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!
