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BSI Standards – Update on Projects Jan/Feb 2026
Status Date Description Committee
Published 31/12/2025 BS EN ISO 1135-4:2025 Transfusion equipment for medical use. Transfusion sets for single use, gravity feed CH/212 – IVDs
Published 31/12/2025 BS EN ISO 1135-5:2025 Transfusion equipment for medical use. Transfusion sets for single use with pressure infusion apparatus CH/212 – IVDs
Published 31/01/2026 BS EN IEC 60601-2-22:2020+A11:2026 Medical electrical equipment. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment EPL/76 – Optical radiation safety and laser equipment
Published 31/01/2026 BS EN IEC 60601-2-57:2026+A11:2026 Medical electrical equipment. Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use EPL/76 – Optical radiation safety and laser equipment
Published 31/01/2026 BS EN ISO 11987:2026 Ophthalmic optics — Contact lenses — Determination of shelf-life CH/172/9 – Contact lenses and contact lens care products
Published 31/01/2026 BS EN ISO 11986:2026 Ophthalmic optics. Contact lenses and contact lens care products. Determination of preservative uptake and release CH/172/9 – Contact lenses and contact lens care products
Published 31/01/2026 BS IEC 63465:2026 Calibration and quality control in the use of radionuclide calibrators CH/62/3 – Equipment for radiotherapy, nuclear medicine and radiation dosimetry
Published 07/02/2026 BS EN ISO 18969 Clinical evaluation of medical devices CH/194 – Biological evaluation of medical devices
Draft for public comment 09/02/2026 BS ISO 21064 Prosthetics and orthotics — Foot orthotics (pedorthics) — Uses, functions classification and description CH/168 – Prosthetics and orthotics
Draft for public comment 09/02/2026 BS EN ISO 80601-2-56 Medical electrical equipment —. Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement CH/121/9 – Lung Ventilators & Related Equipment
Draft for public comment 11/02/2026 BS 8599-1:2019+A1:2026 Workplace first aid kits – Specification for the contents of workplace first aid kits CH/100 – Healthcare and Medical Equipment
Draft for public comment 08/03/2026 BS EN ISO 18730 Anaesthetic and respiratory equipment — Waste volatile anaesthetic agent capture systems CH/121/1 – Breathing attachments and anaesthetic machines
Draft for public comment 10/03/2026 BS EN 868-9 Packaging for terminally sterilized medical devices. Part 9: Uncoated nonwoven materials of polyolefines – Requirements and test methods CH/198 – Sterilization and Associated Equipment and Processes
Draft for public comment 10/03/2026 BS EN 868-10 Packaging for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines – Requirements and test methods CH/198 – Sterilization and Associated Equipment and Processes
Draft for public comment 10/03/2026 BS EN 868-5 Packaging for terminally sterilized medical devices. Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods CH/198 – Sterilization and Associated Equipment and Processes
Draft for public comment 10/03/2026 BS EN 868-8 Packaging for terminally sterilized medical devices. Part 8: Re-usable sterilization containers for large steam sterilizers. Requirements and test methods CH/198 – Sterilization and Associated Equipment and Processes
Published 10/03/2026 BS EN ISO 11117:2019/Amd 1 Gas cylinders — Valve protection caps and guards — Design, construction and tests – Amendment 1: Gas cylinders — Valve protection caps and guards — Design, construction and tests — Amendment 1 PVE/3/1 – Gas containers – Valve fittings for gas containers
Draft for public comment 17/03/2026 BS EN ISO 23401-1 Dentistry — Denture lining materials — Part 1: Hard type materials CH/106/2 – Prosthodontic materials
Draft for public comment 21/03/2026 BS EN ISO 23401-2 Dentistry — Denture lining materials — Part 2: Soft type materials for short-term use CH/106/2 – Prosthodontic materials
Draft for public comment 21/03/2026 BS EN ISO 23401-3 Dentistry — Denture lining materials — Part 3: Soft type materials for long-term use CH/106/2 – Prosthodontic materials
Draft for public comment 30/03/2026 BS EN ISO 17254 Dentistry — Coil springs for use in orthodontics CH/106/1 – Dental restorative and orthodontic materials
Draft for public comment 31/03/2026 BS EN ISO 11737-3 Sterilization of health care products. Microbiological methods. Part 3: Bacterial endotoxin testing CH/198
       
*no new proposals for the period    

 

Ben Kemp