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 5364 (Standard)
Anaesthetic and Respiratory Equipment
Oropharyngeal airways
Date: 2026-06
DIN EN ISO 15883-6 (Standard)
Washer-disinfectors
Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (ISO 15883-6:2026); German version EN ISO 15883-6:2026
Date: 2026-06
ISO 3630-8 (Standard)
Dentistry
Endodontic instruments - Part 8: Accuracy of electronic apex locator
Date: 2026-06
ISO 7554-3 (Standard)
Surgical instruments
Terms, measuring methods and test methods - Part 3: Test methods
Date: 2026-06
DIN EN ISO 11987 (Standard)
Ophthalmic optics
Contact lenses - Determination of shelf-life (ISO 11987:2026); German version EN ISO 11987:2026
Date: 2026-06
DIN EN ISO 11138-6 (Draft)
Sterilization of health care products
Biological indicators - Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes (ISO/DIS 11138-6:2026); German and English version prEN ISO 11138-6:2026
Date: 2026-06
DIN EN ISO 21606 (Draft)
Dentistry
Elastomeric auxiliaries for use in orthodontics (ISO/DIS 21606:2026); German and English version prEN ISO 21606:2026
Date: 2026-05
DIN EN ISO 22523 (Draft)
External limb prostheses and external orthoses
Requirements and test methods (ISO/DIS 22523:2026); German and English version prEN ISO 22523:2026
Date: 2026-06
ISO/AWI TS 11967 (Projekt) (English Only)
Biological evaluation of medical devices
Guidance on commissioning scientifically robust chemical characterization testing in accordance with ISO 10993-18
Date: 2026-06-23
DIN EN ISO 14155 rev (Project)
Clinical testing of medical devices on humans
Good clinical practice
Date: 2026-06-29
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