Introduction
Hello,
We are thrilled to present the latest edition of Patient Guard newsletter, your go-to source for the most current updates for medical device and in vitro diagnostic (IVD) regulations and standards.
Thank you for your continued trust and partnership. We hope you find this edition of our newsletter both informative and valuable. As always, we welcome your feedback and are here to support you in any way we can.
Kind regards,
The Patient Guard Team
UK
USA
New & Updated Medical Device Standards - October 2024
ISO 8536-13:2024 – Infusion equipment for medical use – Graduated flow regulators for single use with fluid contact
BS EN ISO 7199:2024 – Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
BS EN IEC 61674:2024 – TC – Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
BS EN IEC 60601-2-33:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
