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 17664-2 (Norm)
Information to be provided by the medical device manufacturer for the processing of medical devices
Part 2: Non-critical medical devices
Date: 2024-04
ISO/AWI 23494-1 (Project)
Biotechnology - Provenance information model for biological material and data
Part 1: Design concepts and general requirements
Date: 2024-04
DIN EN ISO 15747 rev (Project)
Plastic containers for intravenous injections
Date: 2024-04
DIN 75078-1 (Project)
Motor vehicles for the transport of persons with mobility impairments (KMP) - Terms, requirements, testing
Part 1: Vehicle characteristics and equipment
Date: 2024-04
DIN 75078-2 (Project)
Motor vehicles for the transport of persons with mobility impairments (KMP) - Terms, requirements, testing
Part 2: Restraint systems, with CD-ROM
Date: 2024-04
ISO/CD 11138-6 (Project)
Sterilization of health care products - Biological indicators
Part 6: Biological indicators for hydrogen peroxide sterilization processes
Date: 2024-04
DIN EN ISO 11135 (Draft)
Sterilization of health care products - Ethylene oxide
Requirements for the development, validation and routine control of a sterilization process for medical devices
Date: 2024-04
DIN EN ISO 18777-1 (Draft)
Transportable Liquid Oxygen Systems for Medical Use
Part 1: Common requirements and particular requirements for base units
Date: 2024-04
DIN EN ISO 18777-2 (Draft)
Transportable Liquid Oxygen Systems for Medical Use
Part 2: Portable units
Date: 2024-04
DIN EN ISO 11199-2/A1 (Draft)
Assistive products for walking manipulated by both arms - Requirements and test methods
Part 2: Rollators - Amendment 1: Eliminate brake requirements in 6.5 Structure requirements
Date: 2024-04
DIN EN ISO 7405 (Draft)
Dentistry
Evaluation of biocompatibility of medical devices used in dentistry
Date: 2024-04
DIN EN ISO 10993-4/A1 (Draft)
Biological evaluation of medical devices
Part 4: Selection of tests for interactions with blood
Date: 2024-04
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