In March of 2017, the new ISO 18562 standard series was released. This four part standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. Some of the additional concerns will be addressed through the assessment of volatile organic compounds (VOCs), particulates, and leachable in condensate. The US FDA has recently recognized ISO 18562 parts 2 and 3 completely and portions of part 1 and 4. This series is meant to run as a perpendicular standard to the ISO 10993 standard suite providing supplemental testing and considerations for your overall Biological Safety Evaluation which should include a 3-step process: 1) Initial risk assessment – introduction of device, materials, processing, patient contact, areas of risk and mitigation steps; 2) Testing and risk assessments; and 3) Summary report concluding that the device is biocompatible.
What you’ll learn:
- Overview of what is covered in each part of ISO 18562
- Integration of ISO 18562 into Biological Safety Evaluation and pertinent ISO 10993 testing
- FDA recognition of ISO 18562: what was accepted and what was not