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 18190 (Standard)
Anaesthetic and Respiratory Equipment
General requirements for airway devices and related equipment
Date: 2025-02
DIN EN ISO 18562-1 (Standard)
Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
Part 1: Evaluation and testing within a risk management process
Date: 2025-02
DIN EN ISO 18562-2 (Standard)
Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
Part 2: Tests for emissions of particulate matter
Date: 2025-02
DIN EN ISO 80601-2-79 (Standard)
Medical Electrical Equipment
Part 2-79: Particular requirements for the basic safety and essential performance of home ventilators for respiratory support of patients with respiratory impairment
Date: 2025-02
DIN EN ISO 7197 (Standard)
Neurosurgical Implants
Sterile, single-use hydrocephalus shunts
Date: 2025-02
IEC 60601-2-68:2025 RLV (Standard)
Medical Electrical Equipment
Part 2-68: Particular requirements for the basic safety and essential performance of X-ray based image-guided radiotherapy equipment
Date: 2025-02
DIN EN ISO 18777-1 (Draft)
Transportable Liquid Oxygen Systems for Medical Use
Part 1: Common requirements and particular requirements for base units
Date: 2025-02
DIN EN ISO 80601-2-70 (Draft)
Medical Electrical Equipment
Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
Date: 2025-02
DIN EN ISO 10079-1/A1 (Project)
Medical Suction Devices
Part 1: Electrically operated suction equipment – Amendment 1: Water ingress
Date: 2025-01
DIN EN ISO 13666 rev (Project)
Ophthalmic Optics - Spectacle Lenses - Vocabulary
Date: 2025-01
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