Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

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What is BS EN ISO 10993-18:2020+A1:2023 - Chemical characterization of medical device materials about?

Relevant to the safety of medical materials and devices, BS EN ISO 10993-18:2020+A1:2023 is an amended international standard on how to identify, quantify and control biological risks from the material constituents of medical devices.

Who is BS EN ISO 10993-18:2020+A1:2023 - Chemical characterization of medical device materials for?

  • Manufacturers and suppliers of medical devices
  • Medical laboratories
  • Regulatory authorities
  • Notified bodies

What does BS EN ISO 10993-18:2020+A1:2023 - Chemical characterization of medical device materials cover?

BS EN ISO 10993-18 outlines the chemical characterization of medical device materials within a risk management process. It specifies a framework for the identification and quantification of constituents of a medical device, allowing the identification of biological hazards. It estimates and controls the biological risks from material constituents, using a generally stepwise approach to the chemical characterization.

Chemical characterization in BS EN ISO 10993-18 includes the identification of materials of construction, the characterization of the materials of construction via the identification and quantification of their chemical constituents, the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions, and the measurement of chemical substances released from a medical device under its clinical conditions of use.

Why should you use BS EN ISO 10993-18:2020+A1:2023 - Chemical characterization of medical device materials?

  • It contributes to the development of safe medical devices
  • It gives users an efficient and effective process for risk assessment including guidance on assessing material, hypothetical worst-case, the analytical evaluation threshold, chemical release and exiting the chemical characterization process
  • It provides one means of conformance with the relevant EU Directives
  • It can strengthen organizational risk management
  • It can increase market confidence in products

What’s new about BS EN ISO 10993-18:2020+A1:2023?

This is an amendment to BS EN ISO 10993 18:2020. The major change in BS EN ISO 10993-18:2020+A1:2023 is that the equation E.2 as published in ISO 10993-18:2020 will lead to materially false conclusions for the appropriate uncertainty factor (UF) and could therefore lead to incorrect conclusions regarding medical device safety. It could also create confusion in the medical device industry regarding best practice in calculation of the UF. This amendment refers to what best practice actually is regarding calculation of the UF in the medical device industry.