Tag: ISO-10993-11

ISO 10993-11 Updated – Systemic Toxicity Testing for Medical Devices

ISO 10993-11, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity, has just been updated.  These types of tests help to confirm that a medical device is safe for the intended use.  The new 3rd Edition is available now from Document Center Inc.  This update cancels and replaces the previous 2006 2nd Edition.  It is a technical revision.

For those of you in the medical device industry, finding and mitigating potential adverse effects is a top priority.  Systemic toxicity is one of those effects you’ll need to address.  These include such problems as leachates from your device or materials.  The absorption and distribution of toxic materials from a medical device can cause concern.  So ISO 10993-11 addresses various toxicity tests you’ll use to conduct a systemic toxicity study.

ISO 10993-11 is arranged in the usual fashion.  There are sections on scope, referenced documents and terms at the start.  Then Section 4 review the various general considerations you’ll need to address at the start of your testing.

Section 5 covers acute systemic toxicity, while 6 discusses repeated exposure issues.  The publication then has 8 Annexes on relevant material, all informative. A 21-item bibliography completes the document.

For those of you already using this standard (and many of you are!), here is information on the changes in the 3rd Edition.   As the committee notes in the forward to the publication, there is a reduction in the group size for chronic toxicity testing (Table 1), Annex F is now Annex G and a new Annex F has been added, Annex H has also been added, and the Bibliography has been updated.

The ISO 10993-11 2006 Edition was adopted by the EU.  Adoption of this new edition is pending.  Upon publication, acceptance as a new harmonized edition is expected.

Now you’ll need to get a copy of the new Edition.  Choose Document Center Inc., an authorized distributor of the ISO Standards.  Order at our webstore, www.document-center.com.  Here is a direct link to the order page for the ISO 10993-11 for your convenience.

All ISO Standards are available as part of our Standards Online cloud-based access service.  To learn more, please get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982 and offer you a complete support service for compliance documentation.  Make Document Center your Standards Experts!

The ISO 10993 Series on Biological evaluation of medical devices

The ISO-10993 Series on Biological Evaluation of Medical Devices is an essential part of every Medical Device company’s standards collection.  They are among Document Center’s all-time best selling Medical Device Standards.

The ISO-10993 Parts cover a broad range of principles and tests for the biological evaluation of medical devices within a risk management process.  Medical devices are categorized by the nature and duration of the contact of the device with the body.  The series helps the user identify and evaluate existing relevant data, identify gaps using risk analysis, identify where further information is necessary, and provides guidance on needed testing.  It is a must-have series for medical device manufacturers, researchers, laboratories, and regulators.

New releases in this  series (dated in 2010) are the Corrigendum 1 (Correction Sheet) for the ISO-10993-1, the ISO-10993-10:2010, the ISO-10993-13:2010, and the ISO-10993-16:2010.

Here’s the complete list of 10993 Standards.

  • ISO 10993-1 – Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2 – Biological evaluation of medical devices Part 2: Animal welfare requirements
  • ISO 10993-3 – Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4 and Amd 1 – Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
  • ISO 10993-5 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-6 – Biological evaluation of medical devices Part 6: Tests for local effects after implantation
  • ISO 10993-7 – Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-8 – Withdrawn – Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests
  • ISO 10993-9 – Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10 – Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
  • ISO 10993-11 – Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-12 – Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
  • ISO 10993-13 – Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14 – Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15 – Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16 – Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-17 – Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18 – Biological evaluation of medical devices Part 18: Chemical characterization of materials
  • ISO/TS 10993-19 – Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
  • ISO/TS 10993-20 – Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices

The complete set can be purchased as a package as well (ISO-10993-Package).  Contact Document Center Inc. at 650-591-7600 or on our website at www.document-center.com.