Standartų projektų sąrašas

prEN IEC 60601-2-54:2026 Viešoji apklausa

Komentavimo iki data 2026-11-06

Elektrinė medicinos įranga. 2-54 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami radiografijoje ir radioskopijoje naudojamai rentgeno įrangai (IEC 60601-2-54:2026)

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EN ISO 5367:2023/prA1:2026 Viešoji apklausa

Komentavimo iki data 2026-10-24

Anestezijos ir kvėpavimo įranga. Kvėpavimo priemonių rinkiniai ir jungtys. 1 keitinys. Papildomi reikalavimai, keliami papildomų priemonių prijungimo jungtims (ISO 5367:2023/DAmd1:2026)

Additional requirements for connectors for accessory access connection port

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prEN ISO 9360-1 Viešoji apklausa

Komentavimo iki data 2026-10-24

Įkvepiamo oro šildymo ir drėkinimo įtaisai ir kvėpuojamąsias dujas tiekiančių kvėpavimo sistemų filtrai. 1 dalis. Bendrieji reikalavimai (ISO/DIS 9360-1:2026)

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EN ISO 15002:2024/prA1 Viešoji apklausa

Komentavimo iki data 2026-10-17

Prie medicininių dujų tiekimo sistemų jungiami srauto kontrolės įtaisai. 1 keitinys (ISO 15002:2023/DAM 1:2026)

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prEN ISO 11137-2 Viešoji apklausa

Komentavimo iki data 2026-10-15

Sveikatos priežiūros gaminių sterilizavimas. Spinduliuotė. 2 dalis. Sterilizavimo dozės nustatymas (ISO/DIS 11137-2:2026)

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

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prEN 18368 Viešoji apklausa

Komentavimo iki data 2026-10-10

Cheminiai dezinfekantai ir antiseptikai. Cheminiai dezinfekantai ir antiseptikai. Kiekybinis tyrimo metodas virucidiniam aktyvumui įvertinti, neakytus paviršius mechaniškai valant medicinos srityje naudojamomis servetėlėmis (4 plotelių tyrimas). Tyrimo metodas ir reikalavimai (2 fazė, 2 pakopa)

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water. This document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping – regardless if they are covered by the Medical Device Regulation [1] or not. Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods. This document is applicable for four methods of application of products for wiping and/or mopping: a) soaking any non-specified wipe or mop with product; b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop; c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation; d) pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops. In all types of application the water control has to be conducted with the standard wipe (5.3.2.17 a), because it is process or method control. The contact time for the water control is no longer than 5 min. This document does not apply to products that are sprayed on or used for flooding of surfaces, without wiping or mopping during the contact time. In this case, the methods of phase 2/ step 2 without mechanical action apply. The test-surface (5.3.2.16) was selected as a standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface. This document is applicable to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: — in hospitals, in community medical facilities and in dental institutions; — in clinics of schools, of kindergartens and of nursing homes; and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients. NOTE This method corresponds to a phase 2, step 2 test. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

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prEN ISO 19223-1 Viešoji apklausa

Komentavimo iki data 2026-10-10

Plaučių ventiliacijos aparatai ir susijusi įranga. Aiškinamasis žodynas ir semantika. 1 dalis. Plaučių ventiliacijos aparatai (ISO/DIS 19223-1:2026)

This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable — in lung ventilator and breathing-therapy device standards, — in health informatics standards, — for labelling on medical electrical equipment and medical electrical systems, — in medical electrical equipment and medical electrical system instructions for use and accompanying documents, — for medical electrical equipment and medical electrical systems interoperability, and — in electronic health records. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system. NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems. This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.

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prEN ISO 7396-1 Viešoji apklausa

Komentavimo iki data 2026-09-12

Medicininių dujų vamzdynų sistemos. 1 dalis. Suslėgtų medicininių dujų ir vakuumo vamzdynų sistemos (ISO/FDIS 7396-1:2026)

ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following: - oxygen; - nitrous oxide; - medical air; - carbon dioxide; - oxygen/nitrous oxide mixtures (see Note 1); - helium/oxygen mixtures; - (*) oxygen 93; - gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above; - air for driving surgical tools; - nitrogen for driving surgical tools; - vacuum. NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems. NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396‑2. This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems. This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to: a) acute care healthcare facilities; b) internal patient continuing care healthcare facilities; c) long-term care facilities; d) community-based providers; e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices). NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities. ISO 7396-1:2016 applies to the following different types of oxygen supply systems: - supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%; - supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%; NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%. ISO 7396-1:2016 also applies to: - extensions of existing pipeline distribution systems; - modifications of existing pipeline distribution systems; - modifications or replacement of supply systems or sources of supply. Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396. NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69. (*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients. ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry. ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.

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EN ISO 15195:2019/prA1 Viešoji apklausa

Komentavimo iki data 2026-09-26

Laboratorinė medicina. Pamatines matavimo procedūras taikančių kalibravimo laboratorijų kompetencijos reikalavimai. 1 keitinys (ISO 15195:2018/DAM 1:2026)

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ISO 15195:2018/DAmd 1 Viešoji apklausa

Komentavimo iki data 2026-09-24

Laboratorinė medicina. Pamatines matavimo procedūras taikančių kalibravimo laboratorijų kompetencijos reikalavimai. 1 keitinys

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prEN IEC 60601-2-36:2026 Viešoji apklausa

Komentavimo iki data 2026-09-16

Elektrinė medicinos įranga. 2-36 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami ekstrakorporinės litotripsijos įrangai

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prEN IEC 80601-2-86:2026 Viešoji apklausa

Komentavimo iki data 2026-09-16

Elektrinė medicinos įranga. 2-86 dalis. Ypatingieji būtinosios saugos ir esminių eksploatacinių charakteristikų reikalavimai, keliami elektrokardiografams, įskaitant diagnostinę įrangą, stebėsenos įrangą, ambulatorinę įrangą, elektrodus, kabelius ir laidus

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