November 2024 News Letter

Welcome to our November 2024 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued.
Patient Guards November 2024 News Letter
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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

Regulatory News - November 2024

EU

UK

USA

New & Updated Medical Device Standards - November 2024

    • ISO 15883-1:2024 – Washer-disinfectors – General requirements, terms and definitions and tests

    • ISO 11334-4:2024 –  Assistive products for walking, manipulated by one arm. Requirements and test methods – Walking sticks with three or more legs

    • BS EN 455-1:2020+A2:2024 – Medical gloves for single use – Requirements and testing for freedom of holes

    • BS EN 60601-2-3:2015+A2:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of short-wave therapy equipment

    • BS EN 60601-2-6:2015+A2:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of microwave therapy equipment

    • BS EN ISO 8536-13:2024 – TC – Infusion equipment for medical use – Graduated flow regulators for single use with fluid contact

    • BS EN ISO 12312-1:2022+A11:2024 – Eye and face protection. Sunglasses and related eyewear – Sunglasses for general use

    • BS EN IEC 80601-2-49:2018+A1:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of multifunction patient monitors

    • BS EN ISO 25539-3:2024 – Cardiovascular implants. Endovascular devices – Vena cava filters

    • BS EN ISO 14356:2024 – Dentistry. Duplicating material

    • BS EN 1865-6:2024 – Patient handling equipment used in ambulances – Powered chair

    • BS EN ISO 18562-4:2024 – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Tests for leachables in condensate

    • BS EN ISO 18562-1:2024 – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Evaluation and testing within a risk management process

    • BS EN ISO 18562-2:2024 – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Tests for emissions of particulate matter

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