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 4074 (Standard)
Natural rubber latex male condoms
Requirements and test methods
Date: 2026-03
DIN EN ISO 17117-1 2026-04 (Standard)
Health informatics
Terminologische Ressourcen – Teil 1: Merkmale (ISO 17117-1:2025); Englische Fassung EN ISO 17117-1:2025
Date: 2026-03
DIN EN 16616 (Standard)
Chemical disinfectants and antiseptics
Chemothermische Wäschedesinfektion – Prüfverfahren und Anforderungen (Phase 2, Stufe 2); Deutsche Fassung EN 16616:2022+A1:2025
Date: 2026-03
ISO 18739 (Standard)
Dentistry
Vocabulary of process chain for CAD/CAM systems
Date: 2026-03
DIN EN ISO 10993-1 (Standard)
Biological evaluation of medical devices
Teil 1: Anforderungen und allgemeine Grundsätze für die Beurteilung der biologischen Sicherheit im Rahmen eines Risikomanagementsystems (ISO 10993-1:2025); Deutsche Fassung EN ISO 10993-1:2025
Date: 2026-03
DIN EN ISO 19253 (Draft)
Sterilization of health care products
Moist heat - Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers (ISO/DIS 19253:2026); German and English version prEN ISO 19253:2026
Date: 2026-03
DIN EN ISO 11737-3 (Draft)
Sterilization of health care products
Mikrobiologische Verfahren – Teil 3: Prüfung bakterieller Endotoxine (ISO 11737-3:2023); Deutsche und Englische Fassung prEN ISO 11737-3:2026
Date: 2026-03
DIN EN ISO 9693 (Draft)
Dentistry
Kompatibilitätsprüfungen für metall-keramische und keramisch-keramische Systeme (ISO/FDIS 9693:2026); Deutsche und Englische Fassung prEN ISO 9693:2026
Date: 2026-03
ISO/IEC AWI TS 26312 (Project) (English Only)
Information technology
Artificial intelligence – Identification and treatment of bias in AI by healthcare organizations
Date: 2026-03-19
DIN 5346 (Project)
Surgical instruments
Emergency trays for acute surgical care of the severely injured
Date: 2026-03-16
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