natgillin/translations-raw huggingface dataset:
XV Correlation table
odpravljajo ali nadzorujejo tveganja iz točke (c) v skladu z zahtevami iz oddelka 4;
ANNEX I
ovrednotijo vpliv informacij, pridobljenih v fazi proizvodnje, in zlasti pa iz sistema nadzora po dajanju na trg, o nevarnostih in pogostosti njihovega pojavljanja, ocenah z njimi povezanih tveganj ter o splošnih tveganjih, razmerju med koristmi in tveganji in sprejemljivosti tveganj; in
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
po potrebi na podlagi ocene učinka informacij iz točke (e) spremenijo ukrepe nadzora v skladu z zahtevami iz oddelka 4.
GENERAL REQUIREMENTS
Ukrepi za nadzor nad tveganji, ki so jih proizvajalci sprejeli pri snovanju in izdelavi pripomočkov, so skladni z varnostnimi načeli, ob upoštevanju splošno priznanega zadnjega stanja tehničnega razvoja.
They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.
Proizvajalci pri izbiri najustreznejših rešitev po naslednjem prednostnem vrstnem redu:
The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.
z varno zasnovo in izdelavo odpravijo ali kar najbolj zmanjšajo tveganja;
Manufacturers shall establish, implement, document and maintain a risk management system.
kadar je to ustrezno, sprejmejo ustrezne zaščitne ukrepe, po potrebi tudi alarme, v zvezi s tveganji, ki jih ni mogoče odpraviti, in
Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.
predložijo informacije v zvezi z varnostjo (opozorila/ukrepi/kontraindikacije) in po potrebi zagotovijo usposabljanja za uporabnike.
In carrying out risk management manufacturers shall:
Proizvajalci uporabnike obvestijo o preostalih tveganjih.
establish and document a risk management plan for each device;
Za odpravo ali zmanjšanje tveganj, povezanih z napako pri uporabi, proizvajalec:
identify and analyse the known and foreseeable hazards associated with each device;
čim večje zmanjša tveganja, povezana z ergonomskimi značilnostmi pripomočka in okoljem, v katerem naj bi se pripomoček uporabljal (zasnova za varnost pacientov), in
estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
upošteva tehnično znanje, izkušnje, izobrazbo, usposobljenost, kraj uporabe, kadar je to ustrezno, ter medicinsko in fizično stanje predvidenih uporabnikov (zasnova za nestrokovne, strokovne, invalidne ali druge uporabnike).
eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
Vpliv na lastnosti in učinkovitost pripomočka ne sme biti škodljiv do tolikšne mere, da bi bilo med življenjsko dobo pripomočka, kot jo je določil proizvajalec, in ko je pripomoček izpostavljen obremenitvam, ki se lahko pojavijo pri običajnih pogojih uporabe, ter je ustrezno vzdrževan v skladu z navodili proizvajalca, ogroženo zdravje ali varnost pacienta ali uporabnika in, kadar je to ustrezno, drugih oseb.
evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, the benefit-risk ratio and risk acceptability; and
Pripomočki so zasnovani, izdelani in pakirani tako, da prevoz in skladiščenje, ob upoštevanju navodil in informacij proizvajalca, ne vplivata škodljivo – na primer zaradi nihanja temperature in vlažnosti – na njihove lastnosti in učinkovitost med predvideno uporabo.
based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4.
Vsa znana in predvidljiva tveganja ter neželeni učinki se čim bolj zmanjšajo in so sprejemljivi glede na ocenjene morebitne koristi za pacienta in/ali uporabnika iz predvidene učinkovitosti pripomočka pri običajnih pogojih uporabe.
Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art.
ZAHTEVE GLEDE UČINKOVITOSTI, ZASNOVE IN IZDELAVE
To reduce risks, the manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable.
