New ANSI/AAMI/ISO TIR16775 replaces AAMI TIR22

November 4th, 2014

AAMI has just released their adoption of the ISO/TS 16775 that was released back in May.  This new document is numbered ANSI/AAMI/ISO TIR16775, “Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2.”  It replaces AAMI TIR22, “Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006,” which is now obsolete.

AAMI, the Association for the Advancement of Medical Instrumentation, is the U.S. TAG (Technical Advisory Group) to the ISO committee that developed the ISO/TS 16775.  Since the harmonization of U.S. standards to international standards is a high priority for both business and the standards community, this close working relationship is a boon.  It means that we are able to adopt the ISO standard as written, and to withdraw the TIR22 that previously addressed this topic.

Similarly to the many European adoptions of ISO standards, this publication contains administrative material on the cover sheet and the first 9 introductory pages.  However, beginning with the Foreward on page x, the AAMI adoption is identical to the ISO edition.

Which edition should you use?  Let’s take a look at the pros and cons for each.

1.  From a technical point of view there is no difference between the 2 editions.

2.  The cost of the U.S. adoption is less than that of the ISO original.  This is a benefit for AAMI as the U.S. Tag.  They are able to publish the adoption under their own publication number and set their own price.

3.  The ISO document was released prior to the ANSI/AAMI adoption.  Using a source edition of a standard usually (but not always) means that you’ll be able to purchase new editions sooner.  This is due to the administrative processes of adoption in many cases.

4.  You should always take into consideration any certification requirements when choosing the edition you’ll purchase.  There is nothing as discouraging than to get a valid copy of a standard only to have your auditor reject it because it does not come from the “correct” jurisdiction.

You can get your copy of this Technical Information Report (TIR) from Document Center Inc. via our webstore at www.document-center.com or by contacting our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  It’s available in paper format, for pdf download or as part of your Standards Online multi-user access subscription service.  You’ll find any number of support services available from Document Center Inc. to help make your use and maintenance of these types of conformance documents easier.  Make us your Standards Experts!

 

What’s really scary? Counterfeits!

October 31st, 2014

In the minds of many standardization experts, one of the biggest challenges facing industry is counterfeits.  Of course, there are other scary things in the night — like network security and the safety of the food chain — but for our Halloween haunted house today, we’ll look at counterfeits and the standards that have been developed to combat them.  Here we go!

AS 6081, Fraudulent/Counterfeit Electronic Parts: Avoidance, Detection, Mitigation, and Disposition – Distributors Counterfeit Electronic Parts; Avoidance Protocol, Distributors

Use this standard to manage your supply chain issues.  Developed for the aerospace industry, the uniform requirements, practices and methods of this standard can help you mitigate the risks of purchasing and supplying fraudulent/counterfeit electronic parts.

AS 6174, Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming Materiel

AS 6174 helps you identify, avoid, and report counterfeit or fraudulent materials and parts themselves.

ASTM F1448, Standard Guide for Selection of Security Technology for Protection Against Counterfeiting, Alteration, Diversion, Duplication, Simulation, and Substitution (CADDSS) of Products or Documents

This ASTM standard focuses on the requirements you’ll use to choose a security system to protect your products.  These systems can be used for a wide range of IP applications.

IEC/TS 62668-1, Process management for avionics – Counterfeit prevention – Part 1: Avoiding the use of counterfeit, fraudulent and recycled electronic components

You’ll use this IEC technical specification for defining the requirements necessary for avoiding the use of counterfeits.  It provides requirements for protecting intellectual property (IP).  The committee that developed the publication expects that it will be used not only in avionics, but also other high performance industries, like defense.

IEC/TS 62668-2, Process management for avionics – Counterfeit prevention – Part 2: Managing electronic components from non-franchised sources

This IEC technical specification provides you with the tools you’ll need when you choose to procure components outside the franchised distributor network.  You’ll get an overview of the risks involved, and the process used (derogation) when you’re unable to purchase through the usual channels.  The Annexes provide you with a IEC/TS 62668-1 flowchart, an example of a detailed tests list (linked with procurement risks levels) and iNEMI counterfeit calculator tools.

ISO 12931, Performance criteria for authentication solutions used to combat counterfeiting of material goods

The ISO 12931 covers both goods and their packaging.  It is basic to the whole concept of identifying and eliminating counterfeit goods since it provides you with the criteria for authentication.  It is geared to industry in general, not just avionics.

