New ISO/TR 10993-33 – Supplement for Part 3

ISO/TR 10993-33, “Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3,” has just been released.  It’s available from Document Center in paper format, for pdf download, and as part of our multi-user Standards Online service.  It will give you an overview of the differences in various regulatory bodies regarding genotoxicity testing.  And it will help you choose what tests to use and provides guidance on the performance of those tests.

What are genotoxicity tests?  They are used to detect compounds that induce genetic damage, either directly or indirectly.  This is necessary because such compounds can be carcinogenic or may create germ line mutations (which can cause human disease).

The ISO/TR 10993-33 has the usual scope clause and then dives directly into the issue of what tests are commonly recognized for use by most regulatory agencies.  This general information is linked to the various clauses in the technical report, so for bacterial reverse mutation test the user is directed to clause 6 and OECD 471.  Clauses 4 and 5 cover an overview of both in vitro and in vivo tests.

Then the report clauses 6 to 11 cover six different tests.  Each is given a general overview, preparations, test conditions, procedure and data and reporting sections.  The six tests are:

  • Bacterial reverse mutation assay
  • In vitro mammalian chromosome aberration test
  • In vitro mammalian micronucleus test
  •  In vitro mammalian cell gene mutation test using mouse lymphoma (L5278Y) cells
  • In vivo mammalian erythrocyte micronucleus test
  • Chromosome aberration test (in vivo)

A 33-item bibliography completes the publication.

As you can see, the document is highly technical, but offers the user detailed information that is not found in the shorter ISO 10993-3.  Indeed, the bulk of the ISO/TR 10993-33 supplement is devoted to the tests themselves which will surely add clarification and detail to anyone currently using the Part 3.

Now you’ll want to get a copy.  You can order online at the Document Center webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been an authorized dealer of the ISO standards since the early 1990’s and selling standards from our Silicon Valley headquarters since 1982.  Make us your Standards Experts!

New ISO 10993-3 3rd Edition – Biological Evaluation of Medical Devices

Medical device manufacturers need to do a battery of testing prior to the release of any products as part of regulatory and quality requirements.  Biological evaluation, the interaction of the device with biological tissues, is a major concern.  So those in the medical device industry will want to know that there’s a new 3rd Edition available for ISO 10993-3.  Titled “Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity,”  this is part of the 19-document series from ISO.  It is a technical revision of the 2nd edition (which is now obsolete) and is 42 pages in length compared to the previous 23 page revision.

What are the changes in the ISO 10993-3 3rd Edition?  As you can see from the additional pages, there’s a lot of new material.  Let’s review the areas where the standard has been updated:

  • The test strategy of the standard has been modified by the addition of an in vivo test and follow-up evaluation.
  • There’s a new Annex A which provides guidance on selecting the appropriate sample preparation procedure in genotoxicity testing.  This includes further in vitro and in vivo tests.
  • There’s also a new Annex B that’s a flowchart for follow-up evaluation.
  • Annex E has been changed to “Considerations for carcinogenicity studies performed as implantation studies.”  This is a requirement now, not just informative.
  • And there’s a new Annex F on in vitro tests for embryo toxicity as well.

Other news for those of you who use this standard — A new ISO 10993-33 is in the works.  When it is published, it is expected that the title will be “Biological evaluation of medical devices – Part 33:  Supplement to ISO 10993-3: – Guidance on tests to evaluate genotoxicity.”  The document should be released as a Technical Report.

You’ll want to purchase a copy of the new edition, so head to the Document Center Inc. website at www.document-center.com and order your copy now.  You’ll be able to get the standard in both paper format and for pdf download.  If you’d like to have it as part of our Standards Online multi-use subscription service, contact our staff by phone (650-591-7600), email (info@document-center.com) or fax (650-591-7617).  We’re here to assist you with your compliance documentation requirements.  Make us 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 10993-8Withdrawn – 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.