Značilnosti učinkovitosti
In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
Pripomočki so zasnovani in izdelani tako, da so ustrezni za namene iz točke (2) člena 2, kot jih je navedel proizvajalec, in ustrezni glede na učinkovitost, ki se namerava z njimi doseči, ob upoštevanju splošno priznanega zadnjega stanja tehničnega razvoja.
eliminate or reduce risks as far as possible through safe design and manufacture;
So tako učinkoviti, kot zagotavlja proizvajalec, zlasti pa dosegajo, kjer je to ustrezno:
where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
analitsko učinkovitost, na primer analitsko občutljivost, analitsko specifičnost, pravilnost (izkrivljenost podatkov), natančnost (ponovljivost in obnovljivost), točnost (ki izhaja iz pravilnosti in natančnosti), meje zaznavanja in določanja, obseg meritev, linearnost, mejno vrednost, vključno z opredeljevanjem ustreznih meril za odvzem vzorcev in ravnanje z njimi ter nadzor znanih relevantnih endogenih in eksogenih interferenc, navzkrižne reakcije in
provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
klinično učinkovitost, na primer diagnostično občutljivost, diagnostično specifičnost, pozitivno napovedno vrednost, negativno napovedno vrednost, verjetnostno razmerje ter pričakovane vrednosti pri normalni in prizadeti populaciji.
Manufacturers shall inform users of any residual risks.
Značilnosti učinkovitosti pripomočka se ohranjajo med življenjsko dobo pripomočka, kot jo je določil proizvajalec.
In eliminating or reducing risks related to use error, the manufacturer shall:
Lastnosti in učinkovitost pripomočka se posebej preverijo, če se nanje lahko vpliva med predvideno uporabo pripomočka pod običajnimi pogoji:
reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
pri pripomočkih za samotestiranje: učinkovitost, ki jo dosežejo nestrokovnjaki;
give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
pri pripomočkih za testiranje ob pacientu: učinkovitost, doseženo v zadevnih okoljih (na primer na domu pacienta, v urgentnih enotah, reševalnih vozilih).
The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
Kemične, fizikalne in biološke lastnosti
Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.
Pripomočki so zasnovani in izdelani tako, da zagotavljajo izpolnjevanje zahteve glede lastnosti in učinkovitost iz poglavja I.
All known and foreseeable risks, and any undesirable effects shall be minimised and be acceptable when weighed against the evaluated potential benefits to the patients and/or the user arising from the intended performance of the device during normal conditions of use.
Posebna pozornost se nameni možnosti poslabšanja analitske učinkovitosti zaradi fizikalne in/ali kemične nekompatibilnosti med uporabljenimi materiali in vzorci, analitom ali označevalcem, ki ga je treba odkriti (kot so biološka tkiva, celice, telesne tekočine in mikroorganizmi), ob upoštevanju predvidenega namena pripomočka.
REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
Pripomočki so zasnovani, izdelani in pakirani tako, da se za paciente, ob upoštevanju predvidenega namena pripomočka, in za osebe, ki sodelujejo pri prevozu, skladiščenju in uporabi pripomočka, zmanjša tveganje zaradi kontaminantov in ostankov.
Performance characteristics
Posebna pozornost se nameni tkivom, izpostavljenim tem kontaminantom in ostankom, ter trajanju in pogostosti izpostavljenosti.
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.
Pripomočki so zasnovani in izdelani tako, da se tveganja zaradi snovi ali delcev, vključno z obrabnimi delci, razgradnimi produkti in ostanki iz proizvodnje, ki se lahko sprostijo iz pripomočka, zmanjšajo na smiselno izvedljivo raven.
They shall achieve the performances, as stated by the manufacturer and in particular, where applicable:
Posebna pozornost se nameni snovem, ki so rakotvorne, mutagene ali strupene za razmnoževanje, v skladu z delom 3 Priloge VI k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta [1], in snovem, ki so po svojih lastnostih endokrini motilci, za katere ni znanstvenih dokazov o verjetnih resnih posledicah za zdravje ljudi in ki so opredeljeni v skladu s postopkom iz člena 59 Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [2].10.4.
