AAMI TIR28 Updated for Ethylene Oxide Sterilization

AAMI TIR28 has been updated.  The new 22-page 2016 Edition is titled Product adoption and process equivalence for ethylene oxide sterilization.  It is a Technical Information Report.  It is intended to be used in conjunction with ANSI/AAMI/ISO 11135 from 2014.  It provides information on correctly sterilizing medical equipment in healthcare environments.

The AAMI TIR28 provides guidance on how to bring new or modified products into an existing validated sterilization process.  One part of this process involves establishing equivalence between the existing processes and the level of microbiological performance required for the new items.  The Report also addresses maintenance of equivalence and requalification once that equivalence has been established.

Please note that AAMI TIR28 can be used for new products, changes to products that have already been validated, moving a validated process to a new facility or new equipment, and to evaluate the equivalency of a sterilization process.

The AAMI TIR28 was updated due to changes in the ISO standard that it applies to.  If you need copies of the AAMI Report or any relevant ISO standards, consider using Document Center Inc. for your purchase.  As an authorized distributor, Document Center Inc. offers you access to over 1 million publications at our webstore, www.document-center.com.  Here is a direct link to the order page for AAMI TIR28 for your convenience.

What are the benefits of using Document Center?  First, we’ve been working with standards since 1982.  You’ll find our staff knowledgeable, ready to assist you with all your standards questions.  Second, our update notification service is best-in-class and comes free with every purchase.  And we have a wide range of products and services to assist you with your compliance documentation requirements.  This includes our Standards Online cloud access service for a company-wide solution for your organization.

To learn more, reach out to us by phone (650-591-7600) and/or email (info@document-center.com).  Learn why so many companies make us their Standards Experts!

ASTM E10 2017 Edition Released for Brinell Hardness

ASTM E10, Standard Test Method for Brinell Hardness of Metallic Materials, has been updated.  The new 2017 Edition is available from Document Center Inc. now.  You can purchase the document in a number of formats: paper, pdf download, redline, and as part of our Standards Online company access subscription.  This new update replaces the 2015a Edition, which is now obsolete.

I last blogged about the ASTM E10 when the 2015a Edition was released.  In that post, I review the Brinell Hardness test itself.  Check it out if you have questions about the content of the standard.

E10 is extensively used in industry.  So the new changes may impact your testing methods that reference this standard.  The ASTM Committee E28, which oversees this document, has highlighted the following areas where changes occur:

  • A Note A1.4 has been added
  • Sections A1.6.3.8, A1.6.4.9, and A2.8.1.8 have been revised
  • Table 1 has been updated
  • Section 3.2.2 has been added and Sections 3.2.3 and 3.2.5 have been revised
  • Tables A1.2 and A2.6 have been changed
  • Sections A4.5.3, A4.5.4, A4.5.1, A4.5.5, and A4.7.1.3 have been revised

The redline edition will provide you with both a clean copy and a copy of the previous edition with the changes clearly marked.  Look for the bold black lines in the margins of the redline copy.

Of course, if you’re using Standards Online the new Edition will automatically be posted to your account.  If not, you’ll want to purchase a copy now.  Head to Document Center’s webstore at www.document-center.com to search for and order ASTM standards from our collection of over 1 million publications.  Here is a direct link to the order page for ASTM E10.

If you’d like more information on the redline edition or on our Standards Online cloud service, just get in touch with us.  You can contact us by phone (650-591-7600) or by email (info@document-center.com).  We are an authorized distributor of ASTM standards and have been in business since 1982.  Make us your Standards Experts!

 

ISO 10993-16 Updated – Medical Device Toxicokinetic Studies

The ISO 10993 series on the biological evaluation of medical devices is used throughout the healthcare industry.  So updates to any of the standards in the series are important.  Document Center Inc. is pleased to announce that we have the new 3rd Edition of ISO 10993-16 available for purchase.  The standard is titled Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables.  It is used to develop studies on the impact of materials within the body over time.

