natgillin/translations-raw huggingface dataset:
REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
PRILOZI
Performance characteristics
I. Opći zahtjevi sigurnosti i učinkovitosti
Devices shall be designed and manufactured in such a way that they are suitable for the purposes referred to in point (2) of Article 2, as specified by the manufacturer, and suitable with regard to the performance they are intended to achieve, taking account of the generally acknowledged state of the art.
Tehnička dokumentacija
They shall achieve the performances, as stated by the manufacturer and in particular, where applicable:
Tehnička dokumentacija o posttržišnom nadzoru
the analytical performance, such as, analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross-reactions; and
EU izjava o sukladnosti
the clinical performance, such as diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations.
V. Oznaka sukladnosti CE
The performance characteristics of the device shall be maintained during the lifetime of the device as indicated by the manufacturer.
Informacije koje se prilažu registraciji proizvoda i gospodarskih subjekata u skladu s člankom 26. stavkom 3. te člankom 28. i temeljni podatkovni elementi koje treba dostaviti u bazu podataka jedinstvene identifikacije proizvoda zajedno s UDI-DI-jem u skladu s člancima 25. i 26. te sustav jedinstvene identifikacije proizvoda
Where the performance of devices depends on the use of calibrators and/or control materials, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures and/or suitable reference materials of a higher metrological order.
Zahtjevi koje trebaju ispuniti prijavljena tijela
Where available, metrological traceability of values assigned to calibrators and control materials shall be assured to certified reference materials or reference measurement procedures.
Pravila razvrstavanja
The characteristics and performances of the device shall be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions:
Ocjenjivanje sukladnosti na temelju sustava upravljanja kvalitetom i ocjenjivanja tehničke dokumentacije
for devices for self-testing, performances obtained by laypersons;
Ocjenjivanje sukladnosti na temelju ispitivanja tipa
for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances).
Ocjenjivanje sukladnosti na temelju jamstva kvalitete proizvodnje
Chemical, physical and biological properties
Potvrde koje izdaje prijavljeno tijelo
Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled.
Procjena učinkovitosti, studije učinkovitosti i posttržišno praćenje učinkovitosti
Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.
Intervencijske studije kliničke učinkovitosti i određene druge studije učinkovitosti
Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices.
Korelacijska tablica
Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.
PRILOG I.
Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably practicable the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.
OPĆI ZAHTJEVI SIGURNOSTI I UČINKOVITOSTI
Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council [1], and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council [2].10.4.
OPĆI ZAHTJEVI
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device, taking into account the device and the nature of the environment in which it is intended to be used.
Proizvodi postižu učinkovitost koju im je namijenio njihov proizvođač te su projektirani i proizvedeni tako da u uobičajenim uvjetima uporabe odgovaraju svojoj namjeni.
Infection and microbial contamination
Sigurni su i učinkoviti te ne ugrožavaju kliničko stanje ili sigurnost pacijenata ili sigurnost i zdravlje korisnika ili, ako je to primjenjivo, drugih osoba, uz uvjet da svi rizici koji se mogu povezati s njihovom uporabom predstavljaju prihvatljive rizike u usporedbi s koristima za pacijenta te su kompatibilni s visokom razinom zaštite zdravlja i sigurnosti, uzimajući u obzir općepriznata najnovija dostignuća.
Devices and their manufacturing processes shall be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or, where applicable, other persons.
Zahtjev za svođenje rizika na najmanju moguću mjeru sadržan u ovom Prilogu odnosi se na svođenje rizika na najmanju moguću mjeru bez nepoželjnog utjecaja na omjer koristi i rizika.
The design shall:
Proizvođači uspostavljaju, provode, dokumentiraju i održavaju sustav upravljanja rizicima.
allow easy and safe handling;
Upravljanje rizicima smatra se kontinuiranim iterativnim procesom kojim je obuhvaćen cijeli životni vijek proizvoda te za koji je potrebno redovito sustavno ažuriranje.
