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EN ISO 1942:2020/prA1 Naujas

Komentavimo iki data 2025-06-03

Odontologija. Aiškinamasis žodynas. 1 keitinys. Bandymų tipų apibrėžtys, naudojamos rengiant standartus (ISO 1942:2020/DAM 1:2025)

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EN IEC 80601-2-60:2020/prA1:2025 Naujas

Komentavimo iki data 2025-05-28

Elektrinė medicinos įranga. 2-60 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami odontologijos įrangai

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prEN ISO 22532 Viešoji apklausa

Komentavimo iki data 2025-05-20

Sveikatos informatika. Vaistų identifikavimas. Vaistų identifikavimo standartų pagrindinių terminų aiškinamasis žodynas (terminai ir apibrėžtys) (ISO/DIS 22532:2025)

This standard lists the terms and definitions to be used in the IDMP (Identification of medicinal products) standards and technical specifications, when terms and definitions as to be used in more than one of these standards.

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prEN ISO 10524-3 Viešoji apklausa

Komentavimo iki data 2025-05-20

Medicininių dujų slėgio reguliatoriai. 3 dalis. Slėgio reguliatoriai, įmontuoti į balionų čiaupus (ISO/DIS 10524-3:2025)

This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools. Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures. This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications. VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).

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prEN ISO 10477 Viešoji apklausa

Komentavimo iki data 2025-05-15

Odontologija. Polimerinės vainikėlių ir laminačių medžiagos (ISO/DIS 10477:2025)

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prEN ISO 16791 Viešoji apklausa

Komentavimo iki data 2025-05-13

Sveikatos informatika. Reikalavimai, keliami vaistų pakuočių identifikatorių tarptautiniam mašininio nuskaitymo kodavimui (ISO/DIS 16791:2025)

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

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prEN ISO 10873 Viešoji apklausa

Komentavimo iki data 2025-05-13

Odontologija. Dantų protezų klijai (ISO/DIS 10873:2025)

This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.

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EN ISO 7551:2023/prA1 Viešoji apklausa

Komentavimo iki data 2025-05-06

Odontologija. Endodontiniai absorbciniai kaiščiai. 1 keitinys (ISO 7551:2023/DAM 1:2025)

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prEN ISO 10650 Viešoji apklausa

Komentavimo iki data 2025-04-29

Odontologija. Elektriniai polimerizacijos aktyvinimo įtaisai (ISO/DIS 10650:2025)

This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard. This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

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EN ISO 80601-2-13:2022/prA1:2025 Viešoji apklausa

Komentavimo iki data 2025-04-22

Elektrinė medicinos įranga. 2-13 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami anestezijos darbo stotims. 1 keitinys (ISO 80601-2-13:2022/DAmd1:2025)

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prEN ISO 5832-2 Viešoji apklausa

Komentavimo iki data 2025-04-22

Chirurginiai implantai. Metalinės medžiagos. 2 dalis. Nelegiruotasis titanas (ISO/DIS 5832-2:2025)

This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in this document.

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prEN IEC 80601-2-30:2025 Viešoji apklausa

Komentavimo iki data 2025-04-16

Elektrinė medicinos įranga. 2-30 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami automatiniams netiesioginiams kraujospūdžio matuokliams

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prEN ISO 15883-6 Viešoji apklausa

Komentavimo iki data 2025-04-15

Dezinfekavimo plautuvai. 6 dalis. Dezinfekavimo plautuvų, skirtų neinvazinėms medicinos priemonėms ir sveikatos priežiūros įrangai termiškai dezinfekuoti, reikalavimai ir bandymai (ISO/DIS 15883-6:2025)

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

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prEN ISO 27799 Naujas

Komentavimo iki data 2025-03-27

Sveikatos informatika. Informacijos saugumo valdymas sveikatos priežiūros srityje, taikant ISO/IEC 27002 (ISO 27799:2025)

ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s). It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that International Standard. ISO 27799:2016 provides implementation guidance for the controls described in ISO/IEC 27002 and supplements them where necessary, so that they can be effectively used for managing health information security. By implementing ISO 27799:2016, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is appropriate to their organization's circumstances and that will maintain the confidentiality, integrity and availability of personal health information in their care. It applies to health information in all its aspects, whatever form the information takes (words and numbers, sound recordings, drawings, video, and medical images), whatever means are used to store it (printing or writing on paper or storage electronically), and whatever means are used to transmit it (by hand, through fax, over computer networks, or by post), as the information is always be appropriately protected. ISO 27799:2016 and ISO/IEC 27002 taken together define what is required in terms of information security in healthcare, they do not define how these requirements are to be met. That is to say, to the fullest extent possible, ISO 27799:2016 is technology-neutral. Neutrality with respect to implementing technologies is an important feature. Security technology is still undergoing rapid development and the pace of that change is now measured in months rather than years. By contrast, while subject to periodic review, International Standards are expected on the whole to remain valid for years. Just as importantly, technological neutrality leaves vendors and service providers free to suggest new or developing technologies that meet the necessary requirements that ISO 27799:2016 describes. As noted in the introduction, familiarity with ISO/IEC 27002 is indispensable to an understanding of ISO 27799:2016. The following areas of information security are outside the scope of ISO 27799:2016: a) methodologies and statistical tests for effective anonymization of personal health information; b) methodologies for pseudonymization of personal health information (see Bibliography for a brief description of a Technical Specification that deals specifically with this topic); c) network quality of service and methods for measuring availability of networks used for health informatics; d) data quality (as distinct from data integrity).

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