you’ll want a copy of the new edition.  Of course, you should choose an authorized distributor of the ASTM standards and Document Center Inc. has been one since the 1980’s.

You can search for and order ASTM standards in both paper format and for pdf download at our webstore, www.document-center.com.  Here’s the direct link to the order page for ASTM C150/C150M.  ASTM standards are also available for inclusion in our Standards Online multi-user subscription service.  This is the solution for those of you looking for company wide cloud access to standards.  If you’d like to learn more, just get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We’re your Standards Experts!

ISO 15489-1 2nd Edition – Records Management

ISO 15489-1, “Information and documentation – Records management – Part 1: Concepts and principles,” has just been updated.  This new edition is a technical revision and replaces the previous 1st Edition from September 2001.  You can purchase your copy of the new 2nd Edition from Document Center Inc. in a variety of formats.

Records management is an essential component of a good document control program.  The ISO 15489-1 provides you with a complete overview of the core concepts and principles of the management of records, from creation to archiving.  Since the original release of the standard in 2001, a lot of changes have occurred in this field, primarily due to the increased reliance on digital records.  This has led to a major overhaul of the publication.

After the first 3 sections on Scope, Reference documents, and Terms and definitions, the 1st Edition covered the benfits of records management and the regulatory environment.  No more.  The 2nd Edition moves directly into the Principles of managing records in Section 4 and Records and record systems in Section 5.  Then the Section 6 is the Policies and responsibilities, as before.

Where the old edition reviewed record management requirements in Section 7, the new edition addresses Appraisal, a different take on assessing your needs and the implementation process that will work for you. And following this, the new Section 8 strictly covers Record controls and Section 9 focuses in on the Processes used for creating, capturing and managing records.  This is in contrast to the old publication’s sections on Design and implementation, Processes and controls, Monitoring and auditing, and Training.  And the new 2nd Edition has a 9-item bibliography that was not in the first release.

You may be wondering if this complete re-write of the standard will affect the ISO/TR 15489-2 on Guidelines which is still the 1st Edition from 2001.  There is no committee activity on a new edition for the part 2 at this time.

And of course, you’ll want a copy of this new document if you’re involved in records management or document control at your organization.  Be sure to use an authorized distributor like Document Center Inc. for all your standards purchases to make sure you’re conforming with copyright law.  You can search for and order standards at our webstore, www.document-center.com.  Here’s the direct link to the order page for the ISO 15489-1.

Do you have more questions?  Want to work with a real person in order to place your order?  Contact our staff by phone at 650-591-7600 or by email at info@document-center.com.  We’ve been working with standards since 1982.  Make us your Standards Experts!

EN ISO 15225 2016 is here!

EN ISO 15225, “Medical devices. Quality management. Medical device nomenclature data structure,” has been updated and the 2016  Edition is available from Document Center Inc. in a number of national editions.  This new update adopts the ISO 15225 3rd Edition from 3/2016.  It replaces the previous 2010 Ediiton which is now obsolete.

Because EN ISO 15225 is not part of the harmonized standards list for any of the EU Directives, there are no Annexes and no “transition time.”  However, according to the usual EU protocol, all of the European Union nations must adopt this new revision as a national standard by October 2016.  This means that all identical or conflicting national standards must be withdrawn by October 2016 as well.

Further, should you purchase a copy of this document in English, French or German, the text will be the official text as issued by the EU.  All other language editions are actually translated by the European nation releasing the adoption.  However, those translated editions, if properly notified to CEN and/or CENELEC, do have the same status as the official versions.

Since this is an adoption of an ISO standard, the core content is the ISO standard itself.  This standard defines the Global Medical Device Nomenclature (GMDN).  If you are not familiar with the major changes in the ISO 15225 3rd Edition, here are the highlights:

  • Template terms have been removed as the hierarchy within the GMDN is now managed with the use of ‘collective terms’
  • ‘Device category’ has been removed and replaced by the use of ‘collective terms’
  • The prefix ‘preferred’ has been removed from term in the document and the word ‘term’ now denotes the primary identifier for generic device groups of medical devices
  • ‘Collective terms’ can now be used by medical device regulators and other users to select larger groups of medical devices and analize larger sets of data. ‘Terms’ however remain the only way to identify generic device groups of medical devices
  • ‘Device type’ data specification has been removed as it is outside the scope of the GMDN dataset, but remains a concept to which GMDN data are linked

When it comes to getting a copy of the new European standard, you have a wide range of choices.  Here at Document Center Inc., we provide authorized copies of the BS EN ISO 15225 and of the SS EN ISO 15225.  Of course, you can also search for and order European standards at our webstore, www.document-center.com.  And if you have questions (as many people do), please contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’re your Standards Experts!

