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 VDE V 0750-2-52-2;VDE V 0750-2-52-2:2024-05 (Standard)
Medical Electrical Equipment
Teil 2-52-2: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Liegen
Date: 2024-05
DIN EN ISO 80601-2-94 (Project)
Medical Electrical Equipment
Part 2-94: Particular requirements for basic safety and essential performance of inhalational therapy nebulizer equipment
Date: 2024-05
DIN EN ISO 14155 (Project)
Clinical testing of medical devices on humans
Good clinical practice
Date: 2024-05
DIN EN ISO 8871-5 (Draft)
Elastomeric parts for parenterals and for devices for pharmaceutical use
Teil 5: Funktionelle Anforderungen und Prüfung
Date: 2024-05
DIN EN ISO 15378/A1 (Draft)
Primary packaging materials for medicinal products
Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP)
Date: 2024-05
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