natgillin/translations-raw huggingface dataset:
It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the labelling.
Oznaka CE je sestavljena iz začetnic „CE“ v naslednji obliki:
Additional information required in specific cases
Pri pomanjšanju ali povečanju oznake CE se upoštevajo razmerja, ki so prikazana na zgornji risbi.
In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps.
Različni komponenti oznake CE imata praktično enako navpično dimenzijo, ki ne sme biti krajša od 5 mm.
In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with regard to packaging, sterilisation and maintenance of sterility.
Ta najmanjša dimenzija lahko odstopa pri majhnih pripomočkih.
The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
PRILOGA VI
In the case of devices containing tissues, cells and substances of animal, human or microbial origin, information on the origin of such material and on the conditions in which it was collected.
INFORMACIJE, KI JIH JE TREBA PREDLOŽITI OB REGISTRACIJI PRIPOMOČKOV IN GOSPODARSKIH SUBJEKTOV V SKLADU S ČLENOMA 26(3) IN 28, OSNOVNI ELEMENTI PODATKOV, KI JIH JE TREBA PREDLOŽITI ZA PODATKOVNO ZBIRKO UDI SKUPAJ Z UDI-DI V SKLADU S ČLENOMA 25 IN 26, IN SISTEM UDI
In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.
DEL A
If the device is to be connected to other equipment in order to operate as intended, a description of the resulting combination including proof that it conforms to the general safety and performance requirements set out in Annex I when connected to any such equipment having regard to the characteristics specified by the manufacturer.
INFORMACIJE, KI JIH JE TREBA PREDLOŽITI OB REGISTRACIJI PRIPOMOČKOV IN GOSPODARSKIH SUBJEKTOV V SKLADU S ČLENOMA 26(3) IN 28
ANNEX III
Proizvajalci ali, kjer je to ustrezno, pooblaščeni predstavniki oziroma uvozniki sporočijo informacije iz oddelka 1 in zagotovijo, da so podatki na njihovih pripomočkih iz oddelka 2 popolni in pravilni ter da jih je zadevna stran posodobila.
TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
Informacije v zvezi z gospodarskim subjektom
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
Vrsta gospodarskega subjekta (proizvajalec, pooblaščeni predstavnik ali uvoznik);
The post-market surveillance plan drawn up in accordance with Article 79.
ime, naslov in kontaktni podatki gospodarskega subjekta;
The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 78.
kadar informacije predloži druga oseba v imenu gospodarskih subjektov iz oddelka 1.1., ime, naslov in kontaktni podatki te osebe;
The post-market surveillance plan shall address the collection and utilisation of available information, in particular:
ime, naslov in kontaktni podatki osebe ali oseb, odgovornih za skladnost z zakonodajo iz člena 15.
information concerning serious incidents, including information from PSURs, and field safety corrective actions,
Informacije v zvezi s pripomočkom
records referring to non-serious incidents and data on any undesirable side-effects,
Osnovni UDI-DI;
information from trend reporting,
vrsta, številka in datum izteka veljavnosti certifikata, ki ga je izdal priglašeni organ, ter ime ali identifikacijska številka tega priglašenega organa in povezava na informacije, ki so navedene na certifikatu in jih je priglašeni organ vnesel v elektronski sistem o priglašenih organih in certifikatih;
relevant specialist or technical literature, databases and/or registers,
država članica, v kateri pripomoček bo ali je bil dan na trg v Uniji;
information, including feedbacks and complaints, provided by users, distributors and importers, and
v primeru pripomočkov razreda B, razreda C ali razreda D: države članice, v katerih pripomoček je ali bo na voljo;
publicly-available information about similar medical devices.
prisotnost človeških tkiv, celic ali njihovih derivatov (da/ne);
The post-market surveillance plan shall cover at least:
prisotnost živalskih tkiv, celic ali njihovih derivatov, kot so navedeni v Uredbi (EU) št. 722/2012 (da/ne);
a proactive and systematic process to collect any information referred to in point (a).
prisotnost celic ali snovi mikrobnega izvora (da/ne);
The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
razred tveganja pripomočka;
effective and appropriate methods and processes to assess the collected data;
kjer je to ustrezno, enotno identifikacijsko številko študije učinkovitosti;
suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
v primeru pripomočkov, ki jih zasnuje in izdela druga pravna ali fizična oseba, kot je navedena v členu 10(14), ime, naslov in kontaktni podatki navedene pravne ali fizične osebe;
effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
v primeru pripomočkov razreda C ali razreda D, povzetek o varnosti in učinkovitosti;
methods and protocols to manage the events subject to the trend report as provided for in Article 83, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
status pripomočka (na trgu, ni več na trgu, odpoklican, sprožen varnostni korektivni ukrep);
methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
navedba, ali gre za „nov“ pripomoček.