Toxicokinetics is the study of the absorption, distribution, metabolism, and excretion of foreign compounds in the body.  So many medical device developers and manufacturers use it to evaluate the stability of the materials in their products.  It’s important to understand any potential hazards these devices pose.  Development of toxicokinetic studies that take factors like the nature and duration of the implant into account are critical.

The 20-page ISO 10993-16 gives the user the principles for designing and performing these types of studies.  Section 5 contains guidance on test methods to consider.  And Annex A reviews the types of circumstances that might make this type of study valuable.

For those of you already using this standard, you’ll want to know what the changes in this new edition are.  The committee points out the following revisions:

  • A definition in clause 3.1 has been updated for clarity
  • Modifications of both Clause 4 and Clause 5 have also been made, again for clarity
  • New information on toxicokinetic studies for nano-objects has been added
  • Annex section A.4 has been changed for the sake of clarification

FYI: This new ISO 10993-16 3rd Edition cancels and replaces the previous 2nd Edition from 2010.  It is considered a technical revision.

Now to get your copy of this new standard.  Head to Document Center’s webstore at www.document-center.com.  You can search for and order standards from our collection of over 1 million publications.  Here is a direct link to the order page for the new ISO 10993-16.

Many of our customers have questions about how to use standards, including transition times and what editions to choose.  Our knowledgeable staff members can answer these and many other concerns you may have.  And be sure to ask them about our range of services all geared to support your compliance requirements.  You can reach us by phone (650-591-7600) and/or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

What is the difference between ANSI Z540.1 and ANSI Z540.3?

The replacement of the ANSI Z540.1 with the ANSI Z540.3 and the ISO/IEC 17025 back in 2007 has led to a number of questions from Document Center Inc. customers.  To help you understand the situation, here’s a review of the migration path.  And we’ll discuss the differences between the ANSI Z540.1 and ANSI Z540.3 as we go.

Calibration is an essential activity in many organizations, including test labs and manufacturing firms with precision machinery.  Back in the day, the MIL-C-45662 Calibration System Requirements ruled the day.  This original Mil Spec was replaced by the standard MIL-STD-45662 in 1980.  However with Mil Spec reform in the 1990’s, the document was cancelled in favor of the ANSI-Z540.1 and ISO-10012.

ANSI Z540.1 was titled Laboratories, Calibration, and Measuring and Test Equipment.  Released in 1994, it consisted of 2 parts — the Part 1 was based on the old ISO/IEC Guide 25 (now ISO/IEC 17025).  The Part 2 was based on the MIL-STD-45662 Revision A.  So you can see that the document was a natural successor to the old military document.  However, it was developed specifically for calibration services, not testing labs.

The Part 1 directly addressed general requirements for the competence of calibration labs.  It applied to the development and implementation of a quality system.  For some situations, these older requirements may still be used when both the customer and the lab are in agreement.

With the release of the ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) in December 1999, there was an obvious overlap between the two standards.  In an effort to make it clear and easy for users, NCSL (the caretaker of the ANSI Z540 documents) decided to revamp the Z540 publication.  A new standard would take the place of the Part 2 while the ISO/IEC 17025 would be adopted for the material in Part 1.

The ANSI Z540.1 Part 2 addressed quality assurance requirements for a supplier’s system with regards to measurement accuracy.  This included calibration of test equipment.  It provided customers to be assured that the calibration lab was meeting the prescribed requirements.

The “new” ANSI Z540.3, Requirements for the Calibration of Measuring and Test Equipment, again establishes the technical requirements for the calibration of measuring and test equipment.  So you’ll get requirements for establishing and maintaining the performance of your measuring and test equipment.  The suitability of a calibration for the application is covered.  And the traceability of your measurement results to the International System of Units (SI) is included.

So to recap, the ANSI Z540.1 was an umbrella publication.  When the ISO/IEC 17025 was released, a new ANSI Z540.3 was issued just for the calibration requirements themselves.  The ISO/IEC document was adopted for the competence requirements.

