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 11334-4 (Standard)
Assistive products for walking, manipulated by one arm
Requirements and test methods - Part 4: Walking sticks with three or more legs (ISO 11334-4:2024); German version EN ISO 11334-4:2024
Date: 2025-01
ISO 7711-1 AMD 1 (Standard)
Dentistry
Diamond rotary instruments - Part 1: General requirements - Amendment 1
Date: 2025-01
ISO 8548-3 (Standard)
Prosthetics and Orthotics
Limb deficiencies - Part 3: Method of describing the residual limb after upper limb amputation
Date: 2025-01
IEC 60601-2-16:2025 RLV (Norm) (English Only)
Medical electrical equipment
Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Date: 2025-01
DIN EN ISO 15621 (Draft)
Absorbent incontinence products for urine and/or faeces
General guidelines on evaluation (ISO/DIS 15621:2024); German and English version prEN ISO 15621:2024
Date: 2025-01
DIN EN ISO 17510 (Draft)
Medical devices
Sleep apnoea breathing therapy - Masks and application accessories (ISO/DIS 17510:2024); German and English version prEN ISO 17510:2024
Date: 2025-01
DIN EN ISO 12487 (Draft)
Medical electrical equipment
Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024); German and English version prEN ISO 12487:2024
Date: 2025-01
ISO/AWI TS 23485 (Projekt) (English Only)
Medical electrical equipment
Quality management systems - Guideline for the application of ISO 13485:2016
Date: 2025-01-10
DIN EN ISO 6872 rev (Project)
Dentistry
Ceramic materials
Date: 2025-01-07
DIN EN ISO 15752 rev (Project)
Ophthalmic Instruments
Endoilluminators - Fundamental requirements and test methods for optical radiation safety
Date: 2025-01-21
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