reference to procedures to fulfil the manufacturers obligations laid down in Articles 78, 79 and 81;
Pripomoček šteje za „novega“, če:
systematic procedures to identify and initiate appropriate measures including corrective actions;
takšen pripomoček ni bil neprekinjeno na voljo na trgu Unije v preteklih treh letih za zadevni analit ali drug parameter;
effective tools to trace and identify devices for which corrective actions might be necessary; and
postopek vključuje analitično tehnologijo, ki se v preteklih treh letih ni stalno uporabljala v zvezi z danim analitom ali drugim parametrom na trgu Unije;
a PMPF plan as referred to in Part B of Annex XIII, or a justification as to why a PMPF is not applicable.
navedba, ali je pripomoček predviden za samotestiranje ali testiranje ob pacientu.
The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.
DEL B
ANNEX IV
OSNOVNI ELEMENTI PODATKOV, KI JIH JE TREBA PREDLOŽITI ZA PODATKOVNO ZBIRKO UDI SKUPAJ Z UDI-DI V SKLADU S ČLENOMA 25 IN 26
EU DECLARATION OF CONFORMITY
Proizvajalec za podatkovno zbirko UDI sporoči UDI-DI in naslednje informacije v zvezi s proizvajalcem in pripomočkom:
The EU declaration of conformity shall contain the following information:
količino na paket;
Name, registered trade name or registered trade mark and, if already issued, SRN referred to in Article 28 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
osnovni UDI-DI iz člena 24(6) in kakršne koli dodatne UDI-DI;
A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
način nadzora proizvodnje pripomočka (rok uporabe ali datum izdelave, številka partije, serijska številka);
The Basic UDI-DI as referred to in Part C of Annex VI;
po potrebi identifikator „enote uporabe“ pripomočka UDI (kadar UDI ni označen na ravni „enote uporabe“ pripomočka, se dodeli identifikator „enote uporabe“ pripomočka UDI, da se uporaba pripomočka poveže s pacientom);
Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose.
ime in naslov proizvajalca, kot sta navedena na oznaki;
Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
enotna registrska številka, dodeljena v skladu s členom 28(2);
Risk class of the device in accordance with the rules set out in Annex VIII;
po potrebi ime in naslov pooblaščenega predstavnika, kot je navedeno na oznaki;
A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
koda iz nomenklature o medicinskih pripomočkih, kot je določeno v členu 23;
References to any CS used and in relation to which conformity is declared;
kadar je to ustrezno, ime ali trgovsko ime;
Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
kadar je to ustrezno, model pripomočka, sklicevanje ali kataloška številka;
Where applicable, additional information;
dodatni opis izdelka (neobvezno);
Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.
kadar je to ustrezno, pogoji skladiščenja in/ali ravnanja, kot je navedeno na oznaki ali v navodilih za uporabo;
ANNEX V
kadar je to ustrezno, dodatna trgovska imena pripomočka;
CE MARKING OF CONFORMITY
ali je označen kot pripomoček za enkratno uporabo (da/ne);
The CE marking shall consist of the initials ‘CE’ taking the following form:
kadar je to ustrezno, največje število ponovnih uporab;
If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected.
ali je pripomoček označen kot sterilen (da/ne);
The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm.
ali je pred uporabo potrebna sterilizacija (da/ne);
This minimum dimension may be waived for small-scale devices.
povezava URL za dodatne informacije, na primer elektronska navodila za uporabo (neobvezno);
ANNEX VI
kadar je to ustrezno, nujna opozorila ali kontraindikacije;
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM
status pripomočka na trgu (ni več na trgu, odpoklican, sprožen varnostni korektivni ukrep).
PART A
DEL C
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28
SISTEM UDI
Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party.
Samodejna identifikacija in zajemanje podatkov (AIDC – Automatic Identification and Data Capture)
Information relating to the economic operator
AIDC je tehnologija, ki se uporablja za samodejno zajemanje podatkov.
type of economic operator (manufacturer, authorised representative, or importer),
Tehnologija AIDC zajema črtne kode, pametne kartice, biometrijo in RFID.
name, address and contact details of the economic operator,
Osnovni UDI-DI.
where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
Osnovni UDI-DI je primarni identifikator modela pripomočka.
name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15,
To je identifikator pripomočka, določen na ravni enote uporabe pripomočka.
Information relating to the device
Je glavni element v evidencah podatkovne zbirke UDI in je naveden v ustreznih certifikatih in izjavah o skladnosti.