If you need any of these publications, use Document Center Inc. for your purchase.  We have over 1 million standards for you to choose from at our webstore www.document-center.com.  Here are direct links to the order pages for ANSI Z540.3 and the ISO/IEC 17025.

Document Center Inc. has been working with standards since 1982.  We have a familiarity with standards that you’ll find at few other organizations.  Reach out to us by phone (650-591-7600) or email (info@document-center.com) with any questions you may have.  Our services support compliance needs of many companies around the world.  Make us your Standards Experts!

 

MIL-PRF-55110 Updated – Printed Wiring Boards

MIL-PRF-55110 has been updated.  The specification is titled Printed Wiring Board, Rigid, General Specification for.  The new Edition is Revision H with Amendments 1 and 2.  Compliance with this new edition must be completed by September 18, 2017.

The MIL-PRF-55110 was previously numbered MIL-P-55110 and is one of the major PWB (Printed Wiring Board) specifications for government contract work.  It was inactivated in December 1997 and should only be used for replacement purposes.  New design should meet the requirements of MIL-PRF-31032 (Printed Circuit Board/Printed Wiring Board, General Specification for), Revision C from 2016.

MIL-PRF-55110 provides you with the performance and qualification requirements for rigid single-sided, double-sided and multilayered printed wiring boards.  These boards can include both plated and non-plated through holes.  Four types of PWB’s are included in the document — that is, the single-sided, double-sided, multilayer with plated holes, and multilayer with plated and blind or buried via holes.

Changes in this new edition are clearly marked with black lines in the outside margin of the document.  You’ll find them on the following pages:

1, 7, 15, 17, 24, 28, 29, 30, 31, 32, 33, 36, 38, 40, 42, 47, 48, 51, 56, and 78.

If you’re familiar with this 134-page document, you’ll soon realize that the bulk of the new updates occur in Appendix A.

Our customers have been purchasing Mil Specs and Standards from us here at Document Center Inc. since our inception in 1982.  We offer fast service, an extensive collection of current and obsolete documents, and best-in-class notifications.  And we have a wide range of compliance support services for you as well.  You can search for and order standards at our webstore, www.document-center.com.  Or go directly to the order page for the MIL-PRF-55110 now.

Document Center Inc. provides you with conformance information from our Silicon Valley headquarters.  Our staff has been working with standards for many years.  You’ll find us to be knowledgeable about the documents we sell.  So we can help you understand many of the nuances that may be confusing.  We’re available by phone (650-591-7600) and email (info@document-center.com).  Get in touch with us now and learn why so many organizations make us their Standards Experts!

IPC 4101 Revision E Released

IPC 4101 Revision E was recently released.  This standard is titled, “Specification for Base Materials for Rigid and Multilayer Printed Boards.”  The new edition will replace revision D from 2015.  This specification lays out all the requirements for base materials, otherwise known as laminate or prepreg.  It’s available now from Document Center, Inc.

Base material selection is the first and perhaps most important step in PCB design.  IPC 4101 simplifies the process with its own well-defined callout system.  Each material’s specifications clearly define the material designator, specification sheet number, nominal laminate thickness, metal cladding type and nominal weight, thickness tolerance class, and surface quality class.

IPC 4101 revision E also includes a number of specification sheets.  These define requirements for each product grade of prepreg or laminate material.  In addition, the specification sheets carry the added benefit of connecting this revision to previous ones.

Additional sections of this document will guide you through some of the processes that occur after material selection.  Most importantly, these include provisions for quality assurance as well as packaging and transportation.  This thorough document is truly a must-have for PCB design.

Now, where do you get a copy?  Contact us at Document Center.  We’ve got this, as well as many other IPC standards available in a variety of formats.  We also honor IPC member pricing.  Stop by our website at www.document-center.com and browse our standards library.  Or, if you’d rather skip directly to the IPC 4101 order page, simply click here.

