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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.

prEN IEC 60731:2026 Public enquiry
Comment end date 2026-06-17
Medical electrical equipment - Dosimeters with ionization chambers or solid-state detectors as used in radiotherapy
prEN ISO 20126 Public enquiry
Comment end date 2026-06-11
Dentistry - Manual toothbrushes - General requirements and test methods (ISO/DIS 20126:2026)

This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer. This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials. In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.

prEN ISO 29022 Public enquiry
Comment end date 2026-06-02
Dentistry - Adhesion - Notched-edge shear bond strength test (ISO/DIS 29022:2026)

ISO 29022:2013 specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.

ISO/DIS 24051-1 Public enquiry
Comment end date 2026-05-27
Medical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratories
prEN ISO 7260 Public enquiry
Comment end date 2026-05-26
Dentistry - Protective filtering devices intended for use with powered polymerization activators (ISO/DIS 7260:2026)

This document specifies requirements, test methods, and labeling for protective filtering devices intended for protection against retinal blue light exposure from powered polymerization activators in the scope of ISO 10650:2018, i.e., powered polymerization activators using quartz-tungsten halogen lamps or light emitting diodes (LED) to activate polymerization. This document does not apply to protective filtering devices for lasers or plasma arc devices.

prEN ISO 3823 Public enquiry
Comment end date 2026-05-26
Dentistry - Rotary instruments - Steel and carbide dental burs (ISO/DIS 3823:2026)

This document specifies the general requirements and test methods for steel and carbide rotary instruments used in dentistry, including designation, colour code and a quality control for these instruments. It applies to all types of steel and carbide rotary instruments independent of type and shape.

prEN 13704 Public enquiry
Comment end date 2026-05-26
Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)

This document specifies a test method (phase 2/step 1) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water and that are used in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. This European Standard applies at least to the following: a) processing, distribution and retailing of: 1) food of animal origin: - milk and milk products; - meat and meat products; - fish, seafood, and related products; - eggs and egg products; - animal feeds; - etc.; 2) food of vegetable origin: - beverages; - fruits, vegetables and derivatives (including sugar, distillery, etc.); - flour, milling and baking; - animal feeds; - etc.; b) institutional and domestic areas: - catering establishments; - public areas; - public transports; - schools; - nurseries; - shops; - sports rooms; - waste containers (bins, etc.); - hotels; - dwellings; - clinically non sensitive areas of hospitals; - offices; - etc.; c) other industrial areas: - packaging material; - biotechnology (yeast, proteins, enzymes, etc.); - pharmaceutical; - cosmetics and toiletries; - textiles; - space industry, computer industry; - etc. Using this European Standard, it is not possible to determine the sporicidal activity of undiluted product as some dilution is always produced by adding the inoculum and interfering substance. Products can only be tested at a concentration of 80 % or less. NOTE The method described is intended to determine the activity of commercial formulations or active substances on spores in the conditions in which they are used.

prEN ISO 8836 Public enquiry
Comment end date 2026-05-12
Anaesthetic and respiratory equipment - Suction catheters for use in the respiratory tract (ISO/DIS 8836:2026)

This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

prEN ISO 11737-1 Public enquiry
Comment end date 2026-05-12
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2026)

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

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