Archive for December, 2011

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Document Center’s Top 20 Best Selling Standards for 2011

Friday, December 30th, 2011

Yes, it’s the end of the year and what better time to highlight our best selling standards of 2011!  Here’s what Document Center customers wanted this year:

  1. ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
  2. ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
  3. AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
  4. 21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299″
  5. BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
  6. ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
  7. IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
  8. AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
  9. ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
  10. ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
  11. ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
  12. ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
  13. ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
  14. SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
  15. ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
  16. ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
  17. BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
  18. ISO 10993-1, 4th Edition with Technical Corrigendum 1 (correction sheet) from 2011, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
  19. ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
  20. ASTM A240, 2011a Edition, “Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications”

These documents are all available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  We’re happy to help you with all your standards questions and requirements.

Happy New Year!

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New ASTM E691 2011 Edition, Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

Thursday, December 29th, 2011

ASTM E691-11, “Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method,” has just been released.  This practice describes the techniques for planning, conducting, analyzing, and treating the results of an interlaboratory study (ILS) of a test method. The statistical techniques described in this practice provide adequate information for formulating the precision statement of a test method.

ASTM E691 does not concern itself with the development of test methods but rather with gathering the information needed for a test method precision statement after the development stage has been successfully completed. The data obtained in the interlaboratory study may indicate, however, that further effort is needed to improve the test method.

Since the primary purpose of this practice is the development of the information needed for a precision statement, the experimental design in this practice may not be optimum for evaluating materials, apparatus, or individual laboratories.

This practice is concerned exclusively with test methods which yield a single numerical figure as the test result, although the single figure may be the outcome of a calculation from a set of measurements.

ASTM regulations require precision statements in all test methods in terms of repeatability and reproducibility. This practice may be used in obtaining the needed information as simply as possible. This information may then be used to prepare a precision statement in accordance with ASTM E177, “Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods.”

All current ASTM standards, and many obsolete ones, are available from Document Center Inc. at our website, www.document-center.com.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our staff is available from 6 am to 5 pm Monday through Friday California time.

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New ISO/IEC TR 11581-1 released on Information technology – User interface icons

Wednesday, December 28th, 2011

ISO/IEC TR 11581-1:2011, “Information technology — User interface icons — Part 1: Introduction to and overview of icon standards,” has just been released.  The technical report introduces the ISO/IEC 11581 series and provides developers and other icon standards users with an overview of currently available and future anticipated icon standards.

Icons are used on Information and Communications Technology (ICT) products to facilitate interaction with their users.  They are especially suitable for elements that are frequently used and where the meaning of the icon can be easily understood.  They are usually graphical, but can also be auditory or tactile as well.

The previous edition, ISO/IEC 11581-1:2000, is being merged into the new edition of ISO/IEC 11581-10.  In the meantime, it is still current.

ISO/IEC TR 11581-1:2011:

  • describes the structure of parts that will be used to encompass all present and future icon standards;
  • introduces currently existing icon standards, whether they are parts of ISO/IEC 11581 or they have their own separate numbers

The technical report will continue to change as new parts of the series become available, adding to or replacing the current set of parts.

The series provides several parts, each presenting icons on specific types of icons (object icons, pointer icons, action icons, etc.).  Part 41, currently in development, will define the data structure to be used by the ISO/IEC JTC 1/SC 35 icon database (JTC is Joint Technical Committee and SC is Sub Committee).

Here’s the complete list of the series as published as of today:

ISO/IEC TR 11581-1:2011, Information technology — User interface icons — Part 1: Introduction to and overview of icon standards

ISO/IEC 11581-1:2000, Information technology — User system interfaces and symbols — Icon symbols and functions — Part 1: Icons — General

ISO/IEC 11581-2:2000, Information technology — User system interfaces and symbols — Icon symbols and functions — Part 2: Object icons

ISO/IEC 11581-3:2000, Information technology — User system interfaces and symbols — Icon symbols and functions — Part 3: Pointer icons

ISO/IEC 11581-5:2004, Information technology — User system interfaces and symbols — Icon symbols and functions — Part 5: Tool icons

ISO/IEC 11581-6:1999, Information technology — User system interfaces and symbols — Icon symbols and functions — Part 6: Action icons

ISO/IEC 11581-10:2010, Information technology — User interface icons — Part 10: Framework and general guidance

ISO/IEC 11581-40:2011, Information technology — User interface icons — Part 40: Management of icon registration

All current (and many obsolete) editions of both ISO and IEC are available from Document Center Inc. through our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with all your standards questions and requirements.

