New Standards and Standards-Projects in September 2023

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 80601-2-74 (Standard)

Medical electrical equipment - Part 2-74

Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021); German version EN ISO 80601-2-74:2021; Corrigendum 1

Date: 2023-09

DIN EN ISO 14708-4 ; VDE 0750-20-4: (Standard)

Implants for surgery - Active implantable medical devices

Part 4: Implantable infusion pump systems

Date: 2023-09

ISO 10993-17 (Standard)

Biological evaluation of medical devices

Part 17: Toxicological risk assessment of medical device constituents - Amendment 1

Date: 2023-09

ISO 11199-2 CD AMD 1 (Project)

Assistive products for walking manipulated by both arms 

Requirements and test methods

Part 2: Rollators – Amendment 1

Date: 2023-09-26  

ISO/AWI 7206-02 (Project)

Implants for surgery - Partial and total hip joint prostheses

Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

Date: 2023-09-15  

ISO/AWI 7206-6 (Project)

Implants for surgery - Partial and total hip joint prostheses

Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components

Date: 2023-09-15  

DIN EN ISO 17664-2 (Draft)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices

Part 2: Non-critical medical devices (ISO 17664-2:2021);

Date: 2023-09     

ISO/FDIS 17665 (Draft)

Sterilization of health care products - Moist heat

Requirements for the development, validation and routine control of a sterilization process for medical devices

Date: 2023-09

DIN EN 17999 (Draft)

Accessible systems for living independently

Requirements and recommendations

Date: 2023-09  

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