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use;
Pri provedbi upravljanja rizicima proizvođači:
and, where necessary
uspostavljaju i dokumentiraju plan upravljanja rizicima za svaki proizvod;
prevent microbial contamination of the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen.
identificiraju i analiziraju poznate i predvidljive opasnosti povezane sa svakim proizvodom;
Devices labelled either as sterile or as having a specific microbial state shall be designed, manufactured and packaged to ensure that their sterile condition or microbial state is maintained under the transport and storage conditions specified by the manufacturer until that packaging is opened at the point of use, unless the packaging which maintains their sterile condition or microbial state is damaged.
ocjenjuju i procjenjuju rizike koji se pojavljuju tijekom predviđene uporabe i tijekom razumno predvidljive pogrešne uporabe i koji su s njima povezani;
Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods.
uklanjaju ili kontroliraju rizike navedene u točki (c) u skladu sa zahtjevima iz odjeljka 4.;
Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities.
procjenjuju utjecaj informacija proizašlih iz faze proizvodnje te, konkretno, iz sustava posttržišnog nadzora, o opasnostima i njihovoj učestalosti pojavljivanja, o ocjenama njihovih pripadajućih rizika, kao i o cjelokupnom riziku, omjeru koristi i rizika te prihvatljivosti rizika; i
Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.
na temelju procjene utjecaja informacija iz točke (e), ako je to potrebno, izmjenjuju mjere kontrole u skladu sa zahtjevima iz odjeljka 4.
The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile.
Mjere kontrole rizika koje proizvođači usvoje za projektiranje i proizvodnju proizvoda sukladne su s načelima sigurnosti, uzimajući u obzir općepriznata najnovija dostignuća.
Devices incorporating materials of biological origin
Radi smanjenja rizika proizvođači upravljaju rizicima tako da se preostali rizik povezan sa svakom opasnošću, kao i cjelokupni preostali rizik ocijeni kao prihvatljiv.
Where devices include tissues, cells and substances of animal, human or microbial origin, the selection of sources, the processing, preservation, testing and handling of tissues, cells and substances of such origin and control procedures shall be carried out so as to provide safety for user or other person.
Pri odabiru najprikladnijih rješenja proizvođači prema sljedećem redoslijedu prvenstva:
In particular, safety with regard to microbial and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.
uklanjaju ili svode rizike na najmanju moguću mjeru sigurnim projektiranjem i proizvodnjom;
This might not apply to certain devices if the activity of the microbial and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device.
prema potrebi poduzimaju odgovarajuće zaštitne mjere u vezi s rizicima koji se ne mogu ukloniti, uključujući alarme ako je to potrebno; i
Construction of devices and interaction with their environment
pružaju informacije o sigurnosti (upozorenja / mjere opreza / kontraindikacije) te, prema potrebi, izobrazbu korisnicima.
If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, shall be safe and shall not impair the specified performances of the devices.
Proizvođači obavješćuju korisnike o svim preostalim rizicima.
Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use.
Pri uklanjanju ili smanjenju rizika povezanih s pogreškama pri uporabi proizvođač:
Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
smanjuje, koliko je god to moguće, rizike povezane s ergonomskim značajkama proizvoda i okruženjem u kojem se proizvod namjerava upotrebljavati (projektiranje za sigurnost pacijenta) te
the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features;
uzima u obzir tehničko znanje, iskustvo, obrazovanje, izobrazbu i okruženje uporabe te, ako je to primjenjivo, zdravstvena i fizička stanja predviđenih korisnika (projektiranje za laike, stručne osobe, osobe s invaliditetom ili druge korisnike).
risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences;
Kada je proizvod podvrgnut opterećenjima do kojih može doći u normalnim uvjetima uporabe te je održavan na odgovarajući način u skladu s uputama proizvođača, nepoželjan utjecaj na svojstva i učinkovitost proizvoda ne smije tolik da zdravlje ili sigurnost pacijenta ili korisnika te, ako je to primjenjivo, drugih osoba budu ugroženi za vrijeme životnog vijeka proizvoda, kako ga je naveo proizvođač.
