New Standards and Standard Projects in April 2021

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:


ISO/CD 18562-4 (Project)

Biocompatibility evaluation of breathing gas pathways in healthcare applications
Part 4: Tests for leachables in condensate

Date: 2021-04-20

DIN EN ISO 10651-5 (Draft)

Lung ventilators for medical use

Particular requirements for basic safety and essential performance
Part 5: Gas-powered emergency resuscitator

Date: 2021-04

DIN EN ISO 5361 (Draft)

Anaesthetic and respiratory equipment

Tracheal tubes and connectors (ISO/DIS 5361:2021)

Date: 2021-04

DIN EN ISO 20126 (Draft)


Manual toothbrushes
General requirements and test methods (ISO/DIS 20126:2021)

Date: 2021-04

ISO 20417:2021

Medical devices

Information to be supplied by the manufacturer

Date: 2021-04

ISO 80601-2-87:2021

Medical electrical equipment

Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators

Date: 2021-04


Continue reading Standards and Standard Projects from March 2021.



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