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Welcome to our News Letter
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
No Recent Updates from the FDA – Notice stating the organisation is going through reorganisation
New & Updated Medical Device Standards
- ISO 10993-23:2021/Amd 1:2025 – Biological evaluation of medical devices — – Part 23: Tests for irritation. AMENDMENT 1: Additional in vitro reconstructed human epidermis models
- ISO 1135-4:2025 – Transfusion equipment for medical use – Transfusion sets for single use, gravity feed
- ISO 1135-5:2025 – Transfusion equipment for medical use – Transfusion sets for single use with pressure infusion apparatus
- ISO/DIS 15747 – Plastic containers for intravenous injections
- IEC 61847:2025 – Ultrasonics. Surgical systems. Measurement and declaration of the basic output characteristics
- BS 7505:2025 – TC – Elastic properties of flat, non-adhesive, extensible fabric bandages. Specification
- ISO 14644-5:2025 – Cleanrooms and associated controlled environments – Operations
- ISO 9917-1:2025 – Dentistry. Water-based cements -Acid-base cements
- BS EN ISO 18374:2025 – Dentistry. Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis. Data generation, data annotation and data processing
- BS EN ISO 15883-1:2025 Washer-disinfectors – General requirements, terms and definitions and tests
- BS ISO 7176-25:2022+A1:2025 – Wheelchairs – Lead-acid batteries and chargers for powered wheelchairs. Requirements and test methods
- BS EN ISO 15883-3:2025 – Washer-disinfectors -Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
- BS ISO 5868:2025 – Ophthalmic optics and instruments. Anomaloscopes for the diagnosis of red-green colour vision deficiencies
- BS EN ISO22675:2025 – TC – Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
- BS EN ISO 15883-2:2025 – Washer-disinfectors -Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
- BS EN ISO 15883-7:2025 – TC – Washer-disinfectors -Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