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
Pripomočki so zasnovani in izdelani tako, da se v kar največji meri zmanjšajo tveganja zaradi nenamernega prodiranja snovi v pripomoček, ob upoštevanju pripomočka in narave okolja, v katerem naj bi se uporabljal.
the clinical performance, such as diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations.
Okužba in kontaminacija z mikrobi
The performance characteristics of the device shall be maintained during the lifetime of the device as indicated by the manufacturer.
Pripomočki in postopki njihove izdelave so zasnovani tako, da se prepreči ali kar najbolj zmanjša možnost okužbe uporabnikov ali, kjer je to ustrezno, drugih oseb.
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.
Zasnova:
Where available, metrological traceability of values assigned to calibrators and control materials shall be assured to certified reference materials or reference measurement procedures.
omogoča preprosto in varno ravnanje;
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:
kolikor je mogoče zmanjša morebitno uhajanje mikrobov iz pripomočka in/ali izpostavljenost mikrobom med uporabo
for devices for self-testing, performances obtained by laypersons;
ter po potrebi
for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances).
preprečuje kontaminacijo pripomočka z mikrobi med uporabo, v primeru posod za vzorce pa tveganje kontaminacije vzorca.
Chemical, physical and biological properties
Pripomočki, označeni kot sterilni ali kot pripomočki s posebnim mikrobnim statusom, so zasnovani, izdelani in pakirani tako, da se zagotovi ohranitev njihove sterilnosti ali mikrobnega status pod pogoji prevoza in skladiščenja, ki jih opredeli proizvajalec, dokler se embalaža ob uporabi ne odpre, razen ob poškodbi embalaže, ki ohranja njihovo sterilno stanje ali mikrobni status.
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.
Pripomočki, označeni kot sterilni, so obdelani, izdelani, pakirani in sterilizirani z uporabo ustreznih potrjenih metod.
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.
Pripomočki, predvideni za sterilizacijo, so izdelani in pakirani v ustreznih in nadzorovanih razmerah in obratih.
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.
Sistemi pakiranja za nesterilne pripomočke ohranjajo neokrnjenost in čistočo izdelka ter, če je treba pripomočke pred uporabo sterilizirati, zmanjšujejo tveganje za kontaminacijo z mikrobi.
Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.
Sistem pakiranja je ustrezen ob upoštevanju metode sterilizacije, ki jo je določil proizvajalec.
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.
Pri označevanju pripomočka se razlikuje med enakimi ali podobnimi pripomočki, ki se dajejo na trg v sterilnem in nesterilnem stanju, poleg simbola, ki označuje, da so pripomočki sterilni.
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.
Pripomočki, ki vsebujejo materiale biološkega izvora
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.
Kadar pripomočki vsebujejo tkiva, celice in snovi živalskega, človeškega ali mikrobnega izvora, se izbira virov, obdelava, konzerviranje, testiranje in ravnanje s tkivi, celicami in snovmi takšnega izvora ter postopki nadzora opravijo tako, da se zagotovi varnost za uporabnika ali drugo osebo.
Infection and microbial contamination
Še zlasti se z izvajanjem potrjenih metod uničevanja ali inaktivacije med proizvodnim postopkom zagotovi varnost pred mikrobi in drugimi prenosljivimi povzročitelji.
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.
To ne velja za nekatere pripomočke, če je delovanje mikroba in drugega prenosljivega povzročitelja del predvidenega namena pripomočka ali ko bi takšen proces uničenja ali inaktivacije ogrozil učinkovitost pripomočka.
The design shall:
Zgradba pripomočkov in interakcija z njihovim okoljem
allow easy and safe handling;
Če je pripomoček predviden za uporabo v kombinaciji z drugimi pripomočki ali opremo, je celotna kombinacija, vključno s priključnim sistemom, varna in ne vpliva na navedeno učinkovitost pripomočkov.
