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New standards and standards projects from August 2022

DIN EN ISO 10079-1 (Normen), DIN EN ISO 10079-2 (Normen), DIN EN ISO 10079-3 (Normen)

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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