ISO 16678, Guidelines for interoperable object identification and related authentication systems to deter counterfeiting and illicit trade

One way to avoid counterfeits is to have an authentication system in place.  This ISO standard provides the object information guidelines and other routing requests and responses for such systems.  You’ll also learn how these systems help detect counterfeits.

Standards light the way to solutions for problems that at first can seem insurmountable.  When you’re faced with scary problems like counterfeiting, one good place to start is with standards on the subject.  And what better place to purchase your standards than Document Center Inc.

We’ve been on the Internet since 1993, providing you with a safe, authorized, and secure place to purchase your compliance information.  Use our webstore at www.document-center.com or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Make us your Standards Experts and have a Happy Halloween!

Giants win the World Series – New ASTM Baseball Standards!

October 30th, 2014

Well, here in the San Francisco Bay Area we’re all breathing a little easier now that the Giants have won yet another World Series!  And since I like to bring to your attention the importance of standards in the world around us, this is a great chance to discuss new editions for three ASTM baseball standards!  Of course, in sports team effort and individual achievement rule supreme.  But having equipment and fields that meet requirements for consistency and safety are essential.  Here’s our offering for today:

ASTM F2219, 2014 Edition, Standard Test Methods for Measuring High-Speed Bat Performance

This year’s series was a breathtaking combination of both hitting and pitching.  With both tight games and blowouts, it was a roller coaster ride for both teams.  So bat performance is essential.  When you choose your bat, you want to know various factors like BBCOR (Bat-Ball Coefficient of Restitution – a “trampoline” effect when the bat makes contact with the ball), BESR (Ball Exit Speed Ratio – a ratio of the ball exit speed to the speed of the incoming ball combined with the speed of the bat), and BBS (Batted Ball Speed – the speed with which a bat hits a ball.)  This ASTM standard gives you the details of each of these tests and how to calculate them in laboratory settings.

ASTM F1887, 2014 Edition, Standard Test Method for Measuring the Coefficient of Restitution (COR) of Baseballs and Softballs

COR is the speed of the ball after collision with the bat divided by the speed of the ball before the collision.  In ASTM F1887, you’ve got a procedure that gives you a single, repeatable way to measure this.

ASTM F2845, 2014 Edition, Standard Test Method for Measuring the Dynamic Stiffness (DS) and Cylindrical Coefficient of Restitution (CCOR) of Baseballs and Softballs

In generating your COR, there are some factors to be considered.  One of these is the stiffness of the ball (DS – Dynamic Stiffness), since this can impact the way that the energy transfers between the bat and the ball.  The harder the ball, the more lively it is.  So the procedure is based on ball speed measurements before and after impact, as well as the impact force between the ball and impacted surface.  The other thing that this standard provides is a way to use a cylindrical surface in the test, rather than a flat piece of material.  This gives results that are more like the actual conditions of the sport.

If you’re interested in these types of tests, you’ll want to familiarize yourself with the Sports Sciences Laboratory at Washington State University.  Lloyd Smith, PhD., from that facility is a leading member of the ASTM Committee F08 which develops these standards.

If you need copies of any current (and many obsolete) editions of ASTM standards, please go to the Document Center Inc. website at www.document-center.com.  Here you’ll be able to order the standards you need in paper format or for pdf download.  Want multi-user access?  Ask our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  And as we’ve been know to say around here, “Go Giants!”

New ISO 17516 – Microbiological limits for cosmetics

October 29th, 2014

ISO 17516, “Cosmetics – Microbiology – Microbiological limits,” has just been released.  The new 1st Edition is available now from Document Center Inc. in both paper format and for pdf download.  The document has been adopted by the European Union already and is available as EN ISO 17416 as well.

Cosmetic products are interesting in that they are not expected to be sterile and yet they must be microbiologically safe for users.  So it is incumbent upon manufacturers to insure that these products have been produced under hygienic conditions.  This leaves cosmetic companies with the question:  When and how much should our products be microbiologically tested?

ISO 29621 provides guidance for developing a risk assessment plan to determine what products are vulnerable to microbiological contamination.  And the various testing that may be required can be found in ISO 21148, ISO 21149, ISO 16212, ISO 18415, ISO 18416, ISO 21150, ISO 22717 and ISO 22718.  However, there’s been one element that’s been missing.

Now the new ISO 17516 provides you with acceptable quantitative and qualitative limits for cosmetic finished products.  The document has the usual scope and definitions sections.  Then Clause 3 moves right in the principles guiding the requirements for these types of products.  This includes basic information on limits in general as well as for products intended for use on children, on eye areas and on mucous membranes.