the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use;
Proizvodi moraju biti projektirani, proizvedeni i pakirani tako da tijekom prijevoza i skladištenja, na primjer zbog oscilacija u temperaturi i vlazi, nema nepoželjnog učinka na njihova svojstva i učinkovitost tijekom predviđene uporabe ako se vodi računa o uputama i informacijama koje pruža proizvođač.
the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts;
Svi poznati i predvidljivi rizici te svi neželjeni učinci svode se na najmanju moguću mjeru i prihvatljivi su u usporedbi s procijenjenim potencijalnim koristima koje za pacijente i/ili korisnike proizlaze iz predviđene učinkovitosti proizvoda u normalnim uvjetima uporabe.
the risks of accidental ingress of substances into the device;
ZAHTJEVI U VEZI S UČINKOVITOŠĆU, PROJEKTIRANJEM I PROIZVODNJOM
the risk of incorrect identification of specimens and the risk of erroneous results due to, for example, confusing colour and/or numeric and/or character codings on specimen receptacles, removable parts and/or accessories used with devices in order to perform the test or assay as intended;
Svojstva učinkovitosti
the risks of any foreseeable interference with other devices.
Proizvodi su projektirani i proizvedeni tako da budu prikladni za svrhe iz članka 2. točke 2., kako je naveo proizvođač, te da budu prikladni u pogledu učinkovitosti koju imaju namjeru postići imajući u vidu općepriznata najnovija dostignuća.
Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition.
Oni ostvaruju učinkovitost koju je naveo proizvođač, a posebice, ako je to primjenjivo:
Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion.
analitičku učinkovitost, kao što su osjetljivost analitičkog postupka, analitička specifičnost, istinitost (sustavno odstupanje), preciznost (ponovljivost i reproducibilnost), točnost (koja proizlazi iz istinitosti i preciznosti), granice otkrivanja i kvantitativnog određivanja, mjerni raspon, linearnost, granična vrijednost, uključujući određivanje odgovarajućih kriterija za prikupljanje uzoraka te postupanje s poznatim relevantnim endogenim i egzogenim interferencijama i križnim reakcijama te nadzor nad njima; i
Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
kliničku učinkovitost, kao što su dijagnostička osjetljivost, dijagnostička specifičnost, pozitivna prediktivna vrijednost, negativna prediktivna vrijednost, omjer vjerojatnosti, očekivane vrijednosti kod normalne i pogođene populacije.
Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
Svojstva učinkovitosti proizvoda održavaju se tijekom životnog vijeka proizvoda koji je naveo proizvođač.
Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by users, or other person.
Svojstva i učinkovitost proizvoda posebno se provjeravaju u slučaju da su podložna utjecaju kada se proizvodom koristi za predviđenu uporabu u normalnim uvjetima:
To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use.
za proizvode za samotestiranje, učinkovitost koju postižu laici;
Such procedures shall be described in the instructions for use.
za proizvode za testiranje u blizini pacijenta, učinkovitost koja se postiže u odgovarajućim okruženjima (primjerice, pacijentov dom, jedinice hitne pomoći, bolnička kola).
The measuring, monitoring or display scale (including colour change and other visual indicators) shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.
Kemijske, fizikalne i biološke značajke
Devices with a measuring function
Proizvodi su projektirani i proizvedeni tako da se osigura da su svojstva i zahtjevi za učinkovitosti iz poglavlja I postignuti.
Devices having a primary analytical measuring function shall be designed and manufactured in such a way as to provide appropriate analytical performance in accordance with point (a) of Section 9.1 of Annex I, taking into account the intended purpose of the device.
Posebna se pozornost posvećuje mogućnosti slabljenja analitičke učinkovitosti uslijed fizikalne i/ili kemijske nekompatibilnosti upotrijebljenih materijala i uzoraka, analita ili pokazatelja koji treba otkriti (poput bioloških tkiva, stanica, tjelesnih tekućina i mikroorganizama), vodeći računa o namjeni proizvoda.
