New ISO 13408-1 and ISO 13408-6 Amendments released for Aseptic Processing for Health Care Products

The ISO 13408 series covers sterilization of health care products, including medical devices, that cannot be terminally sterilized (sterilization in the final sealed container).  For these types of products the use of aseptic handling, filling, transfer and packaging may be required to insure the safe delivery of a product to a customer.

Two amendments have been released for standards in the series:  Amendment 1 for ISO 13408-1 2008 (2nd) Edition, “Aseptic Processing of Health Care Products – Part 1: General Requirements,” and Amendment 1 for ISO 13408-6 2005 (1st) Edition, “Aseptic Processing of Health Care Products – Part 6: Isolator Systems.”  If you use either of these standards, it is critical that you get the new amendments right away.  They are sold separately from the standards and they’re available now from Document Center Inc.

Amendment 1 for ISO 13408-1 contains 5 pages of corrections, termed “pen and ink” changes.  These are minor but extensive changes to the standard that need to be met by the user.  Most can be inserted into your copy of the 2nd edition by hand, however one of the tables (Figure A.1) will need to be replaced in it’s entirety.

Amendment 1 for ISO 13408-6 contains 4 pages of similar corrections.  It makes changes to the foreword and to pages 1, 2, 3, 4, 6, 8, 9, 10, 11, 13, 14, 15 and 17.  Get out your pen!

Here’s a list of all the standards that make up the ISO 13408 series:

  • ISO 13408-1:2008, Aseptic processing of health care products — Part 1: General requirements
  • ISO 13408-2:2003, Aseptic processing of health care products — Part 2: Filtration
  • ISO 13408-3:2006, Aseptic processing of health care products — Part 3: Lyophilization
  • ISO 13408-4:2005, Aseptic processing of health care products — Part 4: Clean-in-place technologies
  • ISO 13408-5:2006, Aseptic processing of health care products — Part 5: Sterilization in place
  • ISO 13408-6:2005, Aseptic processing of health care products — Part 6: Isolator systems
  • ISO 13408-7:2012, Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products

You can purchase all current and many obsolete ISO standards from your authorized dealer, Document Center Inc., at our web store: 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 provide you with the services you need to keep your standards collection complete and correct!  We’re your Standards Experts.

New ANSI/ASSE A10.9 2013 on Safety Requirements for Masonry and Concrete Work

ANSI/ASSE A10.9 2013 Edition, “Safety Requirements for Masonry and Concrete Work,” has just been released.  The document is one of the American National Standards for Construction and Demolition Operations.  It’s used by construction companies to meet OSHA standards.

The ANSI/ASSE A10.9 establishes safety requirements pertaining to concrete construction and masonry work in construction. The requirements cover all on-site concrete construction and masonry work including design, erection, operation and maintenance of aggregate processing plants, concrete mixing plants and conveyances.

It also contains safety requirements regarding the specialty concrete operations of prestressing by pretensioning or post-tensioning, lift-slab construction, tilt-up construction and slipforms.

The new 48-page ANSI A10.9 2013 Edition was released to update the information relating to reinforcing steel and post-tension operations.  It is intended to help industry meet new Occupational Safety and Health Administration (OSHA) standards.

ASSE, the American Society of Safety Engineers, has put in a request to OSHA to have the references in  title 29 CFR Part 1926 (Safety and Health Regulations for Construction) updated to include this new edition of the standard, which replaces all previous editions.

All ASSE standards are available from Document Center’s web store, www.document-center.com.  They are sold in both paper and pdf format under license agreement with ASSE.  Should you prefer, you are welcome to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts and we’re here to assist you with all your compliance documentation requirements.

New SAE J429, Mechanical and Material Requirements for Externally Threaded Fasteners

SAE has released a new 2013 edition of SAE J429, “Mechanical and Material Requirements for Externally Threaded Fasteners,” and you can purchase it now from Document Center Inc. in both paper and pdf format.  The Ground Vehicle Standard covers the mechanical and material requirements for inch-series steel bolts, screws, studs, screws for sems (screw and washer assemblies), and U-bolts in sizes to 1-1/2 in. inclusive.

FYI: The U-bolts in SAE J429 2013 are used predominantly in the suspension and related areas of vehicles.  They are treated like studs in this document.  SAE recommends that designers using this standard review the actual load-carrying capacity of them with saddle load tests.

The studs in this standard are cylindrical rods of moderate length, threaded on either one or both ends, or even throughout the entire length of the stud.  Any products that use a head, collar, or something similar are referred to as bolts.  Table 2 covers the chemical composition requirements.