Clause 4 provides you with a table that specifically defines the types of microorganisms that should be tested for and limits based on general use or for the specialized uses noted above.  Annex A completes the document with the presentation of a flowchart for the interpretation of your test results.  And there’s also a 27 item bibliography that you’ll find to be very useful.

Now you need a copy of the new standard.  You’ll choose the ISO or the EN ISO edition based on the jurisdiction of your auditor, if your products or processes are certified.  Then you’ll order on the Document Center Inc. website, www.document-center.com.  Your order options will be available to you there.  Of course, you may prefer to set up multi-user access through our Standards Online subscription service.  In that case, just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

We’ve been providing folks like you with standards and support services since 1982 from our Silicon Valley location.  Make us your Standards Experts!

New IEC 61000-6-7 released – EMC Immunity in Industrial Locations

October 28th, 2014

The IEC 61000 series covers the essential requirements for controlling EMC.  Now the set has been expanded with the addition of IEC 61000-6-7, “Electromagnetic compatibility (EMC) – Part 6-7: Generic standards – Immunity requirements for equipment intended to perform functions in a safety-related system (functional safety) in industrial locations.”  The document was developed to help you when there’s no relevant information on the electromagnetic influences for functional safety.  Because it is used when there’s no specific information on your situation, it’s considered a generic standard.

Who’s going to be using IEC 61000-6-7?  Suppliers should confirm their products meet these requirements when making claims for the immunity of safety-related equipment against electromagnetic disturbances.  And their customers and assessors should also be using it to confirm that such equipment meets these claims as well.

What locations has it been developed for?  It’s for industrial locations that usually have a separate power network dedicated specifically to them.  These might include facilities that do metalworking, car production, working with pulp and paper, or are chemical plants.

What topics are covered by IEC 61000-6-7?  After the usual scope, referenced documents, and definitions sections, the standard provides you with a general overview of the subject.  It discusses conformance to IEC Guide 107 and IEC/TS 61000-1-2.  It covers performance criteria and your test plan. And immunity requirements, test setup and philosophy, and the test results and report are also addressed.  Annex A provides you with a strategy for functions intended for safety applications.  And the standard is completed by the 14-item bibliography.

Since there’s a relationship between electromagnetic disturbances and systematic failures, you’ll want to insure that you’re providing your facility with the best practices available.  So you’ll want to get a copy of this new standard.  Go ahead and order your copy at the Document Center Inc. webstore at www.document-center.com.  Or contact our staff for more information by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

By procuring your standards at Document Center, you’ll know that you’re getting an authorized copies, compliant with copyright laws.  You’ll have flexibility when you order, since IEC standards can be purchased in paper format, for pdf download, and as part of our Standards Online multi-use subscription service.  You’ll have a wide variety of support services available that can assist you in maintaining your standards collection.  And you’ll rest assured that when any of your standards change, you’ll be notified promptly.

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

New ASTM B221 2014 Edition on Aluminum (Extruded)

October 27th, 2014

ASTM B221, “Standard Specification for Aluminum and Aluminum-Alloy Extruded Bars, Rods, Wire, Profiles, and Tubes,” has been updated.  The new 2014 Edition is available from Document Center Inc. in paper format or for pdf download.  It can also be supplied for multi-user access using our Standards Online subscription service.  The specification covers aluminum and aluminum alloy extruded bars, rods, wire, profiles and tubes.  It is one of our best-selling standards on the subject.

ASTM B221′s 41 different alloys are given chemical composition limits in Table 1.  Then Table 2 shows the mechanical property limits of these aluminum alloys and tempers.  It’s a comprehensive document, covering the usual scope, referenced standards and terminology.  You’ll find clauses for ordering information, materials and manufacture, quality assurance, chemical composition, tensile properties, heat treatment and confirmation of same, reheat treatment, various corrosion resistances, cladding, dimensional tolerances, general and internal quality, inspection, retest and rejection, marking and packaging, and certification.

Mandatory Annexes are also provided.  Annex A1 covers the basis for inclusion of property limits.  Annex A2 provides a detailed explanation of the acceptance criteria that an aluminum alloy has to meet in order to be included in this document.  The non-mandatory Appendix X1 finishes up the specification.  It gives you the designations for metals and alloys originally assigned in conformance with ASTM B275.

