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New Standards and Standards Projects in April

DIN EN ISO 17664-2 (Norm), ISO/AWI 23494-1 (Project), DIN 75078-1 (Project)

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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