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New Standards and Standards Projects in June 2023

DIN EN ISO 21649 (Norm), ISO 11737-3 (Norm), ISO 80601-2-72 (Norm)

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 21649 (Standard)

Needle-free injection systems for medical use

Requirements and test methods

Date: 2023-06

ISO 11737-3 (Standard)

Sterilization of health care products
– Microbiological methods

Part 3: Testing of bacterial endotoxins

Date: 2023-06

ISO 80601-2-72 (Standard)

Medical Electrical Equipment

Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

Date: 2023-06

ISO 24072 (Standard)

Aerosol bacterial retention test method for air-inlet filter on administration devices

Date: 2023-06

DIN EN ISO 8536-15 (Standard)

Infusion equipment for medical use

Part 15: Light-protective infusion sets for single use

Date: 2023-06

ISO 80601-2-72:2023 (Norm (English Only)

Medical Electrical Equipment

Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

Date: 2023-06

ISO 41064:2023 (Norm) (English Only)

Health informatics — Standard communication protocol

Computer-assisted electrocardiography

Date: 2023-06

DIN EN ISO 80601-2-79 (Draft)

Medical Electrical Equipment

Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

Date: 2023-06

DIN EN ISO 6872 (Draft)

Dentistry

Ceramic materials

Date: 2023-06

DIN EN ISO 80601-2-74 Berichtigung 1 (Project)

Medical Electrical Equipment

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

Date: 2023-06

DIN EN ISO 80601-2-70 rev (Projekt)

Medical Electrical Equipment

Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

Date: 2023-06

DIN EN ISO 80601-2-69 rev (Projekt)

Medical Electrical Equipment

Part 2-69: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

Date: 2023-06

DIN EN ISO 80601-2-67 rev (Project)

Medical Electrical Equipment

Part 2-67: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

Date: 2023-06

DIN EN ISO 7376/A1 (Project) 

Anaesthetic and Respiratory Equipment

Laryngoscopes for tracheal intubation – Amendment 1

Date: 2023-06

DIN EN ISO 10524-3 rev (Project)

Pressure regulators for use with medical gases

Part 3: Pressure regulators integrated with cylinder valves (VIPRs)

Date: 2023-06

DIN EN ISO 80601-2-74 rev (Project)

Medical Electrical Equipment

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

Date: 2023-06

DIN EN ISO 80601-2-90 rev (Project)

Medical Electrical Equipment

Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

Date: 2023-06

DIN CEN ISO/TS 17664-3 (Project)

Processing of health care products

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

Date: 2023-06

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