FYI:  I last reviewed this document when the 2012 Edition was released (ASTM B221 2012 Edition is available).  This is the second change since that last blog.  When the 2012 Edition was updated in 2013, Note 3 was revised.  In this new 2014 Edition, changes have been made to Table 2 to match properties listed in the AS&D (Aluminum Standards and Data.)  And don’t forget:  The metric edition of the document is available as ASTM B221M.

You’ll need a copy of this new edition if you use this specification.  Head to the Document Center Inc. webstore at www.document-center.com.  Here you can order the standards you need from over 500,000 unique titles (about 1,000,000 actual revisions).  If you want additional assistance, just get in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New IEC 62682 – Alarms for the process industry

October 24th, 2014

You’re involved in the process industry and you’ve got equipment that includes alarms that alert the operator to a variety of situations.  Now the new IEC 62682, “Management of alarms systems for the process industries,” is here to provide guidance on systems based on programmable electronic controllers and human-machine interface technology.  You’ll use it for alarms for process control systems, safety instrumented systems, fire and gas systems and emergency response systems.

This is the first edition of the new standard.  It is based, in part, on the ANSI/ISA 18.2 from 2009 (also titled “Management of Alarm Systems for the Process Industries”).  It provides the requirements for both alarm management and alarm systems.  You’ll use it if you manufacture alarms systems, embedded alarm systems, or alarm system software, design or install such systems, operate or maintain them, or audit and assess them.

Clauses 1 to 5 are introductory in nature.  They cover the usual scope, referenced documents, and definitions sections.  Then Clause 4 covers conformance to the standard itself.  Clause 5 provides you with a complete review of alarm system models, including lifecycle, states, response timeline and feedback considerations.

IEC 62682 Clauses 6 to 18 cover the actual requirements themselves.  This is an in-depth discussion of such alarm systems.  It starts with the philosophy issues that guide the choices for the lifecycle stages.  Next there’s coverage of the requirements specification, identification and rationalization, and specific detailed design requirements.  The last Clauses cover implementation, operation, maintenance, monitoring, change management and auditing.  A bibliography finishes off the document.

This is a lengthy and detailed document, with a number of tables giving you a clear view of such things as recommended alarm state indicators and lifecycle stage inputs and outputs.  Since alarm systems are the primary way for operators to know about equipment or process malfunctions, it’s imperative that they be operating correctly and effectively.  The IEC 62682 provides you with the technical details necessary to insure such functioning.

You’ll need a copy and you can purchase it from Document Center Inc. with the assurance that you’re getting an authorized legal copy.  Just go to our webstore at www.document-center.com.  You’ll have the option of ordering it in both paper format or for pdf download.  You can even check in with our staff and set it up as part of a multi-user Standards Online subscription service!  Just get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New ISO 50003 – Auditor requirements for Energy Management Systems

October 23rd, 2014

You’ve decided that you’re going to maximize your usage of energy by setting up an Energy Management System (EnMS).  Now, how do you go about following up to confirm that you’re hitting your goals?  Remember, for quality the mantra is PDCA – Plan, Do, Check, Act.  The ISO 50001, “Energy management systems – Requirements with guidance for use,” has provided you with the basis for both planning and doing.  And the ISO 50002, “Energy audits – Requirements with guidance for use,” has shown you how to check.  But how do you evaluate the folks who’ll be doing the checking?  The new ISO 50003, “Energy management systems – Requirements for bodies providing audit and certification of energy management systems,” provides the answers.

Of course, if your organization does energy audits for others, you’ll need to review this standard to confirm that your staff and processes are in compliance.  But if your organization is going to enter into an agreement with a certification body for auditing, you’ll also want to take a look at this new document.

How would ISO 50003 be helpful to you?  You’ll get an overview of the requirements for the audit planning process, the initial certification audit, the on-site audit, the duration of the audits and multi-site sampling.  You’ll also get a definition of the auditor competence, which will be helpful in setting your own expectations.

Some other helpful features of ISO 50003 are a discussion of the various stages of an EnMS audit in Clause 5.  There’s a table with information on the required EnMS knowledge expectations for the auditor in Clause 6.  Also, Table 2 reviews “technical areas,” a way to classify organizations undergoing auditing to provide a sample of the types of energy uses that are typical for each.  An example would be Heavy Industry, which can include chemical plants, oil refining, semiconductors, ship-building, and so on.

The three Annexes supply additional information (and requirements) for the duration of the EnMS audit, multi-site sampling, and the topic of continual improvement for energy performance.  An eight item bibliography rounds out the publication.

