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:
DIN EN ISO 80369-2 (Standard)
Small-bore connectors for liquids and gases in healthcare applications
Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06); German version EN ISO 80369-2:2024
Date: 2026-08
DIN EN ISO 10555-1 (Standard)
Intravascular catheters
Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023); German version EN ISO 10555-1:2023
Date: 2026-08
DIN EN ISO 14155 (Standard)
Clinical investigation of medical devices for human subjects
Good clinical practice (ISO 14155:2026); German version EN ISO 14155:2026
Date: 2026-08
ISO 80601-2-13:2022/AMD1:2026 (Standard)
Amendment 1 – Medical electrical equipment- Part 2-13:
Particular requirements for basic safety and essential performance of an anaesthetic workstation
Date: 2026-08
IEC 63203-403-1:2026 (Standard)
Wearable electronic devices and technologies
Part 403-1: Test method of surface electromyography sensors on forearm and hand for wearable applications
Date: 2026-08
DIN EN ISO 14729 (Draft)
Ophthalmic optics - Contact lens care products
Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO/DIS 14729:2026); German and English version prEN ISO 14729:2026
Date: 2026-08
DIN EN ISO 10993-4 (Draft)
Biological evaluation of medical devices
Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2026); German and English version prEN ISO 10993-4:2026
Date: 2026-08
DIN EN 18178-1 (Draft)
Respiratory infection prevention devices for self- and third-party protection
Part 1: Requirements, test methods, classification and marking; German and English version prEN 18178-1:2026
Date: 2026-08
DIN EN ISO 15854 (Project)
Dentistry
Casting and baseplate waxes (ISO 15854:2023); German version EN ISO 15854:2023
Date: 2026-08-06
DIN EN ISO 15004-1 rev (Project)
Ophthalmic instruments
Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
Date: 2026-08-27
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