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 EN ISO 5361 (Standard)
Anaesthetic and Respiratory Equipment
Tracheal tubes and connectors (ISO 5361:2023, corrected version 2023-11); German version EN ISO 5361:2023
Date: 2024-11
ISO 15883-3 (Standard)
Washer-disinfectors
Part 3: Requirements and test methods for washer-disinfectors with thermal disinfection for containers for human excreta
Date: 2024-11
ISO 12870 (Standard)
Ophthalmic optics
Spectacle frames - requirements and test methods
Date: 2024-11
ISO 13404-1 (Standard)
Prosthetics and Orthotics
External orthoses and orthotic components - Use, functions, classification and description - Part 1: Orthoses for the lower limbs
Date: 2024-11
ISO 16971-1 (Standard)
Ophthalmic Instruments
Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye
Date: 2024-11
DIN EN ISO 80601-2-69 (Draft)
Medical Electrical Equipment
Part 2-69: Particular requirements for the safety, including essential performance, of oxygen concentrators (ISO/DIS 80601-2-69:2024); German and English version prEN ISO 80601-2-69:2024
Date: 2024-11
DIN EN ISO 10451 (Draft)
Dentistry
Contents of the technical documentation for dental implant systems (ISO/DIS 10451:2024); German and English Version prEN ISO 10451:2024
Date: 2024-11
DIN EN ISO 10993-4 rev (Project)
Biological evaluation of medical devices
Part 4: Selection of tests for interaction with blood
Date: 2024-11-04
DIN EN ISO 20126 rev (Project)
Dentistry
Manual toothbrushes – General requirements and test methods
Date: 2024-11-05
ISO/CD TS 16840-16 (Project)
Wheelchair seating
Part 16: Part 16: Terminology and concepts related to computer simulations and their applicability to assessing wheelchair seating and systems
Date: 2024-11-22
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