natgillin/translations-raw huggingface dataset:
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, benefit-risk ratio and risk acceptability; and
ocenijo in ovrednotijo tveganja, ki so povezana z predvideno uporabo ali razumno predvidljivo nepravilno uporabo in se pojavijo ob njej;
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.
odpravljajo ali nadzorujejo tveganja iz točke (c) v skladu z zahtevami iz oddelka 4;
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.
ovrednotijo vpliv informacij iz faze proizvodnje, 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 tveganja; ter
To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable.
po potrebi na podlagi ocene učinka informacij iz točke (e) spremenijo ukrepe nadzora v skladu z zahtevami iz oddelka 4.
In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
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.
eliminate or reduce risks as far as possible through safe design and manufacture;
Da bi se tveganja zmanjšala, jih proizvajalci obvladujejo tako, da se preostalo tveganje, povezano z vsako posamezno nevarnostjo, in skupno preostalo tveganje ocenita kot sprejemljiva.
where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
Proizvajalci pri izbiri najustreznejših rešitev sledijo naslednjemu prednostnemu vrstnemu redu:
provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
z varno zasnovo in izdelavo odpraviti tveganja ali jih kar najbolj zmanjšati;
Manufacturers shall inform users of any residual risks.
kadar je to ustrezno, sprejeti ustrezne zaščitne ukrepe, po potrebi tudi uvesti alarmne sisteme, v zvezi s tveganji, ki jih ni mogoče odpraviti, in
In eliminating or reducing risks related to use error, the manufacturer shall:
predložiti informacije v zvezi z varnostjo (opozorila/ukrepi/kontraindikacije) in po potrebi zagotoviti usposabljanja za uporabnike.
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
Proizvajalci uporabnike obvestijo o preostalih tveganjih.
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).
Za odpravo ali zmanjšanje tveganj, povezanih z napako pri uporabi, proizvajalec:
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.
čim bolj zmanjša tveganja, povezana z ergonomskimi značilnostmi pripomočka in okolja, v katerem naj bi se pripomoček uporabljal (zasnova za varstvo pacientov), in
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.
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).
All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.
Vpliv na lastnosti in učinkovitost pripomočka ne sme biti škodljiv do tolikšne mere, da bi bilo ogroženo zdravje ali varnost pacienta ali uporabnika in, kadar je to ustrezno, drugih oseb, med življenjsko dobo pripomočka, kot jo določi proizvajalec, in ko je pripomoček izpostavljen obremenitvam, ki se lahko pojavijo pri običajnih pogojih uporabe, ter je ustrezno vzdrževan v skladu z navodili proizvajalca.
For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons.
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.
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
Vsa znana in predvidljiva tveganja ter morebitni neželeni stranski učinki se kar najbolj zmanjšajo in so sprejemljivi glede na ocenjene koristi za pacienta in/ali uporabnika, ki izhajajo iz dosežene učinkovitosti pripomočka pri običajnih pogojih uporabe.
Chemical, physical and biological properties
Za pripomočke iz Priloge XVI se v zvezi s splošnimi zahtevami glede varnosti iz oddelkov 1 in 8 razume, da pripomoček, ko se uporablja v skladu s predvidenimi pogoji in za predvidene namene, ne pomeni nobenega tveganja oziroma ne pomeni večjega tveganja, kot bi v skladu z visoko ravnjo varovanja zdravja in varnosti oseb bilo pri uporabi pripomočka še sprejemljivo.
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.
ZAHTEVE V ZVEZI Z ZASNOVO IN IZDELAVO
Particular attention shall be paid to:
Kemične, fizikalne in biološke lastnosti
the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;
Pripomočki so zasnovani in izdelani tako, da je zagotovljeno izpolnjevanje zahtev glede lastnosti in učinkovitost iz poglavja I. Posebna pozornost je namenjena:
the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;
izbiri uporabljenih materialov in snovi, zlasti kar zadeva strupenost in, kjer je to ustrezno, vnetljivost;
the compatibility between the different parts of a device which consists of more than one implantable part;
kompatibilnosti med uporabljenimi materiali in snovmi, uporabljenimi v bioloških tkivih, celicah in telesnih tekočinah, ob upoštevanju predvidenega namena pripomočka in, kadar je to ustrezno, absorpcije, porazdelitve, metabolizma in izločanja;
the impact of processes on material properties;
kompatibilnosti različnih delov pripomočka, ki sestoji iz več kot enega dela za vsaditev;
where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;
vplivu procesov na lastnosti materiala;
surface properties; and
mehanskim lastnostim uporabljenih materialov, ki po potrebi odražajo vidike, kot so trdnost, razteznost, prelomna trdnost, odpornost proti obrabi in odpornost proti utrujanju;
the confirmation that the device meets any defined chemical and/or physical specifications.
površinskim lastnostim in
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.
potrditvi, da pripomoček izpolnjuje vse opredeljene kemične in/ali fizikalne specifikacije.
Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.
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.
Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products and that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use.
Pri tem se posebna pozornost nameni tkivom, izpostavljenim tem kontaminantom in ostankom, ter trajanju in pogostosti izpostavljenosti.
Substances
Pripomočki so zasnovani in izdelani tako, da jih je mogoče varno uporabljati z materiali in snovmi, vključno s plini, s katerimi pridejo v stik pri njihovi predvideni uporabi; če so pripomočki namenjeni dajanju zdravil, so zasnovani in izdelani tako, da so združljivi z zadevnimi zdravili v skladu z določbami in omejitvami, ki veljajo za ta zdravila, ter da se učinkovitost zdravil in pripomočkov vzdržuje v skladu s njihovimi ustreznimi indikacijami in predvideno uporabo.
Design and manufacture of devices
Snovi
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.
Zasnova in izdelava pripomočkov
Devices, or those parts thereof or those materials used therein that:
Pripomočki so zasnovani in izdelani tako, da se, kolikor je mogoče, zmanjšajo tveganja zaradi snovi ali delcev, vključno z obrabnimi delci, razgradnimi produkti in ostanki iz proizvodnje, ki se lahko sprostijo iz pripomočka.
are invasive and come into direct contact with the human body,
Pripomočki, ali tisti deli pripomočkov ali tisti materiali, uporabljeni v pripomočkih, ki so:
(re)administer medicines, body liquids or other substances, including gases, to/from the body, or
invazivni in prihajajo v neposreden stik s človeškim telesom, ali
transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,
namenjeni (ponovnemu) dajanju zdravil in vnašanju telesnih tekočin ali drugih snovi, vključno s plini, na/v telo oz. odvajanju iz njega, ali
shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2:
namenjeni prevozu ali skladiščenju takih zdravil, telesnih tekočin ali snovi, vključno s plini, ki naj bi bili (ponovno) dani na/v telo,
substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council [1], or
smejo vsebovati naslednje snovi v koncentraciji, ki presega 0,1 mas. %, le če je to utemeljeno v skladu z oddelkom 10.4.2.:
substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either 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] or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council [3], in accordance with the criteria that are relevant to human health amongst the criteria established therein.
snovi kategorije 1A ali 1B, ki so rakotvorne, mutagene ali strupene za razmnoževanje (v nadaljnjem besedilu: snovi CMR), v skladu z delom 3 Priloge VI k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta [1], ali
Justification regarding the presence of CMR and/or endocrine-disrupting substances
snovi, ki so po svojih lastnostih endokrini motilci, za katere obstajajo znanstveni dokazi o verjetnih resnih posledicah za zdravje ljudi, in ki so opredeljene bodisi v skladu s postopkom iz člena 59 Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [2] bodisi v skladu z merili, ki se nanašajo na zdravje ljudi in so skupaj z drugimi merili določena v delegiranih aktih, ki jih sprejme Komisija v skladu s prvim pododstavkom člena 5(3) Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta [3].
The justification for the presence of such substances shall be based upon:
Utemeljitev prisotnosti snovi CMR in/ali endokrinih motilcev
an analysis and estimation of potential patient or user exposure to the substance;
Prisotnost snovi CMR in/ali endokrinih motilcev se utemelji:
an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives;
z analizo in oceno morebitne izpostavljenosti pacienta ali uporabnika snovi;
argumentation as to why possible substance and/ or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including taking into account if the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials; and
z analizo morebitnih alternativnih snovi, materialov ali zasnov, vključno z morebitnimi informacijami o neodvisnih raziskavah, strokovno pregledanimi študijami in znanstvenimi mnenji ustreznih znanstvenih odborov, in analizo razpoložljivosti takih alternativ;
where applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4.
z razlago, zakaj uporaba morebitne nadomestne snovi in/ali materiala, če sta na voljo, ali sprememba zasnove, če bi bila mogoča, nista ustrezni za ohranitev funkcionalnosti, zmogljivosti in razmerja med koristmi in tveganji izdelka; upošteva se tudi, ali je uporaba takšnih pripomočkov predvidena tudi za zdravljenje otrok, nosečnic ali doječih mater ali za zdravljenje drugih skupin pacientov, za katere velja, da jih takšne snovi in/ali materiali še posebno ogrožajo, in
Guidelines on phthalates
po potrebi z najnovejšimi zadevnimi smernicami znanstvenega odbora v skladu z oddelkoma 10.4.3. in 10.4.4, če so na voljo.
For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020.
Smernice glede ftalatov
The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1.
Pri oceni razmerja med koristmi in tveganjem upošteva predvideni namen pripomočka in okoliščine, v katerih se uporablja, ter vse razpoložljive alternativne snovi in alternativne materiale, zasnove ali zdravljenja.
