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New standards and standards projects from November

ISO 17510 (Standard) / ISO 10993-1 (Standard) / ISO/AWI TS 26177 (Project)

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 17510 (Standard)

Medical Devices  

Sleep apnoea breathing therapy - Masks and application accessories

Date: 2025-11

DIN EN ISO 19211 (Standard)

Anaesthetic and Respiratory Equipment 

Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024); German version EN ISO 19211:2025

Date: 2025-11

DIN EN ISO 6877 (Standard)

Dentistry

Endodontic obturating materials (ISO 6877:2025); German version EN ISO 6877:2025

Date: 2025-11

DIN EN ISO 20127 (Standard)

Dentistry

Physical properties of powered toothbrushes (ISO 20127:2025); German version EN ISO 20127:2025

Date: 2025-11

ISO 10993-1 (Standard)

Biological evaluation of medical devices 

Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

Date: 2025-11

DIN EN ISO 13408-2/A1 (Draft)

Aseptic processing of health care products  

Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAM 1:2025); German and English version EN ISO 13408-2:2018/prA1:2025

Date: 2025-11

ISO/AWI 25992 (Project)

Single-use receptacles for human arterial blood specimen collection

Arterial blood gas collection needles

Date: 2025-11-12

ISO/AWI 21606 (Project)

Dentistry

Elastomeric auxiliaries for use in orthodontics

Date: 2025-11-05

ISO/AWI TS 26177 (Projekt) (English Only)

Biological evaluation of medical devices 

Guidance on risk estimation in the application of ISO 10993-1

Date: 2025-11-03

DIN 19414 (Project)

Dentistry

Terms related to membranes and barriers

Date: 2025-11-18


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