Now you’re interested in EnMS and the auditing process, and you know you need to get the standards in the series.  What’s the next step?  You’ll need to choose an authorized dealer in order to make your purchase.  And for this, you’ll find Document Center Inc. to be your best choice.  We’ve been providing standards from our Silicon Valley location since 1982 and have been on the web since 1993.

Go to the Document Center webstore at www.document-center.com.  You can choose to have ISO standards in paper format or for pdf download.  Prefer multi-user licensing?  Ask our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  And you’ll find we have numerous services that will help you comply with the documentation requirements of any certification system you’ve got in place.  Make us your Standards Experts!

New ASME B31.8 Code for Gas Transmission

October 22nd, 2014

ASME B31.8 covers gas transmission and distribution piping systems, including gas pipelines, gas compressor stations, gas metering and regulation stations, gas mains, and service lines.  Now there’s a new 2014 Edition available from Document Center for this Code, as well as a 2014 update for the companion supplement, ASME 31.8S.

ASME B31.8 is updated on a regular basis.  The last edition was in 2012 (FYI: that revision is now  obsolete and withdrawn).  The Code covers the design, fabrication, installation, inspection, and testing of pipeline facilities used for the transportation of gas. It also covers safety aspects of the operation and maintenance of those facilities.

Titled “Code on Gas Transmission and Distribution Piping Systems,” ASME B31.8 is  applicable up to the outlet of the customer’s meter set assembly. You’ll use it for gas transmission and gathering pipelines, including those that are installed offshore for the purpose of transporting gas from production facilities to onshore locations.  It also covers gas storage equipment of the closed pipe type that is fabricated or forged from pipe or fabricated from pipe and fittings as well as gas storage lines.

The supplement, ASME B31.8S, was written to provide you with the information necessary to develop and implement an effective integrity management program.  Such a program can decrease repair and replacement costs, prevent malfunctions, and minimize system downtime.  Considering the downside to failures of such a system, it makes good sense from personnel and community viewpoints as well as from a business perspective.

Now you need copies of the new updates.  Turn to Document Center for your purchase.  You can order them at our web store at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing standards to industry from our Silicon Valley location since 1982.  Make us your Standards Experts!

ISO/IEC 17788 and ISO/IEC 17789 – Standards for Cloud Computing

October 21st, 2014

You know it had to happen!  Cloud computing is the “hot” technology area and here come the standards!  However, if you’re responsible for developing contracts or fulfilling them, you’re glad of it.  And the new standards I’ll review today cover the basics you need.  ISO/IEC 17788, “Information technology – Cloud computing – Overview and vocabulary,” puts everyone on the same page with regards to concepts and terminology.  ISO/IEC 17789, “Information technology – Cloud computing – Reference architecture,” shows you how the functional layers are structured.  We’ll cover ISO/IEC 17788 and ISO/IEC 17789 separately.

ISO/IEC 17788 (also published as ITU-T-Y.3500) was developed by JTC1′s subcommittee on distributed application platforms and services.  The first half of the document provides you with a list of definitions for 44 terms, as well as other acronyms (FYI: some definitions are taken from other standards).  Then the balance of the standard gives you a review of what cloud computing is, the key characteristics, various roles and activities, and cloud service types.  OK, I thought we’re primarily talking about SaaS (Software as a Service).  But, hey, there’s all sorts of things that can be put on the cloud!  I may be in trouble since Management as a Service is also included (I think that’s my job…)

ISO/IEC 17789 also has been published as an ITU document (ITU-T-Y.3502). There is a brief definitions section followed by Clause 5 on conventions.   Next, cloud computing reference architecture goals and objectives are covered.  Then the standard dives into the heart of the matter, providing you with detailed descriptions and charts to model the user view and the corresponding functional view.  Discussion in Clauses 7 through 10 covers various activities, relationships, and so on.

Annex A delves further into these two views with sections on the relationships between:

  • Customer and service provider
  • Provider and provider (aka “inter-cloud”)
  • Cloud service developer and cloud service provider and
  • Cloud service provider and auditor

A short bibliography of 6 additional standards for further review rounds out this publication.

Now you’ll want to get copies of these two standards.  Head to Document Center’s webstore at www.document-center.com.  Here you can order the standards you need in both paper format and for pdf download.  Want multi-user access?  Ask our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks like you since 1982.  Make Document Center your Standards Experts!