ASTM F1980 2016 Medical Device Packaging

ASTM F1980, “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices,” has been updated.  The new 2016 Edition is available now from Document Center Inc.  You can purchase it online in paper format or for pdf download.  A redline version for this standard is also available.  The guide provides you with the information you need to evaluate how your medical device’s sterile barrier packaging system holds up over time.

Why do you need to do the assessment provided by ASTM F1980?  Many packages for sterile medical devices have an expiration date.  This guide shows you how that date should be established.

Do you need to have the medical device inside the package when you test it?  Not necessarily.  The guideline shows you how to do an accelerated aging evaluation with or without the devices.  So if you’re in the process of new product development for example, this standard is still applicable.

When was the last time ASTM F1980 was updated?  The last revision was back in 2007.  That document was reapproved in 2011.  But the new 2016 Edition is a technical update and replaces the earlier edition in full.  You’ll need a copy of the new edition if you’re using this standard.

What are the changes are in this new update?  For the 2016 Edition, the main changes to this issue are found in Appendix X3.  The text portion of this section on relative humidity used in aging protocols has extensive changes.  They are marked for your convenience in the redline edition, which is available for a modest increase in price.  You can ask our staff for more information by reaching out to us by phone (650-591-7600) or email (info@document-center.com).

Since Document Center Inc. has been an authorized ASTM distributor since the 1980’s, you can search for an order the ASTM standards you need at our webstore, www.document-center.com.  Here is a direct link to the order page for the ASTM F1980 for your convenience.  And please note:  Many obsolete editions of the ASTM standards are available from Document Center Inc.  If you can’t find what you’re looking for at the ASTM website, check in with us.  We may have the edition you need.

Standards users appreciate the knowledgeable staff and broad range of standards available from Document Center Inc.  We have an array of supporting products and services all geared to make your life easier.  When you need compliance information, make us your Standards Experts!

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!