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 23368 (standard)
Anaesthetic and Respiratory Equipment
Nasal cannulae for respiratory therapy
Date: 2022-11
DIN EN 60601-1; VDE 0750-1:2022-11 (standard)
Medical Electrical Equipment
Part 1: General requirements for safety including essential performance characteristics
Date: 2022-11
DIN EN IEC 60601-2-21; VDE 0750-2-21:2022-11 (standard)
Medical Electrical Equipment
Part 2-21: Particular requirements for the safety, including essential performance, of radiant warmers for infants
Date: 2022-11
ISO 10993-2 (standard)
Biological evaluation of medical devices
Part 2: Animal welfare regulations
Date: 2022-11
DIN EN IEC 60601-2-43; VDE 0750-2-43:2022-11 (Draft)
Medical Electrical Equipment
Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
Date: 2022-11
DIN EN IEC 60601-2-39; VDE 0750-2-39:2022-11 (Draft)
Medical Electrical Equipment
Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment (IEC 62D/1913/CD:2021)
Date: 2022-11
DIN EN IEC 80601-2-26/A1; VDE 0750-2-26/A1:2022-11 (Draft)
Medical Electrical Equipment
Part 2-26: Particular requirements for the safety, including essential performance, of electroencephalographs
Date: 2022-11
DIN EN ISO 11608-5 (Draft)
Cannula-based injection systems for medical use - Requirements and test methods
Part 5: Automated functions
Date: 2022-11
ISO/CD 17256 (Project)
Anaesthetic and respiratory equipment
Respiratory therapy tubing and connectors
Date: 2022-11-18
ISO/CD 19211 (Project)
Anaesthetic and respiratory equipment
Fire-activated oxygen shut-off devices for use during oxygen therapy
Date: 2022-11-18
ISO/CD 18777-1 (Project)
Liquid oxygen systems for medical applications - Special requirements
Part 1: Base unit
Date: 2022-11-18
ISO/CD 18777-2 (Project)
Liquid oxygen systems for medical applications - Special requirements
Part 2: Portable unit
Date: 2022-11-18
ISO/AWI 18969 (Project)
Clinical evaluation of medical devices
Date: 2022-11-17
DIN CEN ISO/TS 11137-4 (Project)
Sterilization of health care products
Radiation - Guide to process control
Date: 2022-11-24
DIN EN ISO 13004 (Project)
Sterilization of health care products
Radiation - confirmation of the selected sterilisation dose: VDmaxSD method
Date: 2022-11-21
DIN EN ISO 17664-2 (Project)
Reprocessing of healthcare products - Information to be provided by the medical device manufacturer for the reprocessing of medical devices
Part 2: Non-critical medical devices (ISO 17664-2:2021);
Date: 2022-11-17
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