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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.
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The Patient Guard Team
Regulatory News - December 2024
EU
UK
USA
New & Updated Medical Device Standards
ISO 15883-3:2024 – Washer-disinfectors – Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
ISO 15883-2:2024 – Washer-disinfectors – Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
ISO 12870:2024 – Ophthalmic optics. Spectacle frames. Requirements and test methods
ISO 80369-20:2024 – Small-bore connectors for liquids and gases in healthcare applications – Common test methods
BS ISO 16971-1:2024 – Ophthalmic instruments. Optical coherence tomographs – Optical coherence tomographs for the posterior segment of the human eye
BS EN ISO 11979-2:2024 – TC – Ophthalmic implants. Intraocular lenses – Optical properties and test methods
BS ISO 21474-3:2024 – In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids – Interpretation and reports
BS EN 556-2:2024 – TC – Sterilization of medical devices. Requirements for medical devices to be designated “STERILE” – Requirements for aseptically processed medical devices
