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 80601-2-84 (Standard)
Medical Electrical Equipment
Teil 2-84: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Notfall- und Transportbeatmungsgeräten
Date: 2023-11
ISO 80601-2-12 (Standard)
Medical Electrical Equipment
Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege
Date: 2023-11
DIN EN ISO/IEEE 11073-10419 (Standard)
Health informatics - Personal health device communication
Teil 10419: Gerätespezifikation – Insulinpumpe
Date: 2023-11
DIN EN ISO 10993-18 (Standard)
Biological evaluation of medical devices
Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte
Date: 2023-11
ISO/AWI 8536-16 (Project)
Infusion equipment for medical use
Part 16: Infusion sets for single use with volumetric infusion controllers
Date: 2023-11
DIN EN ISO 10535/A11 (Project)
Assistive products - Hoists for the transfer of persons
Requirements and test methods
Date: 2023-11
ISO/CD 11193-2 (Project)
Medizinische Untersuchungshandschuhe zum einmaligen Gebrauch
Teil 2: Anforderungen an Handschuhe aus Polyvinylchlorid
Date: 2023-11
ISO/CD 11193-1 (Project)
Medizinische Untersuchungshandschuhe zum einmaligen Gebrauch
Teil 1: Spezifikation für Handschuhe aus Elastomerdispersion oder -lösung
Date: 2023-11
ISO/CD 17117-1 (Project)
Health informatics - Terminological resources
Part 1: Characteristics
Date: 2023-11
DIN VDE V 0750-2-52-2 (Project)
Medical Electrical Equipment
Part 2-52-2: Particular requirements for basic safety and essential performance of couches
Date: 2023-11
DIN EN ISO 10993-17/A1 (Project)
Biological evaluation of medical devices
Part 17: Toxicological risk assessment of medical device constituents - Amendment 1
Date: 2023-11
DIN EN ISO 23908 (Draft)
Schutz vor Stich- und Schnittverletzung – Anforderungen und Prüfverfahren
Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration
Date: 2023-11
Continue reading:
(2 Rating(s), average: 5.00 out of 5)
Loading...