The 2013 Edition is a revision of the previous J429 released in September of 2009.  The new edition replaces all previous editions, which are now obsolete.

SAE standards and specifications can all be purchased at Document Center’s web store, www.document-center.com.  Or you can reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We sell the documents under license agreement with SAE and can provide you with on-going support with notification and reporting services.

For more information on new releases, please check in with Document Center’s new blog, blog.document-center.com.  It is a welcome addition to the informational services provided by our company.

 

New EIA 748 Revision C released for Earned Value Management Systems

TechAmerica has just released the new EIA 748C, “Earned Value Management Systems.”  The standard describes the Earned Value Management System (EVMS), a tool for scheduling budget and tracking expenses.  The new 36-page Revision C is the first update since Revision B in June of 2007.

Processes included in EIA 748 are:

  • the integration of program scope, schedule, and cost objectives,
  • the establishment of a baseline plan for accomplishment of program objectives, and
  • the use of earned value techniques for performance measurement during the execution of a program.

These processes allow for the establishment and application of an integrated program management system that brings together the elements of the work scope, scheduling, and cost objectives.  The method is a system of “earned value” established during the planning phase and tracked during the execution (control) phase of a project.

EIA was an umbrella organization for a number of electronic industry associations that ceased to exist in 2011.  TechAmerica is now responsible for the EIA standards that were generated by GEIA, the Government Electronics and Information Technology Association.  All of this series of the EIA standard are available from Document Center’s Webstore, www.document-center.com, in both paper and pdf format.

Should you have any further questions, please contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts and we’re here to help you use your standards to your best advantage!

New ISO 3534-3 released for Statistics – Design of experiments

There a new ISO 3534-3 3rd Edition, “Statistics – Vocabulary and symbols – Part 3: Design of experiments,” that has just been released.  The new revision defines statistical terms and symbols used for the design of experiments.  It is 106 pages in length because the text is in both English and French.

Experiments that use the statistical analysis terms of this standard will have a one-dimensional and continuous response variable.  This standard on statistics also assumes that the error term follows a normal distribution with constant variance.

Definitions contain a wealth of information provided as equations, tables and figures.  Annex A covers Concept Diagrams, with an explanation provided in Annex B.  Checklists for designed experiments can be found in Annex C.  And a description of experimental design from the systems model perspective in presented in Annex D.

There are a total of 3 parts in the ISO 3534 series:

  • ISO 3534-1:2006, Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
  • ISO 3534-2:2006, Statistics — Vocabulary and symbols — Part 2: Applied statistics
  • ISO 3534-3:2013, Statistics — Vocabulary and symbols — Part 3: Design of experiments

An additional Part, ISO 3534-4, Statistics — Vocabulary and symbols — Part 4: Survey sampling, is at the draft stage.  The release date has not yet been determined.

ISO standards can be purchased at Document Center’s web store, www.document-center.com.  Territorial restrictions may apply.  If you like, you can always reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts and we’re here to assist you with all your compliance information requirements.

New Amendment 1 issued for ISO 178 on Flexural Properties of Plastics

ISO 178 5th Edition, “Plastics – Determination of Flexural Properties,” has just been updated with the release of Amendment 1.  It makes changes to ISO 178 and you’ll need to get a copy it order to be in compliance.

You’ll use ISO 178:2010 to test flexural strength, flexural modulus, and other aspects of the flexural stress/strain relationship in order to confirm that the material is appropriate for your application.  It uses a freely supported beam, loaded at mid span (three-point loading test).

The amendment for this standard is purchased separately.  It contains changes to the following sections of the standard:

  • Page iv, Foreword
  • Page 7, 5.5.1
  • Page 11, 8.1 (replaces figure 5)
  • Pages 10 to 11, 8.1
  • Page 11, 8.2
  • Page 15, 11 d)

As you can see, the changes are extensive, resulting in an 8-page amendment.

Remember, your copy of ISO 178 5th Edition is obsolete without this new amendment.  You can purchase it and all ISO standards at the Document Center web store, www.document-center.com.  Territorial restrictions may apply.  If you prefer, you can always 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 and we’re here to help you.

What does “Noncurrent” mean for AMS Standards?

Here at Document Center, we often are asked very specific questions about standards.  Just yesterday, a client asked me about the AMS 2405.  He wanted to know what “Noncurrent” meant in the title.

“Do you remember the use of the phrase ‘Inactive for New Design’ in Mil Specs and Standards?” I queried.  And of course, because this customer has been doing business with us since the 1980’s, he certainly did.  “Noncurrent is the SAE equivalent status.”

However there are some subtle differences in the two terms.  A noncurrent standard is not recommended for new design, but still can be used.  A document that is inactive for new design cannot be used for new design.