 

ISO/TS 19337 – Testing Nano-objects

ISO/TS 19337, “Nanotechnologies – Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicity,” has just been released.  The new technical specification is available now from Document Center Inc.  It is a guide for evaluating possible impacts of “nano-objects” on human health and the environment.

As we become more familiar with the properties and effects of nano materials, we discover that tests for understanding biological effects for them may differ from traditional materials.  After all, many biological tests involve dissolving a chemical in water.  When you do this with many nano-objects, they tend to undergo changes like dissolution into their ionic counterparts or absorbed into the culture medium itself.  Without these properties being understood and accounted for, tests may not give you accurate results.

So the ISO/TS 19337 was developed to describe the essential characteristics and measurement methods of working suspensions containing nano-object samples for in vitro toxicity assays.  It is intended to be used to develop reliable test results for nano-objects to be used by regulators, the general public, manufacturers, and end users.

This technical specification has the usual scope, referenced documents, and definitions sections (including abbreviated terms).  The bulk of the technical material comes in Section 5, Characteristics and measurement methods, and Section 6, Reporting.  The document also provides you with 4 informative annexes – Flow of measurements, measurement and evaluation of stability, measurement of metal ions, and measurement of culture medium components.  A 23-item bibliography completes the publication.

If you’re using nanotechnology in your business, you’ll want a copy of the new specification.  Order your copy at the Document Center Inc. webstore, www.document-center.com.  Here’s a direct link for the order page for ISO/TS 19337.  And if you have additional questions, just get in touch with us by phone at 650-591-7600 or email at info@document-center.com.  We’ve been working with standards since 1982 so make us your Standards Experts!

ISO/IEC 29169 – Conformity Assessment for IT

ISO/IEC 29169, “Information technology – Process assessment – Application of conformity assessment methodology to the assessment to process quality characteristics and organizational maturity,” has just been released.  It’s a milestone in the ISO and IEC’s Joint Committee 1 (JTC 1) effort to promote conformity assessment in the world of IT (information technology).  The standard promotes the mutual recognition of accreditation, tests reports, certifications, and the registration of recognition of a supplier’s declaration of conformity.

The standard has been developed for the IT community.  However,  it is also an outstanding review of conformity assessment and the standards that support it.  That is, while the document focuses on process assessment as defined by ISO/IEC 33001 and ISO/IEC 33002, it uses the core principles of ISO/IEC 17000 and ISO/IEC 17020 which are applicable across industry.

The ISO/IEC 29169 begins with the usual scope, referenced documents and terms and definitions sections.  You’ll then get a thorough (and logical) review of the concepts, functional approach, and general scheme of conformity assessment.  As you move into the later sections, the reliance on the IT specific documentation then becomes clear.  You’ll see this in the details of Section 7 on requirements, Section 8 on planning and performing the assessment, Section 9 for review and attestation, and Section 10 on surveillance.  Section 11 specifically relates the general principles to the specific needs of IT in reviewing the requirements for the operation of the bodies actually performing the inspection.  The concluding 16 item bibliography provides information on closely related ISO/IEC standards and other publications.

For those of you in the IT industry as well as organizations who have an IT component in upir products, the ISO/IEC 29169 will be an invaluable aid to understanding what’s involved in conformity assessment of these types of products.  You’ll need a copy, and you’ll want to make sure that you get it from an authorized distributor like Document Center Inc.

Search for and order standards at our webstore, www.document-center.com.  Here’s a direct link to the order page for ISO/IEC 29169.  You’ll have the option of choosing delivery in paper format or for pdf download.  Want this standard in an enterprise platform for use by your entire organization?  Talk with our staff about our Standards Online cloud solution or the other premium services we offer.  You can reach 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!