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prEN ISO 10993-4 Public enquiry
Comment end date 2026-09-03
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2026)

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.

ISO/DIS 25459 Public enquiry
Comment end date 2026-08-09
In vitro diagnostic medical devices — Requirements for determining commutability of certified reference materials used as secondary calibrators or trueness controls
prEN IEC 80601-2-77:2026 Public enquiry
Comment end date 2026-08-07
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
prEN IEC 80601-2-78:2026 Public enquiry
Comment end date 2026-08-07
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
prEN IEC 60601-2-18:2026 Public enquiry
Comment end date 2026-08-07
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ISO/DIS 25608 Public enquiry
Comment end date 2026-07-25
Healthcare organization management — Smart hospitals — RTLS for portable devices
EN IEC 62083:2026/prA1:2026 New
Comment end date 2026-07-22
Amendment 1 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems
ISO/DIS 25268 New
Comment end date 2026-07-22
Guidelines for hospital internal logistics services using autonomous mobile robots for the delivery of pharmaceuticals
prEN ISO 11138-6 Archived
Comment end date 2026-07-21
Sterilization of health care products - Biological indicators - Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes (ISO/DIS 11138-6:2026)

This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing vaporized hydrogen peroxide as the sterilizing agent. NOTE 1 Requirements for validation and control of vaporized hydrogen peroxide sterilization processes are provided by ISO 22441 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for workplace safety.

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