New ISO/TR 15499 standard available on Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

ISO/TR 15499:2012, “Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process,” has just been released and is now available from Document Center Inc.  The new Technical Report provides guidance on conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.

This document can be used to better understand the requirements of ISO 10993-1 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 10993-1.  Biological evaluation is a design verification activity which is set in the context of broader risk management processes. This means ISO/TR 15499 includes guidance on the application of ISO 10993-1 in the context of risk management processes conducted according to the requirements of ISO 14971.

Guidance contained in this Technical Report can also be useful as background information for those representing risk management process assessors, conformity assessment bodies and regulatory enforcement bodies.

ISO standards are sold by Document Center Inc. under license agreement 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).  We can assist you with the standards questions and requirements that affect your business.

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!

There’s a new standard EP23 available for Laboratory Quality Control Based on Risk Management

CLSI has released a new standard, EP23, titled “Laboratory Quality Control Based on Risk Management; Approved Guideline.”  The document, available through Document Center Inc., provides guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.

CLSI, formerly known as NCCLS, is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community.

The new guideline EP23 compliments the ISO 14971, “Medical devices — Application of risk management to medical devices,” ISO 10993-1, “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process,” and ISO 20993, “Biological evaluation of medical devices — Guidance on a risk-management process.”  It shows the increasing emphasis on risk management as a component of quality control in the health care industry.

All standards mentioned can be purchased 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 can assist you in the challenge of compiling and maintaining your standards documentation.