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New Standards and Standards Projects in May

ISO 11228-3 (Standard) / ISO 8549-4 (Standard) / DIN EN ISO 10993-17 (Standard)

The list of new standards, current draft standards and projects is a selection that might be relevant for our clients. It therefore does not claim to be complete. The compilation has been made very carefully and serves as an overview for you. However, errors cannot be excluded, and we cannot assume any liability. The selection draws information from the following standards committees:

ISO 16571 AMD 1 (Standard)

Systems for evacuation of plume generated by medical devices

Amendment 1

Date: 2026-05

DIN EN ISO 6876 (Standard)

Dentistry

Endodontic sealing materials (ISO 6876:2025); German version EN ISO 6876:2025

Date: 2026-05

ISO 8325 AMD 1 (Standard)

Dentistry

Test methods for rotary instruments - Amendment 1

Date: 2026-05

ISO 11228-3 (Standard)

Ergonomics - Manual handling

Part 3: Repetitive movements and exertions of the upper limbs

Date: 2026-05

ISO 8549-4 (Standard)

Prosthetics and orthotics

Vocabulary - Part 4: Terms relating to limb amputation

Date: 2026-05

DIN EN ISO 10993-17 (Standard)

Biological evaluation of medical devices

Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023 + Amd 1:2025); German version EN ISO 10993-17:2023 + A1:2025

Date: 2026-05

ISO 12487 (Standard)

Medical Electrical Equipment

Clinical performance evaluation of clinical thermometers

Date: 2026-05

DIN EN ISO 20126 (Draft)

Dentistry

Manual toothbrushes - General requirements and test methods (ISO/DIS 20126:2026); German and English version prEN ISO 20126:2026

Date: 2026-05

ISO/IEEE DIS 11073-10419 (Project)

Health informatics 

Personal health device communication - Part 10419: Device specialization - Insulin pump

Date: 2026-05-13

ISO/AWI 7176-34 (Project)

Wheelchairs

Part 34: ISO 7176-44: Robotic wheelchairs - Requirements and test methods

Date: 2026-05-05


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