natgillin/translations-raw huggingface dataset:
labelled as single use,
Vsaki komponenti, ki šteje za pripomoček in je tudi samostojno na voljo na trgu, se dodeli poseben UDI, razen če so komponente deli pripomočka, ki ga je mogoče konfigurirati in je tržen s svojim UDI.
packaged sterile,
Sistemom in paketom iz člena 22 se dodelijo lastni UDI, s katerim se ti sistemi in paketi tudi opremijo.
need for sterilization before use,
Proizvajalec pripomočku dodeli UDI na podlagi ustreznih standardov označevanja.
quantity of devices provided in a package,
Novi UDI-DI se določi ob vsaki spremembi, zaradi katere bi bil lahko pripomoček napačno identificiran in/ali kadar sledljivost ne bi bila več jasna.
critical warnings or contra-indications: e.g. containing latex or DEHP.
Novi UDI-DI se določi zlasti ob spremembi enega od naslednjih podatkovnih elementov podatkovne zbirke UDI:
Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI.
ime ali trgovsko ime,
The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging.
različica ali model pripomočka,
Higher levels do not include shipping containers.
označen za enkratno uporabo,
In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.
pakiran sterilno,
For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices.
pred uporabo je potrebna sterilizacija,
However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.
število pripomočkov v paketu,
If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes.
Zapis UDI (predstavitev UDI z AIDC in HRI) se namesti na oznaki ali na samem pripomočku in na vseh višjih stopnjah pakiranja pripomočka.
All parts and elements of the linear bar code shall be distinguishable and identifiable.
Višje stopnje ne zajemajo vsebnikov za prevoz.
If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label.
Kadar na embalaži enote uporabe ni dovolj prostora, se lahko zapis UDI namesti na naslednjo višjo stopnjo pakiranja.
For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.
Pri pripomočkih za enkratno uporabo razredov I in IIa, ki so pakirani in označeni posamično, zapis UDI na embalaži ni potreben, vendar mora biti nameščen na višji stopnji pakiranja, npr. na kartonu, ki vsebuje več posamično pakiranih pripomočkov.
The HRI format shall follow the rules of the UDI code-issuing entity.
Če pa izvajalec zdravstvenega varstva predvidoma ne bo imel dostopa – na primer v domači zdravstveni ustanovi – do višjih stopenj pakiranja, se UDI namesti na embalaži posameznega pripomočka.
If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.
Pri pripomočkih, ki so namenjeni izključno maloprodajnim prodajnim mestom, UDI-PI v AIDC ni treba nameščati na embalaži prodajnega mesta.
Devices that are reusable shall bear a UDI carrier on the device itself.
Kadar so zapisi AIDC, ki niso zapisi UDI, del oznake pripomočka, mora biti zapis UDI zlahka prepoznaven.
The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device.
Pri uporabi linearnih črtnih kod sta lahko UDI-DI in UDI-PI navedena povezano ali nepovezano v dveh ali več črtnih kodah.
The requirement of this Section shall not apply to devices in the following circumstances:
Vsi deli in elementi linearne črtne kode morajo biti razločni in prepoznavni.
any type of direct marking would interfere with the safety or performance of the device;
Če znatne ovire omejujejo uporabo AIDC in HRI na oznaki, mora biti na oznaki vsaj navedba v obliki AIDC.
the device cannot be directly marked because it is not technologically feasible.
Vendar mora biti pri pripomočkih, predvidenih za uporabo zunaj zdravstvenih ustanov, npr. pripomočkih za oskrbo na domu, na oznaki naveden HRI, čeprav potem ne bo več prostora za AIDC.
The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
Pri obliki HRI se upoštevajo pravila subjekta, ki izdaja kode UDI.
If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required.
Če proizvajalec uporablja tehnologijo RFID, se na oznako namesti tudi linearna ali 2D črtna koda v skladu s standardi subjektov za izdajanje.
In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.
Pripomočki, ki jih je mogoče ponovno uporabiti, so opremljeni z zapisom UDI na samem pripomočku.
The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.
Zapis UDI pripomočka za večkratno uporabo, ki ga je treba med posameznimi uporabami za paciente očistiti, razkužiti, sterilizirati ali obnoviti, je trajen in ostane berljiv po vsaki izvedbi postopka, s katerim se pripomoček med predvideno življenjsko dobo pripravi za nadaljnjo uporabo.
Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.
Zahteve iz tega oddelka se ne uporabljajo pri pripomočkih v naslednjih okoliščinah:
General principles of the UDI database
če bi katera koli vrsta neposredne oznake vplivala na varnost ali učinkovitost pripomočka;
The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex.
