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 8362-2 (Standard)
Injection containers and accessories
Part 2: Closures for injection vials
Date: 2024-03
ISO 17665 (Standard)
Sterilisation von Produkten für die Gesundheitsfürsorge – Feuchte Hitze
Requirements for the development, validation and routine control of a sterilization process for medical devices
Date: 2024-03
ISO 6273 (Standard)
Assistive products
Accessibility guidelines and requirements to survey the needs of persons with sensory disabilities for assistive products and services
Date: 2024-03
ISO 18562-3 (Standard)
Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
Teil 3: Prüfungen für Emissionen von flüchtigen organischen Verbindungen (VOCs)
Date: 2024-03
ISO 18562-4 (Standard)
Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
Teil 4: Prüfungen für herauslösbare Substanzen in Kondensaten
Date: 2024-03
ISO 18562-2 (Standard)
Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
Teil 2: Prüfungen für Emissionen von Partikeln
Date: 2024-03
ISO 18562-1 (Standard)
Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses
Date: 2024-03
ISO 16021:2024 (Norm) (English Only)
Absorbent incontinence products for urine and/or faeces
Basic principles for evaluation of single-use adult products from the perspective of users and caregivers
Date: 2024-03
DIN EN ISO 10535 Authorization 1 (Project)
Assistive products - Hoists for the transfer of persons
Requirements and test methods
Date: 2024-03
ISO/CD 15747 (Project)
Plastic containers for intravenous injections
Date: 2024-03
DIN EN ISO 10873 rev (Project)
Dentistry
Denture adhesive
Date: 2024-03
DIN EN ISO 15883-7 (Draft)
Washer-disinfectors
Teil 7: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen
Date: 2024-03
DIN EN ISO 9917-1 (Draft)
Zahnheilkunde – Wasserhärtende Zemente
Teil 1: Zemente, die beim Vermischen von Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden
Date: 2024-03
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