Not sure if IPC 4101 Revision E is the right standard for you? Call us any time with your questions, (650)591-7600 or send us an email at (info@document-center.com) and we’ll help you find the one you’re looking for.  Why Document Center?  We’ve been in the business of helping people acquire the right standards for 20 years.  Make us your Standards Experts!

MIL-STD-1541 Cancelled

MIL-STD-1541, Electromagnetic Compatibility Requirements for Space Systems, has been cancelled.  The standard has been replaced by 3 documents.  They are SMC-S-008, AIAA-S-121, and MIL-STD-464.  Each of these replacement documents covers the same basic material.  However, their applicability to any given application may vary.

MIL-STD-1541 was last updated with the release of Revision A in 1987.  The 42-page standard covered electromagnetic compatibility requirements like frequency management in space systems.

The replacement standards date from 2008 forward.  They are more extensive.  The AIAA-S-121 and SMC-S-008 share the same title (Electromagnetic compatibility requirements for Space Equipment and Systems).  The MIL-STD-464 is titled Electromagnetic environment effects requirements for systems.

FTI: The AIAA-S-121 is an industry standard, while the SMC-S-0008 and the MIL-STD-464 are both U.S. Military publications.

Once a MIL Standard like MIL-STD-1541 is cancelled, it is not valid for procurement.  While new revisions of some military documents may have a transition time, this is usually not the case for the cancellations.  If you’re a defense contractor, you’ll look to your procurement officer for guidance on which of the new replacement documents will be applicable moving forward.

If you need copies of any of the three replacement standards (or the cancellation notice!), you can purchase them from Document Center Inc.  Just use our webstore, www.document-center.com.  We have over 1 million standards for you to choose from, including many obsolete revisions.  And we are happy to help you determine what replacement documents should be used for withdrawn publications.

You can reach us by phone (650-591-7600) and by email (info@document-center.com).  We’ve been working with military specifications and standards since 1982.  Make us your Standards Experts!

SD-1 2017 Released

SD-1, Standardization Directory, has just been updated.  This is a U.S. Department of Defense administrative document.  The 188-page publication gives you complete information on who’s responsible for standardization activity within the DoD.  This includes names and addresses for caretakers and other relevant personnel.  This information is sorted by the forces and by FSC (Federal Supply Classification) categories.

Why use the SD-1?  The SD-1 is important to all of you using Mil Specs and Standards.  This is because it contains contact information for every administrator responsible for your documents.  If you identify an error or the need for an update, you’ll use the SD-1 to get the contact information needed to report your concerns.

You’ll find that each entry in the SD-1 has the name of each point of contact, the address, phone and fax numbers, along with a description of that person’s responsibilities.  Some of them work with documents in a wide range of FSC categories!

SD-1 information relates to the information you’ll find on your Mil Specs and Standards in the ASSIST database, as well.  If you’re not registered as an ASSIST user, you can still use the information in the Responsibilities field.  Just search for the Lead Standardization Activity contact by number in the SD-1.

The contacts in the SD-1 are usually helpful to those of us in the general public.  Getting feedback on the validity and accuracy of the specs and standards they’re responsible for is an important part of their job.  So you can consider these folks to be additional resources after your contracting officers and the guidance included in your contracts.

You should also be aware that not all of the people listed in the SD-1 are government employees.  The Standardization Program at the DoD is dependent on a number of civilian contractors as well.

Defense standardization relies on both internal and industry documentation in order to manage the procurement cycle for our armed services.  This is a professional organization, with a large number of dedicated individuals involved in a complex process.  Understanding the standards system can be exceptionally helpful to those of us who support the military and other government branches as suppliers.

Let us know if you have questions.  We have been working with Mil Specs and Standards since 1982.  Through our work as standards suppliers and experts, we have a network of contracts and a breadth of knowledge not often found.  We help many individuals just like you with issues that crop up when using compliance documentation.  So reach out to us by phone (650-591-7600) or email (info@document-center.com).