če pripomočka ni mogoče neposredno označiti, ker to ni tehnično izvedljivo.
Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database.
Zapis UDI ostane pri normalni uporabi in med celotno življenjsko dobo pripomočka berljiv.
Appropriate methods/procedures for validation of the data provided shall be implemented.
Če je zapis UDI zlahka berljiv ali v primeru AIDC optično berljiv prek embalaže pripomočka, zapisa UDI ni treba namestiti na embalažo.
Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.
Pri posameznih končnih pripomočkih, sestavljenih iz več delov, ki jih je treba pred prvo uporabo sestaviti, zadostuje, da se zapis UDI namesti le na enem delu posameznega pripomočka.
The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.
Zapis UDI je nameščen tako, da je mogoč dostop do AIDC pri normalnem delovanju ali shranjevanju.
The database shall allow for the linking of all the packaging levels of the device.
Zapisi s črtno kodo, ki vključujejo UDI-DI in UDI-PI, lahko vključujejo tudi podatke, ki so pomembni za delovanje pripomočka, ali druge podatke.
The data for new UDI-DIs shall be available at the time the device is placed on the market.
Splošna načela podatkovne zbirke UDI
Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.
Podatkovna zbirka UDI podpira uporabo vseh osrednjih podatkovnih elementov podatkovne zbirke UDI iz dela B te priloge.
Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.
Proizvajalci so odgovorni za začetno predložitev in posodabljanje informacij za identifikacijo in drugih podatkovnih elementov o pripomočku v podatkovni zbirki UDI.
The user interface of the UDI database shall be available in all official languages of the Union.
Izvajajo se ustrezne metode/postopke za validacijo predloženih podatkov.
The use of free-text fields shall, however, be minimized in order to reduce translations.
Proizvajalci redno preverjajo vse podatke, pomembne za pripomočke, ki so jih dali na trg, razen za pripomočke, ki niso več na trgu.
Data relating to devices that are no longer available on the market shall be retained in the UDI database.
Navedba UDI-DI v podatkovni zbirki UDI še ne pomeni, da je pripomoček v skladu s to uredbo.
Rules for specific device types
Podatkovna zbirka omogoča medsebojno povezovanje vseh stopenj pakiranja pripomočka.
Implantable devices:
Podatki za novi UDI-DI so na voljo v trenutku, ko je pripomoček dan na trg.
Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);
Proizvajalci v 30 dneh po spremembi elementa, zaradi katere ni treba določiti novega UDI-DI, posodobijo ustrezni zapis v podatkovni zbirki UDI.
The UDI-PI shall have at least the following characteristics:
Če je le mogoče, se za podatkovno zbirko UDI uporabljajo mednarodno sprejeti standardi za predložitev podatkov in posodobitve
the serial number for active implantable devices,
Podatki v zvezi s pripomočki, ki niso več na trgu, se ohranijo v podatkovni zbirki UDI.
the serial number or lot number for other implantable devices.
Pravila za posebne vrste naprav
The UDI of the implantable device shall be identifiable prior to implantation.
Pripomočki za vsaditev
Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses
Pripomočki za vsaditev se na najnižji stopnji pakiranja (na enotah pakiranja) opredelijo ali označijo z UDI (UDI-DI in UDI-PI) z uporabo AIDC.
The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.
UDI-PI vključuje vsaj naslednje značilnosti:
The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
serijsko številko za aktivne pripomočke za vsaditev,
Systems and procedure packs as referred to in Article 22
serijsko številko ali številko partije za druge pripomočke za vsaditev.
The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.
UDI pripomočka za vsaditev je prepoznaven pred vsaditvijo.
Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.
Pripomočki za večkratno uporabo, pri katerih je med posameznimi uporabami potrebno čiščenje, razkuževanje, sterilizacija ali obnovitev
Exemptions:
UDI teh pripomočkov se namestijo na pripomoček in so berljivi po vsakem postopku, s katerim se pripomoček pripravi za naslednjo uporabo.
individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;
Značilnosti UDI-PI, npr. številko partije ali serijsko številko, določi proizvajalec.
devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.
Sistemi in paketi iz člena 22
Placement of the UDI carrier on systems or procedure packs
Fizična ali pravna oseba iz člena 22 je odgovorna za identifikacijo sistema ali paketa z UDI, vključno z UDI-DI in UDI-PI.
The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
Pripomočki v sistemu ali paketu so opremljeni z zapisom UDI na embalaži ali samem pripomočku.
The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.
