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Prepare for the New ISO 10993-10 : 2021

ISO 10993-10:2021 "Biological evaluation of medical devices - Part 10: Tests for skin sensitization"




ISO 10993-10:2021 "Biological evaluation of medical devices - Part 10: Tests for skin sensitization" has been approved and published.


Biological safety evaluation is very important to demonstrate the overall safety of a medical device. ISO 10993-23:2021 is a standard that specifies procedures for assessing the irritation potential of medical devices, materials or their extracts.


This standard replaces ISO 10993-10:2010 and is focused only on skin sensitization while

skin irritation assessment is documented through ISO 10993-23:2021.


Commonly, manufacturers make use of the ISO 10993 series of standards to assess the potential biological risks of their medical devices. Until recently, this series consisted of

21 standards, including technical reports and specifications, developed by the ISO

Technical Committee 194, Biological and clinical evaluation of medical devices (ISO/TC 194).


FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into direct contact or indirect contact with the human body in order

to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.


One of most relevant changes of this new standard states that where appropriate, the preliminary use of in vitro methods is encouraged for screening purposes.


This document presents a step-wise approach, with review and analysis of test results at each stage.


This is a change in mindset for which industry needs to prepare – fabricants need to be receptive and responsive to the new methods.



Provision Consulting Group provides consulting service and solves customer problems accurately and quickly.


Our services allow manufacturers to spend more time developing their devices

rather than searching for distributors, negotiating contracts, and learning regulations.



If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

please CONTACT US.


Office 1-909-493-3276

Email ask@provisionfda.com



SOURCE :

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and