Frequently Asked Questions & Answers: ISO®10993

What is ISO®10993?

ISO® 10993 is an international standard created to facilitate international harmonization of test methods for biological evaluation of medical devices.

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Why did Henkel move from a USP CLASS VI to ISO® 10993 test program?

ISO® 10993 standards offer compliance at a global level. Therefore, device manufacturers outside the U.S. have globally accepted standards, as opposed to the USP Program used in the U.S.



Is there a regulation requiring Henkel to revalidate its medical device adhesives to ISO® 10993 on a regular basis?

There is no specific regulatory requirement regarding revalidation of our medical device adhesives. Henkel, as the industry leader, believes the revalidation is an important service to our customers in assuring continuity of compliance.



What controls does Henkel have in place after the product has been tested to ISO® 10993?

While Henkel has no specific regulatory obligations under ISO® 10993, we perform the following:

  •  Each batch of Loctite® medical device adhesive is validated by Henkel's Quality Control Department to include all raw material inputs, intermediates and raw material manufacturers, as well as compliance to the product formulation.
  • Ensure that no changes will be made to composition materials or significant changes in our processes without notifying customers who have a specification on file requesting such notification.

 




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