Izjeme:
Configurable devices:
posameznih odstranljivih pripomočkov za enkratno uporabo, katerih uporaba je splošno znana osebam, ki so jim namenjeni, in jih vsebuje sistem ali paket ter niso namenjeni individualni uporabi zunaj okvira sistema ali paketa, ni treba opremiti s svojim zapisom UDI;
A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.
pripomočkov, ki jih ni treba opremiti z zapisom UDI na ustrezni stopnji pakiranja, tudi ni treba opremiti z zapisom UDI, če so vključeni v sistem ali paket.
The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group.
Namestitev zapisa UDI na sistem ali paket
A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.
zapis UDI v sistemu ali paketu je praviloma pritrjen na zunanji strani embalaže;
A configurable device UDI-PI shall be assigned to each individual configurable device.
zapis UDI je berljiv ali v primeru AIDC optično berljiv ne glede na to, ali je nameščen na zunanji strani embalaže sistema ali paketa ali znotraj prosojne embalaže.
The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.
Pripomočki, ki jih je mogoče konfigurirati
Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.
UDI se dodeli za pripomoček, ki ga je mogoče konfigurirati, v celoti in se imenuje UDI pripomočka, ki ga je mogoče konfigurirati.
Device Software
UDI-DI, ki ga je mogoče konfigurirati, se dodeli skupinam konfiguracij in ne konfiguracijam znotraj skupine.
UDI assignment Criteria
Skupina konfiguracij je opredeljena kot zbirka mogočih konfiguracij danega pripomočka, kot je opisano v tehnični dokumentaciji.
The UDI shall be assigned at the system level of the software.
UDI-PI, ki ga je mogoče konfigurirati, se dodeli vsakemu posameznemu pripomočku, ki ga je mogoče konfigurirati.
Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.
Zapis UDI pripomočka, ki ga je mogoče konfigurirati, se namesti na sestavo, za katero je najmanj verjetno, da bi bila med življenjsko dobo sistema zamenjana, in se opredeljuje kot UDI pripomočka, ki ga je mogoče konfigurirati.
The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.
Vsaki komponenti, ki šteje za pripomoček in je tudi samostojno na voljo na trgu, se dodeli poseben UDI.
A new UDI-DI shall be required whenever there is a modification that changes:
Programska oprema za pripomočke
the original performance;
Merila za dodeljevanje UDI
the safety or the intended use of the software;
UDI se dodeli na sistemski ravni programske opreme.
interpretation of data.
Ta zahteva velja samo za programsko opremo, ki je samostojno na voljo na trgu, in programsko opremo, ki je sama pripomoček.
Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.
Identifikacija programske opreme se šteje za proizvodni kontrolni mehanizem in je prikazana v UDI-PI.
Minor software revisions shall require a new UDI-PI and not a new UDI-DI.
Nov UDI-DI se določi ob vsaki spremembi, pri kateri se spremeni:
Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency.
prvotna učinkovitost,
Minor software revisions shall be identified by a manufacturer-specific form of identification.
varnost ali predvidena uporaba programske opreme,
UDI placement criteria for software
razlaga podatkov.
where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI.
Te spremembe vključujejo nove ali spremenjene algoritme, strukture podatkovne zbirke, operativno platformo, arhitekturo, novi uporabniški vmesnik ali nove kanale za interoperabilnost.
The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software;
Manjše spremembe programske opreme zahtevajo nov UDI-PI, ne pa tudi novega UDI-DI.
the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an ‘about’ file, or included on the start-up screen;
Manjše spremembe programske opreme so običajno povezane s popravki programskih napak, izboljšanjem uporabnosti, nepovezanim z varnostjo, varnostnimi popravki ali učinkovitostjo delovanja.
software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API);
Manjše spremembe programske opreme se opredelijo s posebnimi identifikacijami proizvajalca.
only the human readable portion of the UDI shall be required in electronic displays of the software.
Merila namestitve UDI za programsko opremo
The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.;
Kadar se programska oprema dostavi na fizičnem nosilcu, npr. na CD ali DVD, je vsaka raven pakiranja opremljena z berljivo predstavitvijo in predstavitvijo celotnega UDI z AIDC.
the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.
UDI, ki se uporabi za fizični nosilec, na katerem je shranjena programska oprema, in njegovo embalažo, je enak UDI, dodeljenemu programski opremi na sistemski ravni.
ANNEX VII
UDI se uporabniku prikaže na zlahka dostopnem zaslonu v obliki zlahka berljivega golega besedila, npr. v datoteki „opis“ ali v oknu, ki se odpre ob zagonu.
