New Standards and Standards Projects in April 2023

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 61632 (Standard)

Surgical dressings – Cotton crepe bandages

Date: 2023-04

DIN EN ISO 10993-10 (Standard)

Biological evaluation of medical devices

Part 10: Tests for skin sensitization

Date: 2023-04

DIN EN ISO/IEEE 11073-10419 (Draft)

Health informatics – Personal health device communication

Part 10419: Device specialization – Insulin pump

Date: 2023-04

DIN EN 455-5 (Draft)

Medical gloves for single use

Part 5: Extractable chemical residues

Date: 2023-04

DIN 58953-6 (Draft)

Sterilization – Sterile supply

Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

Date: 2023-04

DIN EN 14180 (Draft)

Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing

Date: 2023-04

DIN EN ISO 80369-20 (Draft)

Small-bore connectors for liquids and gases in healthcare applications

Part 20: Common test methods

Date: 2023-04

DIN EN ISO 17117-1 (Draft)

Health informatics – Terminological resources

Part 1: Characteristics

Date: 2023-04

DIN EN ISO 10993-11 rev (Project)

Biological evaluation of medical devices

Part 11: Tests for systemic toxicity

Date: 2023-04

ISO/IEC AWI TR 18988 (Project)

Artificial intelligence – Application of AI technologies in health informatics

Date: 2023-04

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