Popular ASTM Standards on Consumer, Pharmaceutical and Medical Packaging

ASTM International produces standards on a wide range of topics.  With a history of specializing in testing and material standards, the organization issues short, concise, and focused documents used the world over.  They are among the most frequently ordered standards we sell.  In today’s blog, we’ll list those ASTM standards for consumer, pharmaceutical and medical Packaging.

  • ASTM D2063 / D2063M, Standard Test Methods for Measurement of Torque Retention for Packages with Continuous Thread Closures Using Non-Automated (Manual) Torque Testing Equipment
  • ASTM D3198, Standard Test Method for Application and Removal Torque of Threaded or Lug-Style Closures
  • ASTM D3469, Standard Test Methods for Measurement of Vertical Downward Forces to Disengage Type IIA Lug-Style Child-Resistant Closures
  • ASTM D3470, Standard Test Method for Measurement of Removal Lug Strippage of Type IIA Child-Resistant Closures
  • ASTM D3472, Standard Test Method for Reverse-Ratchet Torque of Type IA Child-Resistant Closures
  • ASTM D3474, Standard Practice for Calibration and Use of Torque Meters Used in Packaging Applications
  • ASTM D3475, Standard Classification of Child-Resistant Packages
  • ASTM D3481, Standard Test Method for Manual Shelling Two-Piece Child-Resistant Closures That Are Activated by Two Simultaneous Dissimilar Motions
  • ASTM D3810, Standard Test Method for Minimum Application Torque of Type IA Child-Resistant Closures
  • ASTM D3968, Standard Test Method for Monitoring of Rotational Torque of Type IIIA Child-Resistant Closure
  • ASTM D4267, Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
  • ASTM D4774, Standard Specification for User Applied Drug Labels in Anesthesiology
  • ASTM D4775, Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
  • ASTM D5022, Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use
  • ASTM D5094 / D5094M, Standard Test Methods for Gross Leakage of Liquids from Containers with Threaded or Lug-Style Closure
  • ASTM D6398, Standard Practice to Enhance Identification of Drug Names on Labels
  • ASTM D7257, Standard Test Method for Automated Shelling Two-Piece Child-Resistant Closures That Are Activated by Two Simultaneous Dissimilar Motions
  • ASTM D7298, Standard Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
  • ASTM D7709, Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

Document Center Inc. has been an authorized reseller of ASTM standards since the 1980’s.  Use our website, www.document-center.com, to order online or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have an extensive collection of obsolete standards, as well as all current editions.

What ever happened to MIL-Q-9858?

One of our all-time best selling military specifications was MIL-Q-9858, “Quality Program Requirements.”  From 1958 to 1996, the document was a staple of the defense contracting system.  It provided guidance for a quality management system for thousands of companies, large and small, involved in defense work both as a prime contractors and subcontractors.

What happened to MIL-Q-9858?  The document was cancelled with the issuance of cancellation notice 2 on 10/1/1996 and left many companies in a quandary over what to do, since it was withdrawn without replacement.   This means that there is no guidance given regarding what document can be used instead.

In the main, the move has been to use the ISO 9000 series of quality standards in lieu of the old MIL-Q-9858.  ISO 9001 was adopted by the DoD in April 2001, as was the AS9100 in 2002 (for aerospace applications).  This resulted in a sharp uptick in ISO 9000 registrations in the U.S.

What’s the main impact of the cancellation of MIL-Q-9858?  This shift to industry quality standards has allowed the U.S. Department of Defense to move out of the business of certifying quality in it’s supply chain, leaving this work to third party auditors.

Military specifications and standards (both current and obsolete) and industry standards are all available from Document Center Inc.   Use 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.

ISO 15223 Series on Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

ISO 15223 has been around since 1998, but in 2007 it was split into 2 parts covering two distinct topics.  We often sell this set here at Document Center Inc. so I thought you might appreciate a brief synopsis of the two documents.

ISO 15223-1:2007 is titled “Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.”  Note the English spelling for labeling.  All ISO standards are published using the English spelling, not the American.  The standard is not complete without Amendment 1, ISO 15223-1:2007/Amd 1:2008.  So be sure to order both items when you purchase the standard.

ISO 15223-1:2007 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy it’s requirements.

ISO 15223-1:2007 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.

ISO 15223-2:2010, titled “Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation,” specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

These standards, and all ISO and IEC documents, are 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).  We’re happy to answer any questions you may have about these publications.

Document Center’s Top 20 Best Selling Standards for 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!

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

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.

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

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.

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

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.

New Italian Standard on Guidelines for festivities celebration spreads Holiday Cheer

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.!

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

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.

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

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.