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New Change Notice issued for UL-94 5th Edition, Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances

Tuesday, December 27th, 2011

UL 94, “Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances,” has just been modified by the 12/7/2011 revision.  Changes are noted in the margins of the 20-page document.  It amounts to a change notice for the 1996 standard, one of 14 that have been released since the original publication of the document.

These revisions to ANSI/UL 94 are being issued to address the following changes in requirements:

Clarification of the VTM Test Procedure

Harmonization of Conditioning Time and Temperature

Harmonization of Gas Supply

Editorial Revisions

Additionally, three paragraphs, 8.1.2, 8.3.2, and 11.1.1, will become effective as of October 23, 2012.

The UL 94 covers tests for flammability of plastic materials used for parts in devices and appliances.  The tests are intended to serve as a preliminary indication of their acceptability with respect to flammability for a particular application.

The methods described in the document involve standard size specimens and are intended to be used solely to measure and describe the flammability properties of materials, used in devices and appliances, in response to heat and flame under controlled laboratory conditions. The actual response to heat and flame of materials depends upon the size and form, and also on the end-use of the product using the material.

The standard also allows for assessment of other important characteristics in the end-use application including factors such as ease of ignition, burning rate, flame spread, fuel contribution, intensity of burning, and products of combustion.

The final acceptance of the material is dependent upon its use in complete equipment that conforms with the standards applicable to such equipment. The flammability classification required of a material is dependent upon the equipment or device involved and the particular use of the material. The performance level of a material determined by these methods shall not be assumed to correlate with its performance in end-use application.

If found to be appropriate, the requirements can be applied to other nonmetallic materials.  However, these requirements do not cover plastics when used as materials for building construction or finishing.

A product that contains features, characteristics, components, materials, or systems new or different from those covered by the requirements in UL 94, and that involves a risk of fire or of electric shock or injury to persons shall be evaluated using appropriate additional component and end-product requirements to maintain the level of safety as originally anticipated by the intent of the standard.

All current UL standards are sold under license with UL at the Document Center Inc. website, www.document-center.com.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  As other standards resources move to solely rely on the use of websites, Document Center provides complete customer service and support with staff available to answer your questions during our business hours, 6 am to 5 pm Monday through Friday, California time.

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New Italian Standard on Guidelines for festivities celebration spreads Holiday Cheer

Friday, December 23rd, 2011

In the face of economic uncertainty and questions about the fate of European solidarity, the Italians have released Standard CEI 25.12.2011, “Guidelines for festivities celebration,” to give us a smile and spread a little holiday cheer!

Created to mimic the usual format of legitimate standards, the Guideline has all the usual sections.  For example, here is a translation of the scope paragraph:

In mid-2002, the Ministry of Attention (MDA) and the Ministry of
Tradition and Folklore (MDTF) expressed a desire for standardization of the rituals that accompany the event which has taken place on December 25th for many centuries now.  Although over time there has been a lot of literature on the subject, the ministries concerned have felt the need to publish a standard for a safe and quality-focused celebration.  This document was  thus developed in the context of the recent Directive on Standards and Values ​​and in the light of the disappearance of the same standards and values, as well as to promote the nature of the tradition of the historical and educational Santa Claus.

Please be sure to look at the entire standard, as it contains many cogent points and supportive illustrations.  And use Google translate to help you out as well!  The text has been very well thought out.

Our hats off to the committee that has brought us such a timely and valuable document!

There are actually few spoof standards available for review.  The only other one I’ve ever come across is ASA K100.1, “American National Standard Safety Code and Requirements for Dry Martinis.”   The ASA Sectional Committee on Liquids Management, 16-1, hoped the standard would be well received by all elements of the industry and that when the committee sobered up it would be in condition to consider further developments in the state of the art.  I’m unsure of the outcome, as the standard was generated in 1966 and has remained stable ever since!

