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 15378 AMD 1 (Standard)
Primärpackmittel für Arzneimittel – Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP)
Änderung 1: Ergänzung zu klimabezogenen Maßnahmen
Date: 2024-02
DIN EN ISO 11607-1 (Standard)
Packaging for terminally sterilized medical devices
Part 1: Requirements for materials, sterile barrier systems and packaging systems
Date: 2024-02
DIN EN 455-3 (Standard)
Medical gloves for single use
Part 3: Requirements and testing for biological evaluation
Date: 2024-02
DIN EN ISO 4865-1 (Standard)
Dentistry - General requirements of hand instruments
Part 1: Non-hinged hand instruments
Date: 2024-02
DIN EN ISO 10993-17 (Standard)
Biological evaluation of medical devices
Part 17: Toxicological risk assessment of medical device constituents
Date: 2024-02
ISO/AWI 17510 (Project)
Medical devices - Sleep apnoea breathing therapy
Masks and application accessories
Date: 2024-02
ISO/AWI TS 16569 (Project)
Health informatics
Standardized Dataset for Exchanging Musculoskeletal Exercise Therapy Recommendations
Date: 2024-02
DIN EN 14348 rev (Project)
Chemical disinfectants and antiseptics
Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants
Date: 2024-02
DIN EN ISO 8536-16 (Project)
Infusion equipment for medical use
Part 16: Infusion sets for single use with volumetric infusion controllers
Date: 2024-02
DIN EN ISO 17510 rev (Project)
Medical devices - Sleep apnoea breathing therapy
Masks and application accessories
Date: 2024-02
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