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EN ISO 16571:2024/prA1 Public enquiry
Comment end date 2025-08-05
Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/DAM 1:2025)
prEN ISO 15747 Public enquiry
Comment end date 2025-07-17
Plastic containers for intravenous injections (ISO/DIS 15747:2025)

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

prEN ISO 3964-1 Public enquiry
Comment end date 2025-07-01
Dentistry - Coupling dimensions for handpiece connectors - Part 1: Mechanical properties (ISO/DIS 3964-1:2025)

This International Standard specifies the coupling between handpieces and motors connected to dental units. This International Standard specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light, and rotation energy.

prEN 1422 Public enquiry
Comment end date 2025-06-26
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

1.1 This document specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. 1.2 This document specifies requirements for ethylene oxide sterilizers (EO sterilizers) for: - the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices; - the equipment and controls of these sterilizers, needed for operation, control and monitoring of the sterilization processes; - the test equipment and test procedures used to verify the sterilizer performance specified by this document. 1.3 This document does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.

ISO/DIS 20364 Public enquiry
Comment end date 2025-06-25
Healthcare organization management — Guidance for healthcare organizations’ response to the surging diagnostic demands in a pandemic
prEN ISO 3630-8 Public enquiry
Comment end date 2025-06-24
Dentistry - Endodontic instruments - Part 8: Accuracy of electronic apex locator (ISO/DIS 3630-8:2025)

This part of ISO 3630 specifies requirements and test methods for the accuracy of electronic apex locators that are used to determine the apical foramen (‘apex’ in this document) location during endodontic treatment. Integrated types of electronic apex locators are excluded from this standard.

prEN ISO/IEEE 11073-10103 Public enquiry
Comment end date 2025-06-17
Health informatics - Device interoperability - Part 10103: Nomenclature - Implantable device, cardiac (ISO/IEEE FDIS 11073-10103:2025)

The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system.

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