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 10079-1 (Standard)
Medical Suction Devices
Part 1: Electrically operated suction devices
Date: 2022-08
DIN EN ISO 10079-2 (Standard)
Medical Suction Devices
Part 2: Hand-operated suction devices
Date: 2022-08
DIN EN ISO 10079-3 (Standard)
Medical Suction Devices
Part 3: Vacuum or pressure source operated suction devices
Date: 2022-08
DIN EN ISO 23372 (Standard)
Anaesthetic and Respiratory Equipment
Air admixing devices
Date: 2022-08
DIN EN ISO 23371 (Standard)
Anaesthetic and Respiratory Equipment
Cuff pressure indicators and cuff pressure regulating devices
Date: 2022-08
DIN EN 60601-2-63; VDE 0750-2-63:2022-08 (Standard)
Medical Electrical Equipment
Part 2-63: Particular requirements for the safety, including essential performance, of extraoral dental X-ray equipment
Date: 2022-08
DIN EN IEC 60601-2-83/A11; VDE 0750-2-83/A11:2022-08 (Standards)
Medical Electrical Equipment
Part 2-83: Particular requirements for the safety, including essential performance, of home phototherapy equipment
Date: 2022-08
DIN EN IEC 60601-2-76/A1; VDE 0750-2-76/A1:2022-08 (Draft)
Medical Electrical Equipment
Part 2-76: Particular requirements for the safety, including essential performance, of ionised gas coagulation equipment
Date: 2022-08
DIN EN IEC 80601-2-78/A1; VDE 0750-2-78/A1:2022-08 (Draft)
Medical Electrical Equipment
Part 2-78: Particular requirements for the safety, including essential performance, of medical robots for rehabilitation, assessment, compensation or palliation
Date: 2022-08
DIN EN ISO 10451 rev (Project)
Dentistry
Contents of the technical documentation for dental implant systems
Date: 2022-08-26
ISO/AWI 15223-2 (Project)
Medical devices
Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validation
Date: 2022-08-26
DIN EN ISO 9360-2 rev (Project)
Anaesthetic and Respiratory Equipment
Heat and moisture exchangers for humidification of respiratory gases in humans
Part 2: Heat and moisture exchangers for use in tracheostomised patients with minimum stroke volumes of 250 ml
Date: 2022-08-12
DIN EN ISO 23328-2 rev (Project)
Filters for breathing systems for use in anaesthesia and ventilation
Part 2: Aspects not related to filtration
Date: 2022-08-12
ISO 16840-2 CD AMD 1 (Project)
Wheelchair seating
Part 2: Determination of physical and mechanical properties of seat cushions intended for fabric integrity management - Amendment 1
Date: 2022-08-05
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