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 15883-7 (Standard)
Washer-disinfectors
Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025); German version EN ISO 15883-7:2025
Date: 2025-08
DIN EN 14180 (Standard)
Sterilizers for medical purposes
Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2025
Date: 2025-08
ISO 6877 (Standard)
Dentistry
Endodontic obturating materials
Date: 2025-08
ISO 21254-1 (Standard)
Lasers and laser-related equipment
Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
Date: 2025-08
ISO 10993-12 AMD 1 (Standard)
Biological evaluation of medical devices
Part 12: Sample preparation and reference materials - Amendment 1
Date: 2025-08
ISO 18527-3 AMD 1 (Standard)
Eye and face protection for sports use
Part 3: Requirements and test methods for eyewear intended to be used for surface swimming - Amendment 1
Date: 2025-08
DIN EN ISO 10079-1/A1 (Draft)
Medical Suction Devices
Part 1: Electrically powered suction equipment - Amendment 1: Ingress of water (ISO 10079-1:2022/DAM 1:2025); German and English version EN ISO 10079-1:2022/prA1:2025
Date: 2025-08
DIN EN ISO 10328 (Draft)
Prosthetics
Structural testing of lower-limb prostheses - Requirements and test methods (ISO/DIS 10328:2025); German and English version prEN ISO 10328:2025
Date: 2025-08
DIN 13068 (Project)
Anaesthesia and respiratory equipment
Tracheostoma valves
Date: 2025-08-15
DIN EN ISO 81060-3 rev (Project)
Non-invasive sphygmomanometers
Part 3: Clinical testing of the continuous automated type
Date: 2025-08-04
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