Respiratory medical devices: US FDA recognises ISO 18562
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Respiratory medical devices
are widely used in the field of medicine, but there is now growing
awareness of the potential for polymeric components in the gas pathways
to release harmful volatile organic compounds (VOCs).
For this reason, the scope
of the existing biocompatibility standard (ISO 10993) has been expanded
to include the monitoring of volatile chemicals released from
respiratory medical devices using ISO 18562.
Manufacturers can achieve a competitive advantage
ISO 18562, released in 2017, is now recognised by the US Food & Drug Administration and will become mandatory by 2020.
Manufacturers can submit
their products under ISO 18562, enabling them to demonstrate improved
product safety and give their brands a competitive advantage.
Explanation video and white paper
Markes has released a study
that describes an ISO 18562-compliant analytical setup. To find out more
about this work, watch the short video, or download the white paper.
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