These standards lend a bit of fun and lightness to an area of business that is often very competitive and serious, proving that engineers have a sense of humor too.

Buon Natale!  And best wishes for the New Year from us all at Document Center Inc.!

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New IPC-2223 Revision C, Sectional Design Standard for Flexible Printed Boards

Thursday, December 22nd, 2011

IPC-2223C, “Sectional Design Standard for Flexible Printed Boards,” has just been released.  It provides design information for different flexible and rigid-flex printed board types.  The 39 page standard is  intended to establish specific design details that are to be used in conjunction with IPC-2221, “Generic Standard on Printed Board Design.”  It may also be used in conjunction with IPC-2222, “Sectional Design Standard for Rigid Organic Printed Boards,” for the rigid sections of rigid-flex circuits.

The standard establishes the specific requirements for the design of flexible printed circuit applications and its forms of component mounting and interconnecting structures. The flexible materials used in the structures are comprised of insulating films, reinforced and/or non-reinforced, dielectric in combination with metallic materials.

These interconnecting boards may contain single, double, multilayer, or multiple conductive layers and can be comprised wholly of flex or a combination of both flex and rigid.

IPC 2223 Revision C provides new design guidance and requirements for bends, folds and creases, staggered flexible layer bands, and strain relief fillets. Also included is a new design tutorial providing guidance on material selection, size and shape of flexible circuits and fabrication allowances.

All IPC standards can be purchased from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re known for our responsive and expert customer service and can help you with all your standards needs.

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New ASTM D1003 2011(e1) Edition has Editorial Changes for Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics

Wednesday, December 21st, 2011

ASTM D1003:2011(e1) Edition, “Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics,” has just been released.  The new revision contains editorial changes only and does not impact the technical content of the 2011 Edition.

This test method covers the evaluation of specific light-transmitting and wide-angle-light-scattering properties of planar sections of materials such as essentially transparent plastic. Two procedures are provided for the measurement of luminous transmittance and haze. Procedure A uses a hazemeter (described in Section 5) and Procedure B uses a spectrophotometer (Section 8). Material having a haze value greater than 30 % is considered diffusing and should be tested using Practice ASTM E2387, “Standard Practice for Goniometric Optical Scatter Measurements.”

The concept of the (e1) Editions is confusing at first, but when explained is easy to understand.  It is an unusual designation but used with some regularity by ASTM International.  It means that the standard has been modified in a way that does not affect the technical content of the document.

So in the case of ASTM D1003, the new 2011(e1) edition re-formats the 2011 edition by consolidating the 4 tables onto one page instead of two.  This re-positioning of the tables makes them easier to find and use, but does not affect the standard itself.

Editorial changes can be changes to addresses or phone numbers referenced in the footnotes, or other similar small corrections to non-technical matters.  So the big question is, when an editorial correction is released, should you purchase it or not?

We suggest the following to our customers.  If you are regularly audited and need to have your documentation confirmed current, you should purchase the corrected edition.  It’s just not worth the cost of the corrected edition to risk being written up during an audit.  If you are interested in using the document for the sake of the content only, it is probably OK to wait for the next revision level.  And the same advice holds true for reaffirmed editions as well.

All ASTM current standards and many of the obsolete revisions are available from Document Center Inc. via our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with all your standards questions and requirements.

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New SAE J200 2011 Edition on Classification System for Rubber Materials

Tuesday, December 20th, 2011

SAE J200 2011 Edition, “Classification System for Rubber Materials,” has just been released.  This classification system tabulates the properties of vulcanized rubber materials (natural rubber, reclaimed rubber, synthetic rubbers, alone or in combination) that are intended for, but not limited to, use in rubber products for automotive applications.  This new revision replaces the previous 2008 Edition, which is now obsolete.

Ground Vehicle Standard SAE J200 is the under the jurisdiction of SAE Committee on Automotive Rubber Specifications (CARS).  CARS Works closely with and receives input from ASTM Subcommittee D11.30 on Classification of Rubber Compounds with the goal to keep SAE J200 and ASTM D2000 (“Standard Classification System for Rubber Products in Automotive Applications”) technically equivalent.

