New Standards and Standard Projects in July 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:



DIN EN ISO 80601-2-79 (Project, in German)

Medizinische elektrische Geräte

Teil 2-79: Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten zur Atemunterstützung von Patienten mit Atmungsbeeinträchtigungen

Date: 2021-07-27

DIN EN ISO 80601-2-55/A1 (Project, in German)

Medizinische elektrische Geräte

Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für Atemgase – Änderung A1

Date: 2021-07-27

DIN EN ISO 21549-5 (Project, in German)

Medizinische Informatik

Patientendaten auf Karten im Gesundheitswesen

Teil 5: Identifikationsdaten

Date: 2021-07-27

ISO/IEEE DIS 11073-40101 (Project)

Health informatics – Device interoperability

Part 40101: Foundational-Cybersecurity – Processes for vulnerability assessment

Date: 2021-07-26

IEC 80601-2-59 DAM 1 (Project)

Medizinische electrical equipment

Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening – Amendment 1

Date: 2021-07-16

ISO/TS 82304-2:2021

Health software

Part 2: Health and wellness apps — Quality and reliability

Date: 2021-07

ISO 80601-2-74:2021

Medical electrical equipment

Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Date: 2021-07

ISO 15883-5:2021


Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy

Date: 2021-07

ISO 17664-1:2021

Processing of health care products

Information to be provided by the medical device manufacturer for the processing of medical devices

Part 1: Critical and semi-critical medical devices

Date: 2021-07

ISO 15223-1:2021

Medical devices

Symbols to be used with information to be supplied by the manufacturer

Part 1: General requirements

Date: 2021-07


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