The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments.
Smernice se posodobijo, ko je na podlagi najnovejših znanstvenih dokazov to potrebno, vendar najmanj vsakih pet let.
When deemed appropriate on the basis of the latest scientific evidence, but at least every five years, the guidelines shall be updated.
Smernice glede drugih snovi CMR in endokrinih motilcev
Guidelines on other CMR and endocrine-disrupting substances
Komisija nadalje po potrebi pooblasti ustrezni znanstveni odbor za pripravo smernic iz oddelka 10.4.3. tudi glede drugih snovi iz točk (a) in (b) oddelka 10.4.1.
Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1., where appropriate.
Označevanje
Labelling
Če – kot je navedeno v oddelku 10.4.1. – pripomočki, deli pripomočkov ali materiali, uporabljeni v pripomočkih, vsebujejo snovi iz točk (a) in (b) oddelka 10.4.1. v koncentraciji, višji od 0,1 mas. %, se vsebnost teh snovi navede na pripomočku samem in/ali embalaži vsake enote ali po potrebi prodajni embalaži, skupaj s seznamom takšnih snovi.
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
Če je uporaba takšnih pripomočkov predvidena tudi za zdravljenje otrok, nosečnic ali doječih mater ali za zdravljenje drugih skupin pacientov, za katere velja, da jih takšne snovi/materiali še posebno ogrožajo, se v navodilih za uporabo navedejo informacije o preostalih tveganjih za te skupine pacientov in po potrebi o ustreznih previdnostnih ukrepih.
If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
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.
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.
Pripomočki so zasnovani in izdelani tako, da se v kar največji možni meri zmanjšajo tveganja, povezana z velikostjo in lastnostmi uporabljenih delcev, ki se sprostijo ali bi se lahko sprostili v telo pacienta ali uporabnika, razen če pridejo v stik samo z nepoškodovano kožo.
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patient's or user's body, unless they come into contact with intact skin only.
Posebna pozornost se nameni nanomaterialom.
Special attention shall be given to nanomaterials.
Okužba in kontaminacija z mikrobi
Infection and microbial contamination
Pripomočki in postopki njihove izdelave so zasnovani tako, da se prepreči ali v kar največji možni meri zmanjša možnost okužbe pacientov, uporabnikov in, kjer je to ustrezno, drugih oseb.
Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons.
Zasnova:
The design shall:
zmanjšuje, kolikor je to mogoče in ustrezno, nevarnost nenamernih ureznin in vbodov, npr. poškodb z injekcijsko iglo;
reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,
omogoča preprosto in varno ravnanje;
allow easy and safe handling,
zmanjšuje, kolikor je to mogoče, morebitno uhajanje mikrobov iz pripomočka in/ali izpostavljenost mikrobom med uporabo in
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and
preprečuje kontaminacijo pripomočka ali njegove vsebine, kot so vzorci ali tekočine, z mikrobi.
prevent microbial contamination of the device or its content such as specimens or fluids.
Pripomočki so po potrebi zasnovani tako, da se olajša njihovo varno čiščenje, razkuževanje in/ali ponovna sterilizacija.
Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.
Pripomočki, označeni kot pripomočki s posebnim mikrobnim statusom, so zasnovani, izdelani in pakirani tako, da bodo taki tudi ostali, ko bodo dani na trg, in bodo taki ostali pod pogoji prevoza in skladiščenja, ki jih opredeli proizvajalec.
Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer.
Pripomočki, dostavljeni v sterilnem stanju, so zasnovani, izdelani in pakirani v skladu z ustreznimi postopki, da se zagotovi njihova sterilnost, ko so dani na trg, ter da – razen ob poškodbi embalaže, ki je namenjena ohranjanju njihove sterilnosti – pod pogoji prevoza in skladiščenja, ki jih določi proizvajalec, ostanejo sterilni, dokler ni ta embalaža odprta ob trenutku uporabe.
Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use.
Zagotovi se, da je neoporečnost te embalaže jasno razvidna za končnega uporabnika.
It shall be ensured that the integrity of that packaging is clearly evident to the final user.
Pripomočki, označeni kot sterilni pripomočki, so obdelani, izdelani, pakirani in sterilizirani z uporabo ustreznih potrjenih metod.
Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods.
Pripomočki, predvideni za sterilizacijo, so izdelani in pakirani v ustreznih in nadzorovanih razmerah in obratih.
Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities.
Sistemi pakiranja za nesterilne pripomočke ohranjajo neokrnjenost in čistočo izdelka ter, če je treba pripomočke pred uporabo sterilizirati, zmanjšujejo tveganje za kontaminacijo z mikrobi.
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.
Sistem pakiranja je ustrezen ob upoštevanju metode sterilizacije, ki jo je določil proizvajalec.