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 13408-1 (Standard)
Aseptic processing of health care products
Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024
Date: 2024-09
DIN EN IEC 80601-2-77:2024-09 (Standard)
Medical Electrical Equipment
Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019 + AMD1:2023); German version EN IEC 80601-2-77:2021 + A1:2023
Date: 2024-09
DIN EN 556-1 (Standard)
Sterilization of medical devices
Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024
Date: 2024-09
DIN EN ISO 15098 (Standard)
Dentistry
Dental tweezers (ISO 15098:2024); German version EN ISO 15098:2024 2024-09
Date: 2024-09
DIN EN ISO 7376/A1 (Standard-Draft)
Anaesthetic and Respiratory Equipment
Laryngoscopes for tracheal intubation - Amendment 1: Clarification about optical output and illumination requirements (ISO 7376:2020/DAM 1:2024); German and English version EN ISO 7376:2020/prA1:2024
Date: 2024-09
DIN EN ISO 10993-17/A1 (Standard-Draft)
Biological evaluation of medical devices
Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAM 1:2024); German and English version EN ISO 10993-17:2023/prA1:2024
Date: 2024-09
DIN ISO 9211-2 (Standard-Draft)
Optics and photonics - Optical coatings
Part 2: Optical properties (ISO 9211-2:2024); Text in German and English
Date: 2024-09
DIN EN ISO 26782 rev (Project)
Anaesthesia and respiratory equipment
Spirometers intended for the measurement of time forced expired volumes in humans
Date: 2024-09-05
IEC 60601-2-40 Pre-release version (Project)
Medical Electrical Equipment
Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Date: 2024-09-06
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