REQUIREMENTS TO BE MET BY NOTIFIED BODIES
Programska oprema brez uporabniškega vmesnika, npr. vmesna programska oprema za pretvorbo slike, mora omogočati prikaz UDI prek vmesnika aplikacijskih programov (API).
ORGANISATIONAL AND GENERAL REQUIREMENTS
V elektronskem prikazovalniku programske opreme mora biti prikazan samo berljivi del UDI.
Legal status and organisational structure
Oznaka UDI z uporabo AIDC ni potrebna pri elektronskih prikazovalnikih, na primer v meniju „opis“, na pozdravnem zaslonu ipd.
Each notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect.
Berljiva oblika UDI za programsko opremo vključuje identifikatorje aplikacije (AI) za standarde, ki jih uporabljajo subjekti za izdajanje, da bi uporabnik lažje identificiral UDI in ugotovil, kateri standard se uporablja za oblikovanje UDI.
Its legal personality and status shall be fully documented.
PRILOGA VII
Such documentation shall include information about ownership and the legal or natural persons exercising control over the notified body.
ZAHTEVE, KI JIH MORAJO IZPOLNJEVATI PRIGLAŠENI ORGANI
If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented.
ORGANIZACIJSKE IN SPLOŠNE ZAHTEVE
In such cases, the requirements of Section 1.2 are applicable to both the notified body and the organisation to which it belongs.
Pravni status in organizacijska struktura
If a notified body wholly or partly owns legal entities established in a Member State or in a third country or is owned by another legal entity, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented.
Vsak priglašeni organ je ustanovljen v skladu z nacionalnim pravom države članice ali v skladu s pravom tretje države, s katero je Unija sklenila sporazum v zvezi s tem.
Personnel of those entities performing conformity assessment activities under this Regulation shall be subject to the applicable requirements of this Regulation.
Njegova pravna osebnost in status sta v celoti dokumentirana.
The organisational structure, allocation of responsibilities, reporting lines and operation of the notified body shall be such that they ensure that there is confidence in the performance by the notified body and in the results of the conformity assessment activities it conducts.
Ta dokumentacija vključuje informacije o lastništvu ter pravnih ali fizičnih osebah, ki nadzorujejo priglašeni organ.
The notified body shall clearly document its organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel who may have an influence upon the performance by the notified body and upon the results of its conformity assessment activities.
Če je priglašeni organ pravni subjekt, ki je del večje organizacije, so dejavnosti te organizacije ter organizacijska struktura in upravljanje ter odnos s priglašenim organom jasno dokumentirani.
The notified body shall identify the persons in top-level management that have overall authority and responsibility for each of the following:
V tem primeru se zahteve iz oddelka 1.2 uporabljajo za priglašeni organ in organizacijo, ki ji pripada.
the provision of adequate resources for conformity assessment activities;
Če so pravne osebe s sedežem v državi članici ali tretji državi v celoti ali deloma v lasti priglašenega organa ali je ta organ v lasti druge pravne osebe, so dejavnosti in odgovornosti navedenih oseb ter njihovi pravni in operativni odnosi s priglašenim organom jasno opredeljeni in dokumentirani.
the development of procedures and policies for the operation of the notified body;
Veljavne zahteve te uredbe se uporabljajo za osebje navedenih oseb, ki opravlja dejavnosti ugotavljanja skladnosti v skladu s to uredbo.
the supervision of implementation of the procedures, policies and quality management systems of the notified body;
Organizacijska struktura, dodelitev pristojnosti, poročanje in delovanje priglašenega organa so takšni, da zagotavljajo zaupanje v učinkovitost priglašenega organa in v rezultate dejavnosti ugotavljanja skladnosti, ki jih izvaja.
the supervision of the notified body's finances;
Priglašeni organ jasno dokumentira svojo organizacijsko strukturo in funkcije, pristojnosti in pooblastila svojega najvišjega vodstva in drugega osebja, ki lahko vpliva na učinkovitost priglašenega organa in na rezultate njegovih dejavnosti ugotavljanja skladnosti.
the activities and decisions taken by the notified body, including contractual agreements;
Priglašeni organ določi osebe izmed najvišjega vodstva, ki so splošno pristojne in odgovorne za naslednje:
the delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities;
zagotovitev ustreznih sredstev za dejavnosti ugotavljanja skladnosti;
the interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies.
razvoj postopkov in politik za delovanje priglašenega organa;
Independence and impartiality
nadzor izvajanja postopkov, politik in sistemov vodenja kakovosti priglašenega organa;