ISO 10993-18:2020 Biological evaluation of medical devices —
Part 18: Chemical characterization of medical device materials within a risk management process
In this article, we’ll be discussing ISO 10993-18:2020 – a standard that provides guidance on the chemical characterization of medical device materials. This is important in order to ensure the safety of patients and users, as well as to support a risk management process.
What is ISO 10993-18:2020?
ISO 10993-18:2020 provides guidance on the selection of appropriate tests and methods for the chemical characterization of medical device materials. This includes the identification and quantification of leachable chemicals from medical devices.
The standard is applicable to all types of medical devices, including those made from polymeric, metallic, and ceramic materials. It can also be applied to composite materials and coatings.
ISO 10993-18:2020 is part of a larger series of standards (ISO 10993-1 to ISO 10993-18) that cover the biological evaluation of medical devices.
What are the requirements of ISO 10993-18:2020?
ISO 10993-18:2020 provides requirements and guidance for the chemical characterization of medical device materials. It is intended to be used within a risk management process as part of the biological evaluation of medical devices.
The standard includes requirements for the identification and characterization of medical device materials, as well as guidance on selecting appropriate analytical methods. It also provides an overview of the types of information that should be considered when characterizing medical device materials.
ISO 10993-18:2020 is applicable to all types of medical devices, including those made from polymers, metals, ceramics, and composites.
What are the benefits of ISO 10993-18:2020?
There are many benefits of ISO 10993-18:2020, including:
- It provides guidance on how to determine the chemical composition of medical device materials.
- It helps to identify potential risks associated with the use of medical devices.
- It can help to improve the safety of medical devices.
- It can help to reduce the cost of developing and manufacturing medical devices.
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