Standartų projektų sąrašas

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 10555-3 Viešoji apklausa

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 Viešoji apklausa

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 Viešoji apklausa

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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prEN ISO 3826-4 Viešoji apklausa

Komentavimo iki data 2026-04-21

Žmogaus kraujui ir kraujo komponentams naudojamos plastikinės sulankstomos talpyklės. 4 dalis. Aferezės kraujo maišelių sistemos su įtaisytomis pagalbinėmis priemonėmis (ISO/DIS 3826-4:2026)

This document specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826. The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid. This document specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.

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prEN ISO 3826-3 Viešoji apklausa

Komentavimo iki data 2026-04-16

Žmogaus kraujui ir kraujo komponentams naudojamos plastikinės sulankstomos talpyklės. 3 dalis. Kraujo maišelių sistemos su įtaisytomis pagalbinėmis priemonėmis (ISO/DIS 3826‑3:2026)

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). The integrated features refer to: leucocyte filter; pre-donation sampling device; top and bottom bag; platelet storage bag; needle stick protection device. In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units. Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.

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prEN ISO 3826-2 Viešoji apklausa

Komentavimo iki data 2026-04-16

Žmogaus kraujui ir kraujo komponentams naudojamos plastikinės sulankstomos talpyklės. 2 dalis. Grafiniai simboliai, vartojami etiketėse ir naudojimo instrukcijose (ISO/DIS 3826‑2:2026)

This document addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in this document do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This document is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. This document may also be of assistance to different stages of the blood supply chain, e.g.: distributors of blood collection devices (manual or automated) or other representatives of manufacturers; blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product. This document does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this document may be suitable for application in other areas of medical technology.

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EN ISO 4135:2022/prA1 Viešoji apklausa

Komentavimo iki data 2026-04-14

Anestezijos ir kvėpavimo įranga. Aiškinamasis žodynas. 1 keitinys (ISO 4135:2022/DAM 1:2026)

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prEN ISO 9693 Viešoji apklausa

Komentavimo iki data 2026-04-07

Odontologija. Metalo su keramika ir keramikos su keramika sistemų suderinamumo tyrimai (ISO/FDIS 9693:2026)

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

Peržiūrėti metaduomenis

prEN ISO 23401-2 Viešoji apklausa

Komentavimo iki data 2026-04-07

Odontologija. Protezų pagrindo priderinimo medžiagos. 2 dalis. Trumpalaikio naudojimo minkštosios medžiagos (ISO/DIS 23401-2:2026)

This document specifies requirements for soft type denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis, and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. This document is not applicable to hard type denture lining materials or soft type denture lining materials for long-term use.

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prEN ISO 23401-3 Viešoji apklausa

Komentavimo iki data 2026-04-07

Odontologija. Protezų pagrindo priderinimo medžiagos. 3 dalis. Ilgalaikio naudojimo minkštosios medžiagos (ISO/DIS 23401-3:2026)

This document specifies requirements for soft type denture lining materials suitable for long-term use and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. These materials may also be used for maxillofacial prostheses. This document is not applicable to hard type denture lining materials or soft type denture lining materials for short-term use.

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prEN ISO 17254 Viešoji apklausa

Komentavimo iki data 2026-04-07

Odontologija. Ortodontinės spyruoklės (ISO/DIS 17254:2026)

ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

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prEN ISO 19253 Viešoji apklausa

Komentavimo iki data 2026-04-07

Sveikatos priežiūros gaminių sterilizavimas. Drėgnoji šiluma. Reikalavimai, keliami sterilizatoriams, naudojamiems vandeniniams skysčiams sandariose talpyklose galutinai sterilizuoti (ISO/DIS 19253:2026)

Specifies the requirements and the relevant tests for sterilizers intended to be used for the terminal sterilization of health care products (medical devices or medicinal products) presented as aqueous liquid in sealed containers. The container can be rigid, semi rigid or flexible. The sterilizing agent, moist heat, is created internally from the product, heating being achieved by use of saturated steam, mixtures of steam and a pressure ballasting non-condensing gas such as air or super-heated water in the sterilizer chamber. The sterilizers can be used in both a health care and industrial setting. This standard does not apply to sterilizers using saturated steam for the sterilization of the surfaces of medical devices or sterilizers used in laboratories. NOTE 1 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by EN 285 and EN 13060. Laboratory sterilizers are covered by some national standards. NOTE 2 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of other aqueous liquid in sealed containers such as veterinary products or some foodstuffs. Note 3 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the EN ISO 11607 series of standards.

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prEN ISO 23401-1 Viešoji apklausa

Komentavimo iki data 2026-03-31

Odontologija. Protezų pagrindo priderinimo medžiagos. 1 dalis. Kietosios medžiagos (ISO/DIS 23401-1:2026)

This document specifies the requirements for acrylic hard type materials used as chairside denture lining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer. Dentures which are relined by hard type denture lining materials specified by this document are limited to those of acrylic. This document is not applicable to soft type denture lining materials.

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prEN 868-8 Viešoji apklausa