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New Standards and Standard-Projects from June 2024

DIN EN ISO 11139 (Standard) / DIN EN ISO 8362-2 (Standard) / DIN ES ISO 5363 rev (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 11139 (Standard)

Sterilization of health care products

Changes in the vocabulary used in sterilization and related equipment and process standards.

Date: 2024-06

DIN EN ISO 8362-2 (Standard)

Injection containers and accessories

Part 2: Closures for injection vials

Date: 2024-06

DIN EN ISO 5364 rev (Project)

Anaesthetic and Respiratory Equipment

Oropharyngeal airways

Date: 2024-06

ISO/CD 16840-6 (Project)

Wheelchair seating

Simulated use and determination of the changes in properties of seat cushions

Date: 2024-06

DIN EN 455-3/A1 (Project)

Medical gloves for single use

Part 3: Requirements and testing for biological evaluation

Date: 2024-06

DIN EN 00205399 (Project)

Respiratory infection prevention devices for self- and third-party protection

Part 1: Requirements and marking

Date: 2024-06

DIN EN 00205400 (Project)

Respiratory infection prevention devices for self- and third-party protection

Part 2: Test methods

Date: 2024-06

DIN EN ISO 5361 (Project)

Anaesthetic and Respiratory Equipment

Tracheal tubes and connecting pieces 

Date: 2024-06

DIN EN ISO 81060-2 rev (Project)

Non-invasive sphygmomanometers

Part 2: Clinical performance verification of intermittent automated measurement type

Date: 2024-06

DIN EN ISO 15223-1/ A1 (Draft)

Medical devices - Symbols to be used with information to be supplied by the manufacturer

Part 1: General Prerequisites – Amendment 1

Date: 2024-06

DIN EN ISO 10993-6 (Draft)

Biological evaluation of medical devices

Part 6: Tests for local effects after implantation

Date: 2024-06



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