So the AMS 2405 has not been recommended for new design since 2000, when SAE released the notice of noncurrent status  as AMS 2405 Revision C.  We looked to see if SAE had suggested another standard for new design, but no.   Our closest match was the AMS 2404.

It is not uncommon for standards users not to fully understand the administrative terminology that is used to describe the document by the issuing agency.  If you ever have any questions about the status of a particular document, please get in touch with us.  There are many situations where this type of confusion can negatively impact your business.

You can always use the Document Center webstore at www.document-center.com to place your orders and look up information on the standards you need.  But you can also contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) with any questions you may have.

New Amendment released for ISO 9660 on CD Roms

ISO 9660, “Information Processing – Volume and File Structure of CD-Rom for Information Interchange,” has just been modified by the release of a new Amendment 1. The new update is available from Document Center now.  ISO 9660 specifies the volume and file structure of compact read-only optical disks (CD-ROM) for the information interchange between information processing systems.

ISO 9660 was originally released as the ECMA 119, with the same title.  ISO adopted the 2nd Edition of the ECMA document in 1988.  This is the first modification of the standard since that time.  The new amendment is intended to bring harmonization between ISO 9660:1988 and widely used “Joliet Specification.”   It is 18 pages in length, so the update is extensive.

Changes to ISO 9660 center on the addition of an Enhanced Volume Descriptor.  You’ll be able to find a complete list of how this addition modifies the document in the 4-page Annex B.

ISO 9660 is one of the many ISO standards available from Document Center Inc. at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Territorial restrictions may apply.  We’ve been an authorized reseller of ISO standards since the 1990’s and can assist you with any questions or requirements you may have.

 

New ASME B16.5 2013 Edition for Pipe Flanges and Flanged Fittings

There’s a new ASME B16.5 2013 Edition, “Pipe Flanges and Flanged Fittings: NPS 1/2 through NPS 24 Metric/Inch Standard.”  You can order it now from Document Center Inc.  The new revision covers pressure-temperature ratings, materials, dimensions, tolerances, marking, testing, and methods of designating openings for pipe flanges and flanged fittings.

ASME B16.5 is limited to flanges and flanged fittings made from cast or forged materials, and blind flanges and certain reducing flanges made from cast, forged, or plate materials. Also included in this Standard are requirements and recommendations regarding flange bolting, flange gaskets, and flange joints.

Included are:

  • flanges with rating class designations 150, 300, 400, 600, 900, and 1500 in sizes NPS 1/2 through NPS 24 and flanges with rating class designation 2500 in sizes NPS 1/2 through NPS 12, with requirements given in both metric and U.S. Customary units with diameter of bolts and flange bolt holes expressed in inch units;
  • flanged fittings with rating class designation 150 and 300 in sizes NPS 1/2 through NPS 24, with requirements given in both metric and U.S. Customary units with diameter of bolts and flange bolt holes expressed in inch units; and
  • flanged fittings with rating class designation 400, 600, 900, and 1500 in sizes NPS 1/2 through NPS 24 and flanged fittings with rating class designation 2500 in sizes NPS 1/2 through NPS 12 that are acknowledged in Non-Mandatory Appendix E (with U.S. Customary units only.)

Document Center Inc. has been a reseller of the ASME standards since the 1980’s.  You can purchase all current ASME standards and many obsolete editions at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  We’re here to assist you with all your standards requirements.

New ASTM D4332 2013 for “Conditioning” Packages Prior to Testing

There’s a new ASTM D4332 2013 Edition, “Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing,” and you can buy it now from Document Center Inc.  The standard covers the set up of standard and special conditioning and testing atmospheres to simulate particular field conditions that can affect a container, package, or packaging component while in use.

The reason that this test is useful is because many materials used for containers and packages (for example, cellulosic materials) are impacted by changes in the surroundings like  temperature and relative humidity (RH).  Once the package has been brought up to the condition that it is expected to encounter in use, then the required packaging  tests can be run.

FYI: If you are testing fibreboard, you’ll need the ASTM D685 for the preconditioning requirement.

It’s been seven years since the ASTM D4332 was reviewed and twelve since it’s been revised.  The previous ASTM D4332-01(R2006) Edition is now obsolete and replaced by the new ASTM D4332-13 Edition.

Want to see more standards on packaging?  Take a look at our page for the ICS Code 55.020.  It has a wide variety of packaging standards that you can purchase from Document Center Inc.

Order standards on our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) if you prefer to work with one of our customer service reps.  You’ll find we can help you with both the purchasing process and with any questions you may have about the standards you use.