ISO 10993-4 Revised – Testing for medical device interaction with blood

ISO 10993-4, Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood, has been revised.  The new 3rd Edition is available now from Document Center Inc.  The standard is one of the critical ISO 10993 series on biological evaluation of medical devices, used around the world.  The new update replaces the previous 2nd Edition with Amendment 1.  It is a technical revision.

Medical devices have generated a revolution in healthcare, but they do come with hazards.  One of the most critical is any interaction a medical device can have with the patient’s blood.  Thrombosis is a critical risk, so all efforts must be made to reduce any material or mechanical dangers.  This risk reduction is confirmed by the use of specialized tests.

ISO 10993-4 contains these tests and the criteria for choosing the ones best suited to any identified risks.  It does this by defining a classification system for medical devices intended for use in contact with blood.  It provides the principles to use in evaluating this type of interaction.  And it provides you with the rationale for choosing specific tests for your product.  The details of each test are found in other test method documents.

Changes in this new revision are extensive.  A synopsis is found in the forward to the publication.  Some highlights include:

  • Modification to the definitions clause (including new definitions).
  • Tables 1 and 2 have been consolidated, as have Tables 3 and 4.
  • The Annexes have been renumbered and rewritten.  Additional information on mechanically-induced haemolysis is also added to Annex D (formerly Annex C.)
  • New Annexes cover complement testing and best test method practices, less common tests, and in vivo thrombosis.
  • Language has been refined throughout the standard.
  • the Bibliography has been reorganized and expanded.

If you use this standard, you’ll want to get your copy soon.  It’s available in paper format or for pdf download at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 10993-4 for your convenience.

ISO 10993-4 has been adopted by any number of jurisdictions, most notably in Europe.  If you’re using an EN edition, you can expect adoption of the new edition.  Since the process may take a while, you may want to get a copy of the ISO edition now, since it will be adopted without changes.

Document Center Inc. has been an authorized distributor of standards from around the world for many years.  You can order from us with confidence.  And you’ll be surprised at the many services we offer standards users like you.  To learn more about our best in class notification service, our cloud-based enterprise subscription solution, and our array of reporting services, get in touch!  We can be reached by phone (650-591-7600) or email (info@document-center.com).  You’ll soon learn why so many companies make us their 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 10993-8Withdrawn – 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.