Basic UDI-DI,
Identifikator enote uporabe pripomočka
type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
Namen identifikatorja enote uporabe pripomočka je povezati uporabo pripomočka s pacientom, kadar na posameznem pripomočku UDI ni označen na ravni njegove enote uporabe, na primer če je več enot istega pripomočka pakiranih skupaj.
Member State in which the device shall or has been placed on the market in the Union,
Pripomoček, ki ga je mogoče konfigurirati
in the case of class B, class C or class D devices: Member States where the device is or is to be made available,
Pripomoček, ki ga je mogoče konfigurirati, je pripomoček, ki ga sestavlja več komponent in jih lahko proizvajalec sestavi v več konfiguracijah.
presence of tissues, cells, or, their derivatives, of human origin (y/n),
Posamezne komponente so tudi same lahko pripomočki.
presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No 722/2012(y/n),
Konfiguracija
presence of cells or substances of microbial origin (y/n),
Konfiguracija je kombinacija delov opreme, kot jo določi proizvajalec, ki delujejo skupaj kot pripomoček za doseganje predvidenega namena.
risk class of the device,
Kombinacijo delov je mogoče spremeniti, naravnati ali prilagoditi v skladu s posebnimi potrebami.
where applicable, the single identification number of the performance study,
UDI-DI je edinstvena številčna ali alfanumerična koda, ki posebej označuje model pripomočka in se uporablja tudi kot „ključ za dostop“ do informacij, shranjenih v podatkovni zbirki UDI.
in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(14), the name, address and contact details of that legal or natural person,
Berljiva razlaga –(Human Readable Interpretation- HRI)
in the case of class C or D devices, the summary of safety and performance,
Berljiva razlaga je čitljiva oblika podatkovnih znakov, zakodiranih v zapisu UDI.
status of the device (on the market, no longer placed on the market, recalled, field safety corrective Action initiated),
Stopnje pakiranja
indication as to whether the device is a ‘new’ device.
Stopnje pakiranja pomenijo različne ravni pakiranja pripomočkov, ki vsebuje določeno količino pripomočkov, npr. vsak karton ali zaboj.
A device shall be considered to be ‘new’ if:
Identifikator proizvodnje (UDI-PI)
there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter;
UDI-PI je številčna ali alfanumerična koda, ki opredeljuje proizvodno enoto pripomočka.
the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years.
Različne vrste UDI-PI vključujejo serijsko številko, številko partije, identifikator programske opreme in datum proizvodnje ali roka uporabe ali oba datuma.
indication as to whether the device is intended for self-testing or near-patient testing.
Radiofrekvenčna identifikacija (v nadaljnjem besedilu: RFID)
PART B
RFID je tehnologija, ki uporablja komunikacijo prek radijskih valov za izmenjavo podatkov med čitalnikom in elektronsko tablico, pritrjeno na predmet, za identifikacijo.
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26
Vsebniki za prevoz
The manufacturer shall provide to the UDI database the UDI-DI and the following information relating to the manufacturer and the device:
Vsebnik za prevoz je vsebnik, katerega sledljivost se nadzoruje s postopki, značilnimi za logistične sisteme.
quantity per package configuration,
Edinstveni identifikator pripomočka (v nadaljnjem besedilu: UDI – Unique Device Identifier)
the Basic UDI-DI as referred to in Article 24(6) and any additional UDI-DIs,
UDI je zaporedje številčnih ali alfanumeričnih znakov, določenih s splošno sprejetim standardom identifikacije in kodiranja pripomočka.
the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number),
Z njim je mogoče nedvoumno opredeliti poseben pripomoček na trgu.
if applicable, the ‘unit of use’ UDI-DI (where a UDI is not labelled on the device at the level of its ‘unit of use’, a ‘unit of use’ UDI-DI shall be assigned so as to associate the use of a device with a patient),
UDI je sestavljen iz UDI-DI in UDI-PI.
name and address of the manufacturer, as indicated on the label,
Beseda „edinstveni“ ne pomeni, da se posamezne proizvodne enote označujejo s serijskimi številkami.
the SRN issued in accordance with Article 28(2),
Zapis UDI
if applicable, name and address of the authorised representative (as indicated on the label),
Zapis UDI je način sporočanja UDI z uporabo AIDC in, če je to ustrezno, HRI.
the medical device nomenclature code as provided for in Article 23,
Ti zapisi so lahko med drugim ID/linearna črtna koda, 2D/matrična črtna koda, RFID.
if applicable, name or trade name,
Splošne zahteve
if applicable, device model, reference, or catalogue number,
Namestitev UDI je dodatna zahteva – ne nadomešča drugih zahtev za označevanje ali etiketiranje iz Priloge I k tej uredbi.
additional product description (optional),
Proizvajalec določi in vzdržuje edinstvene UDI na svojih pripomočkih.