The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC [3].15.
Proizvodi su projektirani, proizvedeni i pakirani tako da se na najmanju moguću mjeru svede rizik koji kontaminanti i ostaci predstavljaju za pacijente, vodeći računa o namjeni proizvoda, te za osobe koje sudjeluju u prijevozu, skladištenju i uporabi proizvoda.
Protection against radiation
Posebna pozornost pridaje se tkivima izloženim tim kontaminantima i ostacima te trajanju i učestalosti izloženosti.
Devices shall be designed, manufactured and packaged in such a way that exposure of users or other persons to radiation (intended, unintended, stray or scattered) is reduced as far as possible and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for diagnostic purposes.
Proizvodi su projektirani i proizvedeni tako da se svedu na najmanju razumno izvedivu mjeru rizici koje predstavljaju tvari ili čestice, uključujući čestice nastale trošenjem materijala, tvari nastale propadanjem i ostatke obrade, koje proizvod može otpuštati.
When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall as far as possible be:
Posebna pozornost pridaje se tvarima koje su kancerogene, mutagene ili reproduktivno toksične („CMR”), u skladu s dijelom 3.
designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted; and
Priloga VI.
fitted with visual displays and/or audible warnings of such emissions.
Uredbi (EZ) br. 1272/2008 Europskog parlamenta i Vijeća [1], te tvarima koje imaju svojstva endokrinih disruptora za koje ne postoje znanstveni dokazi o vjerojatnom ozbiljnom djelovanju na ljudsko zdravlje i koje su određene u skladu s postupkom utvrđenim u članku 59.
The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate.
Uredbe (EZ) br. 1907/2006 Europskog parlamenta i Vijeća [2].10.4.
Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified.
Proizvodi su projektirani i proizvedeni tako da se na najmanju moguću mjeru svedu rizici od nehotičnog prodora tvari u proizvod, vodeći računa o proizvodu i prirodi okruženja u kojem se namjerava upotrebljavati.
Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
Infekcije i mikrobna kontaminacija
Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use.
Proizvodi i njihovi proizvodni postupci projektirani su tako da se uklanja ili svede na najmanju moguću mjeru rizik od infekcije korisnika ili, ako je to primjenjivo, drugih osoba.
In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance.
Projektiranjem se:
For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.
omogućuje lagano i sigurno rukovanje;
Software referred to in this Section that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise).
svodi na najmanju moguću mjeru svako istjecanje mikroba iz proizvoda i/ili izloženost mikrobima tijekom uporabe;
Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
i, kada je potrebno,
Devices connected to or equipped with an energy source
sprječava mikrobna kontaminacija proizvoda tijekom uporabe, a u slučaju posuda za uzorke, rizik kontaminacije uzorka.
For devices connected to or equipped with an energy source, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
Proizvodi označeni ili kao sterilni ili specifičnog mikrobnog stanja projektirani su, proizvedeni i pakirani kako bi se osiguralo da se održi njihova sterilnost ili mikrobno stanje u uvjetima prijevoza i skladištenja koje navodi proizvođač, sve dok se to pakiranje ne otvori prilikom uporabe, osim ako je pakiranje koje održava njihovu sterilnost ili mikrobno stanje oštećeno.
Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical.
Proizvodi označeni kao sterilni moraju biti obrađeni, proizvedeni, pakirani i sterilizirani putem odgovarajućih provjerenih metoda.
If necessary, such warning or indication shall be given prior to the power supply becoming critical.
Proizvodi namijenjeni za sterilizaciju proizvode se i pakiraju u odgovarajućim i kontroliranim uvjetima i prostorima.
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment.
Sustavima pakiranja nesterilnih proizvoda održavaju se integritet i čistoća proizvoda i, ako se proizvodi trebaju sterilizirati prije uporabe, svodi na najmanju moguću mjeru rizik od mikrobne kontaminacije; sustav pakiranja prikladan je, uzimajući u obzir metodu sterilizacije koju navodi proizvođač.