This document may serve many of the needs of other industries in much the same manner as SAE numbered steels. It must be remembered, however, that this system is subject to revision when required by automotive needs. It is recommended that the latest revision always be used.

This document is based on the premise that all rubber materials intended for use in rubber products can be arranged into characteristic designations. These designations are determined by types, based on resistance to heat aging, and classes, based on resistance to swelling by oil. Basic levels are thus established which, together with values describing additional requirements, permit complete description of the quality of all rubber materials.  In all cases where provisions of this document would conflict with those of the detailed specifications for a particular product, the latter shall take precedence.

When the rubber product is to be used for purposes where the requirements are too specific to be completely prescribed by this classification system, it is necessary for the purchaser to consult the supplier in advance to establish the appropriate properties, test methods, and specification test limits.

SAE J200 2011 Edition and all SAE Standards and other documents, both current and obsolete, are available from Document Center Inc.  You can use the Document Center website, www.document-center.com, or phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) us to place your order or to get additional information on any standard you may need.

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New ISO 26262 Series released on Road vehicles — Functional safety

Monday, December 19th, 2011

The new ISO 26262 series has just been issued.  It’s been on our watch list for most of 2011!   ISO 26262 addresses possible hazards caused by malfunctioning behavior of electrical and/or electronic (E/E) safety-related systems, including interaction of these systems.  These types of hazards have been the basis of a number of vehicle recalls here in the U.S., so the release of this standards set is timely.

The series does not address hazards related to electric shock, fire, smoke, heat, radiation, toxicity, flammability, reactivity, corrosion, release of energy and similar hazards, unless directly caused by malfunctioning behaviour of E/E safety-related systems.

ISO 26262 is intended to be applied to safety-related systems that include one or more electrical and/or electronic systems and that are installed in series production passenger cars with a maximum gross vehicle mass up to 3 500 kg.  ISO 26262 does not address unique E/E systems in special purpose vehicles such as vehicles designed for drivers with disabilities.

Systems and their components released for production, or systems and their components already under development prior to the publication date of ISO 26262, are exempted from the scope.  For further development or alterations based on systems and their components released for production prior to the publication of ISO 26262, only the modifications will be developed in accordance with ISO 26262.

ISO 26262 does not address the nominal performance of E/E systems, even if dedicated functional performance standards exist for these systems (e.g. active and passive safety systems, brake systems, Adaptive Cruise Control).

ISO 26262-1:2011, “Road vehicles — Functional safety — Part 1: Vocabulary,”  specifies the terms, definitions and abbreviated terms for application in all parts of ISO 26262.

ISO 26262-2:2011, “Road vehicles — Functional safety — Part 2: Management of functional safety,” specifies the requirements for functional safety management for automotive applications, including the following:

  • project-independent requirements with regard to the organizations involved (overall safety management), and
  • project-specific requirements with regard to the management activities in the safety lifecycle (i.e. management during the concept phase and product development, and after the release for production).

ISO 26262-3:2011, “Road vehicles — Functional safety — Part 3: Concept phase,” specifies the requirements for the concept phase for automotive applications, including the following:

  • item definition,
  • initiation of the safety lifecycle,
  • hazard analysis and risk assessment, and
  • functional safety concept.

ISO 26262-4:2011, “Road vehicles — Functional safety — Part 4: Product development at the system level”  specifies the requirements for product development at the system level for automotive applications, including the following:

  • requirements for the initiation of product development at the system level,
  • specification of the technical safety requirements,
  • the technical safety concept,
  • system design,
  • item integration and testing,
  • safety validation,
  • functional safety assessment, and
  • product release.

ISO 26262-5:2011, “Road vehicles — Functional safety — Part 5: Product development at the hardware level,” specifies the requirements for product development at the hardware level for automotive applications, including the following:

  • requirements for the initiation of product development at the hardware level,
  • specification of the hardware safety requirements,
  • hardware design,
  • hardware architectural metrics, and
  • evaluation of violation of the safety goal due to random hardware failures and hardware integration and testing.

The requirements of ISO 26262-5:2011 for hardware elements are applicable both to non-programmable and programmable elements, such as ASIC, FPGA and PLD. Furthermore, for programmable electronic elements, requirements in ISO 26262-6, ISO 26262-8:2011, Clause 11, and ISO 26262-8:2011, Clause 12, are applicable.

