ISO/TR 10993-22 for Nanomaterials Released

ISO/TR 10993-22 has just been released.  It’s titled Biological evaluation of medical devices – Part 22: Guidance on nanomaterials.  This important new addition to the 10993 series is available now from Document Center Inc.  It can be purchased in paper format, for pdf download, and as part of our enterprise Standards Online subscription service.

Nanomaterials are bringing revolutionary new properties to many product lines.  These materials will surely have an impact on the medical device industry.  However, potential toxicity issues must be addressed.  ISO/TR 10993-22 provides you with guidance on how to proceed.

What are nano-objects (the particles of nanomaterial addressed in this technical report)?  These are particles having a length range from 1 nm to 100 nm.  Since medical device manufacturers will have various points in the lifecycle where folks will come in contact with these objects, risk evaluation needs to address a number of situations.  These include preparation, use, wear, or degradation of the device.

Who should be using the ISO/TR 10993-22?  Medical device industry individuals with training in medical device evaluation will find this report to be essential. This is because nanomaterials have specific challenges during the testing process and when evaluating results.

What’s covered in this report?  It provides you with an ISO 10993 risk management process for medical devices that contain, generate or are composed of nanomaterials.  After the usual scope, referenced documents, and definition sections, general principles are reviewed.  The report then moves on to the physicochemical characterization of nanomaterials.   This is to determine the chemical composition, the physical description and extrinsic properties.

Section 6 covers the preparation of samples.  While many of the requirements are in ISO 10993-12, there still are special concerns with regards to nanomaterials.  The next several sections cover additional considerations.  These include the release of nano-objects from medical devices, toxicokinetics and toxicological evaluation.  Section 10 shows how to present the characterization and test results.  Section 11 specifically addresses risk assessment.  The biological evaluation report is reviewed in Section 12.  A lengthy 272-item bibliography completes the 68-page document.

If you’re using or considering using nanomaterials in your medical device(s), you’ll want a copy of this new publication.  Choose Document Center Inc. for your purchase.  We are an authorized distributor of the ISO standards.  Find them at our webstore, www.document-center.com.  Or go directly to the order page for ISO/TR 10993-22.  Here is a complete list of the ISO 10993 series standards.

Document Center Inc. has been working with standards since 1982.  You’ll find our staff to be knowledgeable.  And we have a wide range of products and services specifically designed to address your compliance concerns.  Reach us by phone (650-591-7600) or email (info@document-center.com).  Make us your Standards Experts!

Published by

Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

Leave a Reply

Your email address will not be published. Required fields are marked *