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EN ISO 13408-2:2018/prA1:2025 Public enquiry
Comment end date 2025-12-30
Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAmd1:2025)
ISO/DIS 24884 Public enquiry
Comment end date 2025-12-20
Electronic Instructions for Use for In Vitro Diagnostic Medical Devices — Minimum required information and means of delivery
prEN ISO 8536-5 Public enquiry
Comment end date 2025-12-18
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO/DIS 8536-5:2025)

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

prEN IEC 63524:2025 Public enquiry
Comment end date 2025-12-10
Artificial Intelligence enabled Medical Devices - Computer assisted analysis software for pulmonary images - Algorithm performance test methods
prEN 18178-5 Public enquiry
Comment end date 2025-12-09
Respiratory infection prevention devices for self- and third-party protection - Part 5: Classification

This document specifies the classification for respiratory infection prevention devices (RIPDs). RIPDs are intended to reduce the emission of infective agents from the user’s airways into the environment, and also reduce exposure to the user from inhalation of infective agents. RIPDs are intended for use by everybody regardless of facial morphology or ability.

EN 455-3:2023/prA1 Public enquiry
Comment end date 2025-12-02
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

EN ISO 80601-2-13:2022/prA1 Public enquiry
Comment end date 2025-11-25
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2022/DAM 1:2025)
prEN ISO 21762 Public enquiry
Comment end date 2025-11-25
Medical devices utilizing non-viable human materials - Risk management (ISO/DIS 21762:2025)

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

EN ISO 4135:2022/prA1 Public enquiry
Comment end date 2025-11-18
Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2025)
prEN ISO 11607-3 Public enquiry
Comment end date 2025-11-11
Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies. This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring. This document applies to both preformed sterile barrier systems and sterile barrier systems. This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management. This document is intended to be used prior to process validation. NOTE ISO 11607-2 provides requirements for process specification and process validation.

EN ISO 11608-3:2022/prA1:2025 Archived
Comment end date 2025-10-28
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/DAmd1:2025)

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