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06.04.2022

New Standards and Standards Projects in March 2022

DIN EN ISO 80601-2-90 (Standard), ISO 7176-14 (Standard), ISO 10079-1 (Standard)

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 80601-2-90 (Standard)

Medical Electrical Equipment

Part 2-90: Particular requirements for the safety and essential performance of high-flow respiratory therapy equipment

Date: 2022-03

ISO 7176-14 (Standard)

Wheelchairs

Part 14: Drive and control systems for electric wheelchairs and scooters - Requirements and test methods

Date: 2022-03

ISO 10079-1 (Standard)

Medical Suction Devices

Part 1: Medical suction devices - Part 1: Electrically powered suction devices

Date: 2022-03

ISO 10079-2 (Standard)

Medical Suction Devices

Part 2: Hand-operated suction devices

Date: 2022-03

ISO 10079-3 (Standard)

Medical Suction Devices

Part 3: Vacuum or pressure source operated suction devices

Date: 2022-03

ISO 20126 (Standard)

Dentistry

Manual toothbrushes General requirements and test methods

Date: 2022-03

DIN EN ISO 9680 (Standard)

Dentistry

Treatment lamps

Date: 2022-03

DIN EN ISO 10535 (Standard)

Assistive products - Hoists for the transfer of persons

Requirements and test methods

Date: 2022-03

DIN EN ISO 80601-2-84 (Draft)

Medical Electrical Equipment

Part 2-84: Particular requirements for the safety, including essential performance, of emergency and transport ventilators

Date: 2022-03

DIN EN ISO 21649 (Draft)

Needle-free injection systems for medical use

Requirements and test methods

Date: 2022-03

ISO/FDIS 16628 (Draft)

Tracheobronchial tubes

Size designations and labeling

Date: 2022-03

DIN EN 455-2 rev (Project)

Medical gloves for single use

Part 2: Requirements and testing of physical properties

Date: 2022-03-30

DIN EN 10993-7 rev (Project)

Biological evaluation of medical devices

Part 7: Ethylene oxide sterilisation residue

Date: 2022-03-29

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