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use;
Morebitne omejitve uporabe, ki veljajo za take kombinacije, so navedene na oznaki in/ali v navodilih za uporabo.
and, where necessary
Pripomočki so zasnovani in izdelani tako, da se v čim večji meri preprečijo ali zmanjšajo:
prevent microbial contamination of the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen.
tveganje za poškodbe zaradi fizikalnih lastnosti, vključno z razmerjem prostornina/pritisk, razsežnostnih in, kadar je to ustrezno, ergonomskih lastnosti pripomočkov;
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.
tveganja, povezana z razumno predvidljivimi zunanjimi vplivi ali okoljskimi razmerami, kot so magnetna polja, zunanji električni in elektromagnetni učinki, elektrostatična razelektritev, sevanje, povezano z diagnostičnimi ali terapevtskimi postopki, pritisk, vlažnost, temperatura, nihanje tlaka in pospeška ali motnje radijskih signalov;
Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods.
tveganja, povezana z uporabo pripomočka pri stiku z materiali, tekočinami in snovmi, vključno s plini, ki jim je izpostavljen pri običajnih pogojih uporabe;
Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities.
tveganja, povezana z morebitno negativno interakcijo med programsko opremo in informacijskim okoljem, v katerem deluje in se povezuje;
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.
tveganja za naključno prodiranje snovi v pripomoček;
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.
tveganje za nepravilno identifikacijo vzorcev in tveganje za napačne rezultate, na primer zaradi zavajajoče barve in/ali številčnih in/ali znakovnih kod na posodah za vzorce, odstranljivih delih in/ali dodatkih, ki se uporabljajo s pripomočki, da bi izvedli preskus ali test, kot je bilo predvideno;
Devices incorporating materials of biological origin
tveganja kakršnih koli predvidljivih motenj z drugimi pripomočki.
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.
Pripomočki so zasnovani in izdelani tako, da se zmanjšajo tveganja za požar ali eksplozijo pri običajni uporabi in v primeru ene same napake.
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.
Posebna pozornost se nameni pripomočkom, katerih predvidena uporaba vključuje izpostavljenost vnetljivim ali eksplozivnim snovem ali snovem, ki bi lahko povzročile gorenje, ali uporabo v povezavi s takimi snovmi.
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.
Pripomočki so zasnovani in izdelani tako, da se lahko varno in učinkovito prilagajajo, kalibrirajo in vzdržujejo.
Construction of devices and interaction with their environment
Pripomočki, ki so namenjeni za uporabo skupaj z drugimi pripomočki ali izdelki, so zasnovani in izdelani tako, da sta interoperabilnost in kompatibilnost zanesljivi in varni.
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.
Pripomočki so zasnovani in izdelani tako, da se uporabniku ali drugi osebi olajša varno odstranjevanje pripomočka in pripadajočih odpadnih snovi.
Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use.
V ta namen proizvajalci določijo in preskušajo postopke in ukrepe, s katerimi se lahko njihovi pripomočki po uporabi varno odstranijo.
Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
Ti postopki se opišejo v navodilih za uporabo.
the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features;
Meritve, nadzor ali prikaz podatkov (vključno s kazalniki spremembe barve ali drugimi vizualnimi kazalniki) so zasnovani in izdelani v skladu z ergonomskimi načeli, ob upoštevanju predvidenega namena, uporabnikov in okoljskih pogojev, v katerih se pripomočki nameravajo uporabljati.
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;
Pripomočki z merilno funkcijo
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;
Pripomočki, ki imajo predvsem analitično merilno funkcijo, so zasnovani in izdelani tako, da zagotavljajo ustrezno analitsko učinkovitost v skladu s točko (a) oddelka 9.1 Priloge I ter ob upoštevanju predvidenega namena pripomočka.
the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts;
Merjenja, ki se opravljajo s pripomočki z merilno funkcijo, so izražena v zakonitih enotah v skladu z določbami Direktive Sveta 80/181/EGS [3].15.
the risks of accidental ingress of substances into the device;
Zaščita pred sevanjem