Technical bulletin: An updated approach to E&L testing per ISO 10993-18:2020
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
Patient safety is the number one priority. Therefore, medical device manufacturers must ensure that their products do not contain any potentially harmful chemicals that might have found their way into formulations during the packaging or storage processes, or that might be leached in a clinical setting.
This is where ISO 10993-18:2020 guidance comes in. It outlines the chemical characterisation (aka E&L) tests that manufacturers must undertake to support the biological safety of their devices.
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