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New Standards and Standard-Projects from June

ISO 7405 (Norm) / ISO 21850-2 (Norm) / DIN EN ISO 15004-2 (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 7376 AMD 1 (Standard)

Anaesthetic and respiratory equipment  

Laryngoscopes for tracheal intubation – Amendment 1: Clarification of optical output and illumination requirements

Date: 2025-06

ISO 21850-2 (Standard)

Dentistry

Materials for dental instruments - Part 2: Polymers

Date: 2025-06

ISO 7405 (Standard)

Dentistry

Evaluation of biocompatibility of medical devices used in dentistry

Date: 2025-06

DIN EN ISO 15004-2 (Standard)

Ophthalmic Instruments 

Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2024); German version EN ISO 15004-2:2024

Date: 2025-06

DIN EN ISO 16571/A1 (Draft)

Systems for evacuation of plume generated by medical devices 

Amendment 1 (ISO 16571:2024/DAM 1:2025); German and English version EN ISO 16571:2024/prA1:2025

Date: 2025-06

DIN EN ISO 13504 (Draft)

Dentistry

General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504.2:2025); German and English version prEN ISO 13504:2025

Date: 2025-06

DIN EN ISO 18369-1 (Draft)

Ophthalmic optics 

Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO/DIS 18369-1:2025); German and English version prEN ISO 18369-1:2025

Date: 2025-06

ISO 5361 DAM 1 (Project)

Anaesthetic and Respiratory Equipment

Tracheal tubes and connectors - Amendment 1: Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions

Date: 2025-06-03

ISO/AWI 14457 (Project)

Dentistry

Handpieces and motors

Date: 2025-06-06

DIN EN JT012003 (Project)

Accessibility of non-digital information related to products and services

Date: 2025-06-10

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