ISO 26262-6:2011, “Road vehicles — Functional safety — Part 6: Product development at the software level,” specifies the requirements for product development at the software level for automotive applications, including the following:

  • requirements for initiation of product development at the software level,
  • specification of the software safety requirements,
  • software architectural design,
  • software unit design and implementation,
  • software unit testing,
  • software integration and testing, and
  • verification of software safety requirements.

ISO 26262-7:2011, “Road vehicles — Functional safety — Part 7: Production and operation,” specifies the requirements for production, operation, service and decommissioning.

ISO 26262-8:2011, “Road vehicles — Functional safety — Part 8: Supporting processes,” specifies the requirements for supporting processes, including the following:

  • interfaces within distributed developments,
  • overall management of safety requirements,
  • configuration management,
  • change management,
  • verification,
  • documentation,
  • confidence in the use of software tools,
  • qualification of software components,
  • qualification of hardware components, and
  • proven in use argument.

ISO 26262-9:2011, “Road vehicles — Functional safety — Part 9: Automotive Safety Integrity Level (ASIL)-oriented and safety-oriented analyses,” specifies the requirements for Automotive Safety Integrity Level (ASIL)-oriented and safety-oriented analyses, including the following:

  • requirements decomposition with respect to ASIL tailoring,
  • criteria for coexistence of elements,
  • analysis of dependent failures, and
  • safety analyses.

An additional part 10, ISO-26262-10:2011, “Road vehicles — Functional safety — Part 10: Guideline on ISO 26262,” is expected to be released shortly.

All current ISO standards, and many obsolete editions, may be purchased from Document Center Inc. using our website, www.document-center.com.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

I was reminded over the weekend how much people appreciate the fact that our staff is available to immediately answer your phone calls, faxes and emails during our business hours of 6 am to 5 pm Monday through Friday California time.  Knowing our phone is answered by a person, not a phone tree, and that Document Center responds to questions in a matter of minutes instead of a matter of days is really appreciated by our customers.

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Whatever happened to QQ-P-35, Passivation Treatments for Corrosion Resistant Steel?

Friday, December 16th, 2011

QQ-P-35, “Passivation Treatments for Corrosion Resistant Steel,” is another government document that was cancelled due to the implementation of the National Technology Transfer and Advancement Act in the mid-1990′s.  The public law, known as NTTAA, directs Federal Agencies to use technical standards “that are developed or adopted by voluntary consensus standards bodies.”  Since QQ-P-35 was a Federal Specification it was an obvious candidate for replacement with a U.S. industry standard.

QQ-P-35 was originally issued in July 1963.  Revision C from 1988 was withdrawn by Cancellation Notice 3 on 9/11/1998.  The Cancellation Notice specifies that QQ-P-35 can be replaced by both ASTM A967 and AMS QQ-P-35.  This shows the use of two types of replacement documents:  1) a pre-existing standard (ASTM A967) and 2) a standard that is a republication of the withdrawn government to migrate the caretaking of the standard from a government organization to an industry one (AMS QQ-P-35).

The other interesting point about this particular superseding history is that seven years after the AMS republication of the specification, the document (AMS QQ-P-35) was itself cancelled in favor of another AMS standard, AMS 2700.  This actually was possible because of government participation in the committee that writes the AMS 2700 standard.  With the publication of Revision B in February 2004, issues in the previous edition of the document that made it unsuitable for government usage were resolved.  Thus the final migration to an industry standard was made possible.

So now, the current replacements for QQ-P-35 are the ASTM A967, “Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts,” and AMS 2700, “Passivation of Corrosion Resistant Steels.”

In actuality, the number of government documents that were republished in this way in order to facilitate migration to industry-sponsored standards is relatively small.  It was certainly made possible because the federal level government documentation is not covered by copyright.  And by this time, many of those republications have been revised or withdrawn as well.

Should you have an obsolete document and need to know what it was replaced by, contact Document Center staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been keeping records on standards since 1982 and for many items, our history information goes back much further.

All current Federal Specifications can be purchased at our website, www.document-center.com.  Many obsolete revisions are available, along with the documents that have replaced them.

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