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 21649 (Standard)
Needle-free injection systems for medical use
Requirements and test methods
Date: 2023-06
ISO 11737-3 (Standard)
Sterilization of health care products
– Microbiological methods
Part 3: Testing of bacterial endotoxins
Date: 2023-06
ISO 80601-2-72
Medical Electrical Equipment
Part 2-72: Particular requirements for the safety, including essential performance, of home ventilation equipment for device-dependent patients
Date: 2023-06
ISO 24072
Aerosol bacterial retention test method for air-inlet filter on administration devices
Date: 2023-06
DIN EN ISO 8536-15
Infusion equipment for medical use
Part 15: Light-resistant infusion devices for single use
Date: 2023-06
ISO 80601-2-72:2023
Medical Electrical Equipment
Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
Date: 2023-06
ISO 41064:2023
Health informatics
Standard communication protocol — Computer-assisted electrocardiography
Date: 2023-06
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