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prEN ISO 7864 Public enquiry
Comment end date 2026-01-29
Sterile hypodermic needles for single use - Requirements and test methods (ISO/DIS 7864:2025)

ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

prEN ISO 9626 Public enquiry
Comment end date 2026-01-29
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO/DIS 9626:2025)

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device. It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge). It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

prEN IEC 60601-2-44:2025 Public enquiry
Comment end date 2026-01-23
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
prEN 14885 Public enquiry
Comment end date 2026-01-22
Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics

This document specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this document. This document also specifies terms and definitions which are used in European Standards. It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages). It is intended to: a) enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product; b) enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product; c) assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market. It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas. In the area of human medicine (Working Group 1, i.e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care — in hospitals, in community medical facilities, dental institutions and medical laboratories for analyses and research, — in clinics of schools, of kindergartens and of nursing homes, — and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient. In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals and veterinary laboratories for analyses and research. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry. In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries. This document is also applicable to active substances and products under development for which no area of application has yet been specified. This document will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards are to be used, even if they are not yet mentioned in EN 14885. This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.

EN IEC 60601-2-28:2019/prA1:2025 Public enquiry
Comment end date 2026-01-14
Amendment 1 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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 New
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 Archived
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.

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