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
- Webinar – FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs), October 24, 2024
Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A – October 30, 2024
Federal Register: Chemical Analysis for Biocompatibility Assessment of Medical Devices
Safety and Performance Based Pathway (Updated)
Federal Register: Medical Devices: Quality System; Correction
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
