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prEN IEC 60601-2-44:2025 Viešoji apklausa

Komentavimo iki data 2026-01-23

Elektrinė medicinos įranga. 2-44 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami kompiuterinės tomografijos rentgeno įrangai (IEC 60601-2-44:2025)

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prEN 14885 Viešoji apklausa

Komentavimo iki data 2026-01-22

Cheminiai dezinfekantai ir antiseptikai. Cheminiams dezinfekantams ir antiseptikams skirtų Europos standartų taikymas

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.

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EN IEC 60601-2-28:2019/prA1:2025 Viešoji apklausa

Komentavimo iki data 2026-01-14

Elektrinė medicinos įranga. 2-28 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami medicininės diagnostikos rentgeno vamzdžių sąrankoms

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EN ISO 13408-2:2018/prA1:2025 Viešoji apklausa

Komentavimo iki data 2025-12-30

Sveikatos priežiūros gaminių aseptinis apdorojimas. 2 dalis. Sterilizacinis filtravimas. 1 keitinys (ISO 13408-2:2018/DAmd1:2025)

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ISO/DIS 24884 Viešoji apklausa

Komentavimo iki data 2025-12-20

Diagnostikos in vitro medicinos priemonių naudojimo elektroninės instrukcijos. Minimali reikalaujama informacija ir pateikimo būdai

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prEN ISO 8536-5 Viešoji apklausa

Komentavimo iki data 2025-12-18

Medicinoje naudojama infuzijos įranga. 5 dalis. Vienkartinės biuretinės savitakio tiekimo infuzijos sistemos (ISO 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.

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prEN IEC 63524:2025 Viešoji apklausa

Komentavimo iki data 2025-12-10

Dirbtinį intelektą naudojančios medicinos priemonės. Plaučių vaizdų kompiuterinės analizės programinė įranga. Algoritmų efektyvumo testavimo metodai

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prEN 18178-5 Viešoji apklausa

Komentavimo iki data 2025-12-09

Apsaugos nuo kvėpavimo takų infekcijų priemonės, skirtos dėvinčiajam ir aplinkiniams asmenims apsaugoti. 5 dalis. Klasifikavimas

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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EN 455-3:2023/prA1 Viešoji apklausa

Komentavimo iki data 2025-12-02

Vienkartinės medicininės pirštinės. 3 dalis. Biologinio įvertinimo reikalavimai ir bandymai

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

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prEN ISO 21762 Archyvuotas

Komentavimo iki data 2025-11-25

Medicinos priemonės, kuriose naudojamos negyvybingos iš žmogaus gautos medžiagos. Rizikos valdymas (ISO/DIS 21762:2025)

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

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