Welcome to our News Letter
Happy New Year!
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
Regulatory News - December 2024
EU
UK
USA
New & Updated Medical Device Standards
ISO 14607:2024 – Non-active surgical implants. Mammary implants. Specific requirements
ISO 23908:2024 – Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements and test methods
ISO 22675:2024 – Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
IEC 60601-2-39:2024 – Medical electrical equipment. – Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment
IEC 60601-2-40:2024 – Medical electrical equipment. – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
BS ISO 19045-2:2024 – Ophthalmic optics. Contact lens care products – Method for evaluating disinfecting efficacy by contact lens care products using trophozoites of Acanthamoeba species as the challenge organisms
BS EN ISO 11199-2:2021+A1:2024 – Assistive products for walking manipulated by both arms. Requirements and test methods – Rollators
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
BS EN ISO 15004-2:2024 – TC – Ophthalmic instruments. Fundamental requirements and test methods – Light hazard protection
BS EN ISO 14630:2024 – TC – Non-active surgical implants. General requirements
