Standartų projektų sąrašas

prEN ISO 20126 Viešoji apklausa

Komentavimo iki data 2026-06-11

Odontologija. Rankiniai dantų šepetėliai. Bendrieji reikalavimai ir bandymo metodai (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.

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prEN ISO 29022 Viešoji apklausa

Komentavimo iki data 2026-06-02

Odontologija. Adhezija. Sanklijos stiprio šlyjant bandymas įtaisu su rantytu galu (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.

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ISO/DIS 24051-1 Viešoji apklausa

Komentavimo iki data 2026-05-27

Medicinos laboratorijos. 1 dalis. Bendrieji dirbtinio intelekto taikymo medicinos laboratorijose principai

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prEN ISO 7260 Viešoji apklausa

Komentavimo iki data 2026-05-26

Odontologija. Apsauginės filtravimo priemonės, naudojamos su elektriniais polimerizacijos aktyvinimo įtaisais (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.

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prEN ISO 3823 Viešoji apklausa

Komentavimo iki data 2026-05-26

Odontologija. Sukieji instrumentai. Plieniniai ir karbidiniai dantų grąžtai (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.

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prEN 13704 Viešoji apklausa

Komentavimo iki data 2026-05-26

Cheminiai dezinfekantai. Kiekybinis suspensijos tyrimas cheminių dezinfekantų, naudojamų maisto produktų gamyboje, pramonėje, buityje ir visuomeniniuose pastatuose, sporocidiniam aktyvumui įvertinti. Tyrimo metodas ir reikalavimai (2 fazė, 1 pakopa)

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.

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prEN ISO 8836 Viešoji apklausa

Komentavimo iki data 2026-05-12

Anestezijos ir kvėpavimo įranga. Kvėpavimo takų siurbimo kateteriai (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].

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prEN ISO 11737-1 Viešoji apklausa

Komentavimo iki data 2026-05-12

Sveikatos priežiūros produktų sterilizavimas. Mikrobiologiniai metodai. 1 dalis. Ant produktų esančių mikroorganizmų populiacijos nustatymas (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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prEN ISO 3630-1 Viešoji apklausa

Komentavimo iki data 2026-04-30

Odontologija. Endodontiniai instrumentai. 1 dalis. Bendrieji reikalavimai (ISO/DIS 3630-1:2026)

This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

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prEN ISO 3843 Archyvuotas

Komentavimo iki data 2026-04-28

Odontologija. Odontologiniai tvirtikliai. Įdėjimo ir išėmimo jėgų matavimas (ISO/DIS 3843:2026)

This document specifies a test method for measuring the forces needed for the placement and removal of dental attachments (frictional retention elements of ball head-, snap-on, prefabricated telescopic and bar systems used for the attachment, support and stabilization of crowns and bridges, single attachments, removable partial dentures, complete dentures, and other superstructures on dental implant systems (including monopart implants)and, if not other justified, on natural teeth and root post copings). If not otherwise justified, this document can also be used for tests on custom-made or patient matched devices (e.g. laboratory manufactured). This test method is not applicable to retention devices for which normal placement and removal requires any off-axis rotation for the path of least resistance. This test method is not applicable to dental magnetic attachments, these are specified in ISO 13017.

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prEN ISO 10555-3 Archyvuotas

Komentavimo iki data 2026-04-23

Kraujagyslių kateteriai. Sterilūs ir vienkartiniai kateteriai. 3 dalis. Centrinių venų kateteriai (ISO 10555-3:2026)

ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.

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prEN ISO 10555-5 Archyvuotas

Komentavimo iki data 2026-04-23

Kraujagyslių kateteriai. Sterilūs ir vienkartiniai kateteriai. 5 dalis. Periferiniai kateteriai su vidine adata (ISO 10555-5:2026)

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.

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prEN IEC 60601-2-92:2026 Archyvuotas

Komentavimo iki data 2026-04-22

Elektrinė medicinos įranga. 2-92 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami su išorinės spinduliuotės įranga naudojamai magnetinio rezonanso nukreipiamai radioterapijos įrangai

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