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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
prEN ISO 10993-11 Public enquiry
Comment end date 2026-07-23
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2026)

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

EN IEC 62083:2026/prA1:2026 Public enquiry
Comment end date 2026-07-22
Amendment 1 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems
ISO/DIS 25268 Public enquiry
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 Public enquiry
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.

ISO/DIS 23640 Public enquiry
Comment end date 2026-07-13
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
prEN ISO 23640 Public enquiry
Comment end date 2026-07-09
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO/DIS 23640:2026)

ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device. ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in: the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; the establishment of stability of the IVD reagent in use after the first opening of the primary container; the monitoring of stability of IVD reagents already placed on the market; the verification of stability specifications after modifications of the IVD reagent that might affect stability.

prEN ISO 23402-2 Public enquiry
Comment end date 2026-06-30
Dentistry - Portable dental equipment for use in non‐permanent healthcare environments - Part 2: Portable dental units (ISO/DIS 23402-2:2026)
prEN ISO 20795-1 rev Public enquiry
Comment end date 2026-06-30
Dentistry - Base polymers - Part 1: Denture base polymers (ISO/DIS 20795-1:2026)

ISO 20795-1:2013 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore, it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. ISO 20795-1:2013 applies to denture base polymers such as those listed below: poly(acrylic acid esters); poly(substituted acrylic acid esters); poly(vinyl esters); polystyrene; rubber modified poly(methacrylic acid esters); polycarbonates; polysulfones; poly(dimethacrylic acid esters); polyacetals (polyoxymethylene); copolymers or mixtures of the polymers listed in 1 to 9.

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