Tag: ISO-10993-16

ISO 10993-16 Updated – Medical Device Toxicokinetic Studies

The ISO 10993 series on the biological evaluation of medical devices is used throughout the healthcare industry.  So updates to any of the standards in the series are important.  Document Center Inc. is pleased to announce that we have the new 3rd Edition of ISO 10993-16 available for purchase.  The standard is titled Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables.  It is used to develop studies on the impact of materials within the body over time.

Toxicokinetics is the study of the absorption, distribution, metabolism, and excretion of foreign compounds in the body.  So many medical device developers and manufacturers use it to evaluate the stability of the materials in their products.  It’s important to understand any potential hazards these devices pose.  Development of toxicokinetic studies that take factors like the nature and duration of the implant into account are critical.

The 20-page ISO 10993-16 gives the user the principles for designing and performing these types of studies.  Section 5 contains guidance on test methods to consider.  And Annex A reviews the types of circumstances that might make this type of study valuable.

For those of you already using this standard, you’ll want to know what the changes in this new edition are.  The committee points out the following revisions:

  • A definition in clause 3.1 has been updated for clarity
  • Modifications of both Clause 4 and Clause 5 have also been made, again for clarity
  • New information on toxicokinetic studies for nano-objects has been added
  • Annex section A.4 has been changed for the sake of clarification

FYI: This new ISO 10993-16 3rd Edition cancels and replaces the previous 2nd Edition from 2010.  It is considered a technical revision.

Now to get your copy of this new standard.  Head to Document Center’s webstore at www.document-center.com.  You can search for and order standards from our collection of over 1 million publications.  Here is a direct link to the order page for the new ISO 10993-16.

Many of our customers have questions about how to use standards, including transition times and what editions to choose.  Our knowledgeable staff members can answer these and many other concerns you may have.  And be sure to ask them about our range of services all geared to support your compliance requirements.  You can reach us by phone (650-591-7600) and/or email (info@document-center.com).  We’ve been working with standards since 1982.  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 10993-8 – 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.