The Ministry of Food and Drug Safety published ｢Guidelines for evaluating physical and chemical properties of non-absorbable polymer materials for biological safety evaluation of medical devices｣ on April 08, 2024 to help prepare biological evaluation data for medical devices by explaining the requirements, evaluation principles, and processes of data on physical and chemical characteristics analysis data.
The guidelines for evaluating physical and chemical properties of non-absorbent polymer materials are briefly as follows.
1. Scope of application
Applies to all types of non-absorbable polymeric medical devices (direct and indirect contact medical devices) except for non-contact medical devices in accordance with ISO 10993-1:2018
2. Physical and chemical analysis and evaluation of medical devices
(1) Overview
: Physical and chemical analysis data are important basic data for the selection of toxicological risk assessment and additional biological test items of ISO 10993-17
(2) Purpose of the test
‣ Identification of components that make up a medical device
‣ Identification and quantification of the composition of each component that constitutes a medical device
‣ Identification and quantification of unknown substances that may occur during the manufacturing process
(e.g. release agents, additives, process contaminants, sterilization, sterilization residues)
‣ Estimating, identifying, and quantifying potential hazardous substances that may be released from medical devices
using medical device Extractables methods(Laboratory extraction conditions)
‣ Quantification of potentially hazardous substances that may be released under clinical use conditions
‣ Identification and/or quantification of degradation products (ISO 10993-13,14,15) test solutions
(3) Test method
‣ Configuration test for classification of non-absorbable polymers
: Perform the test according to ISO 10993-18:2020, Table 5 — Possible test methodologies for assessing the structural composition of medical device materials
‣ Testing for Extractables and Leachables
: Prepare test materials according to ISO 10993-12, a test method that can be used for Extractables screening and Leachables research on medical non-absorbable polymers.
Please refer to the attached document below for more information.
If you have any questions about medical device in Korea,
Please contact us with the below.
info@jnmglobal.net
ra@jnmglobal.net