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New Standards and Standards-Projects in July 2022

ISO 21856 (Norm), ISO 23368 (Norm), DIN EN 60601-2-65; VDE 0750-2-65:2022-07 (Norm)

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:

ISO 21856 (Standard)

Technical aids for people with a disability

General requirements and test methods

Date: 2022-07

ISO 23368 (Standard)

Anaesthesia and respiratory equipment - Nasal cannulas for respiratory therapy

Date: 2022-07

DIN EN 60601-2-65; VDE 0750-2-65:2022-07 (Standard)

Medical Electrical Equipment

Part 2-65: Particular requirements for the safety, including essential performance, of intraoral dental X-ray equipment

Date: 2022-07

ISO 11228-2 AMD 1 (Standard)

Ergonomics - Manual handling

Part 2: Push and pull; Amendment 1

Date: 2022-07

DIN EN ISO 13972 (Standard)

Medical Informatics - Clinical Information Model

Characteristics, structures and requirements

Date: 2022-07

DIN EN ISO 11073-40102 (Standard)

Medical Informatics - Device Interoperability

Part 40102: Basics - Cybersecurity - Ways to limit damage

 Date: 2022-07

DIN EN ISO 11073-40101 (Standard)

Medical Informatics - Device Interoperability

Part 40101: Fundamentals - Cybersecurity - Vulnerability analysis process

Date: 2022-07

DIN EN IEC 60601-2-83/A1; VDE 0750-2-83/A1:2022-07 (Draft)

Medical Electrical Equipment

Part 2-83: Particular requirements for the safety, including essential performance, of home phototherapy equipment

Date: 2022-07

ISO/CD 13404-1 (Project)

Prosthetics and Orthotics

Classification and description of external orthoses and orthotic components

Date: 2022-07-01

ISO/CD TS 16840-14 (Project)

Sitting in a wheelchair

Part 14: Vocabulary and concepts related to dealing with external forces to maintain tissue integrity

Date: 2022-07-08

SO/AWI 23328-2 (Project)

Filters for breathing systems for use in anaesthesia and ventilation

Part 2: Non-filtration aspects

Date: 2022-07-14

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