if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
Samo proizvajalec lahko namesti UDI na pripomoček ali njegovo embalažo.
if applicable, additional trade names of the device,
Uporabljajo se lahko samo standardi za kodiranje, katere določijo subjekti za izdajanje, ki jih v skladu s členom 24(2) imenuje Komisija.
labelled as a single use device (y/n),
UDI
if applicable, the maximum number of reuses,
UDI se dodeli samemu pripomočku ali njegovemu pakiranju.
device labelled sterile (y/n),
Višje stopnje pakiranja imajo svoj UDI.
need for sterilisation before use (y/n),
Vsebniki za prevoz so izvzeti iz zahteve iz oddelka 3.1.
URL for additional information, such as electronic instructions for use (optional),
UDI tako na primer ni potreben na logistični enoti; če izvajalec zdravstvenega varstva naroči več pripomočkov in pri tem uporabi UDI ali številko modela posameznih pripomočkov, proizvajalec pa te pripomočke namesti v vsebnike zaradi prevoza ali zaščite posamično pakiranih pripomočkov, za vsebnik (logistično enoto) ne veljajo zahteve glede UDI.
if applicable, critical warnings or contra-indications,
UDI je sestavljen iz dveh delov: UDI-DI in UDI-PI.
status of the device (on the market, no longer placed on the market, recalled, field safety action initiated).
UDI-DI je edinstven na vseh stopnjah pakiranja pripomočka.
PART C
Če so na oznaki navedeni številka partije, serijska številka, identifikator programske opreme ali rok uporabe, so del UDI-PI.
THE UDI SYSTEM
Če je na oznaki naveden tudi datum izdelave, ga ni treba vključiti v UDI-PI.
Automatic identification and data capture (‘AIDC’)
Če je na oznaki naveden samo datum izdelave, se ta uporablja kot UDI-PI.
AIDC is a technology used to automatically capture data.
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.
AIDC technologies include bar codes, smart cards, biometrics and RFID.
Kompletom se dodelijo njihovi lastni UDI, s katerim se ti kompleti tudi opremijo.
Basic UDI-DI
Proizvajalec pripomočku dodeli UDI na podlagi ustreznih standardov označevanja.
The Basic UDI-DI is the primary identifier of a device model.
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.
It is the DI assigned at the level of the device unit of use.
Novi UDI-DI se določi zlasti ob spremembi enega od naslednjih podatkovnih elementov podatkovne zbirke UDI:
It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
ime ali trgovsko ime,
Unit of Use DI
različica ali model pripomočka,
The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
označen za enkratno uporabo,
Configurable device
pakiran sterilno,
A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations.
pred uporabo je potrebna sterilizacija,
Those individual components may be devices in themselves.
število pripomočkov v paketu,
Configuration
nujna opozorila ali kontraindikacije.
Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose.
Proizvajalci, ki prepakirajo ali na novo označijo pripomočke s svojimi oznakami, ohranijo evidenco o UDI proizvajalca originalne opreme.
The combination of items may be modified, adjusted or customised to meet specific needs.
Zapis UDI (predstavitev UDI z AIDC in HRI) se namesti na oznaki in na vseh višjih stopnjah pakiranja pripomočka.
The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
Višje stopnje ne zajemajo vsebnikov za prevoz.
Human Readable Interpretation (HRI)
Kadar na embalaži enote uporabe ni dovolj prostora, se lahko zapis UDI namesti na naslednjo višjo stopnjo pakiranja.
HRI is a legible interpretation of the data characters encoded in the UDI carrier.
Pri pripomočkih za enkratno uporabo razred A in razreda B, 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 paketov.
Packaging levels
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.
Packaging levels means the various levels of device packaging that contain a fixed quantity of devices, such as a carton or case.
Pri pripomočkih, ki so namenjeni izključno maloprodajnim prodajnim mestom, UDI-PI v AIDC ni treba nameščati na embalažo prodajnega mesta.
Production Identifier (UDI-PI)
Kadar so zapisi AIDC, ki niso zapisi UDI, del oznake izdelka, mora biti zapis UDI zlahka prepoznaven.
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
Pri uporabi linearnih črtnih kod sta lahko UDI-DI in UDI-PI navedena povezano ali nepovezano v dveh ali več črtnih kodah.
The different types of UDI-PI(s) include serial number, lot number, software identification and manufacturing or expiry date or both types of date.
Vsi deli in elementi linearne črtne kode morajo biti razločni in prepoznavni.
Radio Frequency Identification (‘RFID’)
Če znatne ovire omejujejo uporabo AIDC in HRI na oznaki, mora biti na oznaki vsaj navedba v obliki AIDC.