You’re welcome to search for and order standards from our webstore, www.document-center.com.  Our site has many tools for understanding standards and finding the documents you need.  You’ll soon see why so many people make us their Standards Experts!

ISTA Procedure 3B Revised

ISTA Procedure 3B has been revised. This standard is titled “Packaged-Products for Less-Than-Truckload (LTL) Shipment.”  It lays out test procedures for packaged products designed to be transported in mixed shipments.  You can purchase the 2017 edition now from Document Center Inc.

Packaged-products must be designed to meet the individual conditions of their shipping situations.  Procedure 3B lays out the specific tests for packages to be transported on a motor carrier with many other packaged-products.  The other shipments typically have differing destinations.  These are designated “Less-Than-Truckload” shipments.

Procedure 3B addresses a variety of packaging types.  These include standard shipments over and under 200 pounds, cylindrical packages, and palletized or skidded packages.  The tests are used to determine each package’s ability to stand up to the stresses of transportation.  Things like vibration, shock, and temperature variation are concerns.

This thorough document describes how to test each type of package.  Things like tip-over, fork-lift handling, and free-fall drop tests are covered, as well as many others.  This document also specifies which apparatuses are used, laboratory conditions, and reference standards. If you’re looking to learn more about the resilience of your LTL packaged-products, this standard is the one to use.

Do you need a copy of ISTA Procedure 3B?  Look no further than Document Center, Inc.  We’ve got this and many other ISTA standards available at the click of a button.  Get your ISTA standards instantly by PDF download or order yourself a hard copy.  Just head to our web store at www.document-center.com.  If you’d like to go directly to the order page for Procedure 3B, just click here.

If you need more information on the many standards we have, contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’re happy to help you with the many questions that may come up when purchasing your standards.  We also offer a variety of other services that can help you maintain your document library.  Make us your Standards Experts!

ISO 7886-1 – Hypodermic Syringes

ISO 7886-1, Sterile hypodermic syringes for single use – Part 1: Syringes for manual use, has been updated.  The new 2nd Edition is available from Document Center Inc. in both paper format and for pdf download.  This is part of the ISO 8776 series for hypodermic syringes used for humans.

Part 1 specifically addresses single-use manual syringes.  These syringes can be made with or without a needle.  They can be made of a number of types of materials.  The user typically fills and injects fluids using the needle, rather than as a pre-filled syringe.

The standard was originally released as the 1st Edition in 1993 and updated with a Corrigendum (correction sheet) in 1995.  So there is a lengthy list of updates in the new 2017 Edition.  These changes include:

  • A clarified scope paragraph
  • New referenced documents, terms and definitions
  • The component drawing of the syringe was clarified
  • General requirements have been included
  • Syringe test methods have been revised
  • Labeling requirement updated
  • Syringe lubricants have been clarified
  • The annex on materials was deleted
  • Annex E was replaced
  • Annex F was added

The previous 1st Edition of ISO 7886-1 has been adopted by the EU and the adoption of this new 36-page 2nd Edition is in the works.  It should be accepted at the Regional level at the end of the month.  Adoption and publication by each European Nation will follow.  Because it is part of the harmonized standards set for the old Medical Device Directive, I expect there will be a list for the replacement Regulation that includes your transition time as well.

Medical Device Standards like the ISO 7886-1 are integral to the successful operation of our healthcare system.  If this is your business and you need a copy of this new release, please use Document Center Inc. for your purchase.  We are an authorized distributor of ISO standards and many other conformance publications.  Use our webstore www.document-center.com to search for and order from our catalog of over 1 million records.  Here’s a direct link to the order page for the ISO 7886-1 for your convenience.

We also offer a wide array of support services for standards users and medical device companies.  If you need help identifying, collecting and using standards, get in touch with us.  Our staff is available to help you.  Reach out to us by phone (650-591-7600) or email (info@document-center.com).  We have been working with compliance documentation since 1982.  Make us your Standards Experts!