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prEN ISO 26782 Viešoji apklausa

Komentavimo iki data 2026-12-12

Anestezijos ir kvėpavimo įranga. Spirometrai per tam tikrą laiko tarpą žmonių iškvepiamam tūriui matuoti (ISO/DIS 26782:2026)

ISO 26782:2009 specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg. ISO 26782:2009 applies to spirometers that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.

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prEN ISO 5359 Viešoji apklausa

Komentavimo iki data 2026-11-26

Anestezijos ir kvėpavimo įranga. Mažaslėgių žarnų sąrankos, skirtos medicininėms dujoms (ISO/DIS 5359:2026)

ISO 5359:2014 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools, and for use with vacuum. It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.Nor does it specify the intended uses of hose assemblies.

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prEN ISO 18082 Viešoji apklausa

Komentavimo iki data 2026-11-26

Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO/DIS 18082:2026)

ISO 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute. ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; use with vacuum.

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prEN ISO 15883-4 Viešoji apklausa

Komentavimo iki data 2026-11-26

Dezinfekavimo plautuvai. 4 dalis. Dezinfekavimo plautuvų, skirtų termolabiliesiems endoskopams chemiškai dezinfekuoti, reikalavimai ir bandymai (ISO/DIS 15883-4:2026)

This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5). The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector. NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

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prEN ISO 25379-2 Viešoji apklausa

Komentavimo iki data 2026-11-19

In vitro diagnostikai taikomos naujos kartos sekoskaitos (NGS) veiksmų eiga. 2 dalis. Žmogaus RNR tyrimas

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document is addressing in vitro diagnostic examinations including laboratory developed tests and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

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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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prEN ISO 9360-2 Viešoji apklausa

Komentavimo iki data 2026-10-24

Įkvepiamo oro šildymo ir drėkinimo įtaisai ir kvėpuojamąsias dujas tiekiančių kvėpavimo sistemų filtrai. 2 dalis. Drėgmės nuostolių matavimas (ISO/DIS 9360-2:2026)

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prEN ISO 11137-2 Archyvuotas

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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