natgillin/translations-raw huggingface dataset:
RISK ANALYSIS AND RISK MANAGEMENT
ANALIZA IN OBVLADOVANJE TVEGANJA
Justification for the use of animal tissues or derivatives
Utemeljitev uporabe živalskih tkiv ali derivatov
The manufacturer must justify, on the basis of his overall risk analysis and risk management strategy for a specific medical device, the decision to use animal tissues or derivatives, referred to in Article 1, (specifying animal species, tissues and sourcing) taking into account the clinical benefit, potential residual risk and suitable alternatives (such as lower risk tissues or synthetic alternatives).
Proizvajalec mora na podlagi svoje celovite strategije analize in obvladovanja tveganja za posamezne medicinske pripomočke utemeljiti odločitev za uporabo živalskih tkiv ali derivatov iz člena 1 (s podrobno navedbo živalskih vrst, tkiv in izvora), pri čemer upošteva klinično učinkovitost, morebitno preostalo tveganje in ustrezne alternative (npr. tkiva z nižjo stopnjo tveganja ali nadomestne sintetične materiale).
Process of risk assessment
Postopek ocenjevanja tveganja
In order to ensure a high level of protection for patients and users, the manufacturer of devices utilising animal tissues or derivatives referred to in point 1.1 must implement an appropriate and well documented risk analysis and risk management strategy, to address all relevant aspects relating to TSE.
Da se zagotovi visoka raven zaščite bolnikov in uporabnikov, mora proizvajalec pripomočkov, za katere se uporabljajo živalska tkiva ali derivati iz točke 1.1, izvajati ustrezno in dobro dokumentirano strategijo analize in obvladovanja tveganja za obravnavo vseh pomembnih vidikov, povezanih s TSE.
He must identify the hazards and evaluate the risks associated with those tissues or derivatives, establish documentation on measures taken to minimise the risk of transmission and demonstrate the acceptability of the residual risk associated with the device utilising such tissues or derivatives, taking into account the intended use and the benefit of the device.
Opredeliti mora nevarnosti in ovrednotiti tveganja, povezana z navedenimi tkivi ali derivati, dokumentirati ukrepe, sprejete za kar največje zmanjšanje tveganja prenosa, ter prikazati sprejemljivost preostalega tveganja v zvezi s pripomočkom, za katerega se uporabljajo taka tkiva ali derivati, pri čemer upošteva predvideno uporabo in učinkovitost pripomočka.
The safety of a device, in terms of its potential for passing on a TSE infectious agent, is dependent on all the factors described in sections 1.2.1 to 1.2.8, which the manufacturer must analyse, evaluate and manage.
Varnost pripomočka glede na njegov potencial za prenos povzročitelja okužbe s TSE je odvisna od vseh dejavnikov iz oddelkov 1.2.1 do 1.2.8, ki jih mora proizvajalec analizirati, oceniti in obvladovati.
These measures in combination determine the device safety.
Varnost pripomočka je odvisna od kombinacije teh ukrepov.
At a minimum, the manufacturer must consider the following key steps:
Proizvajalec mora upoštevati vsaj naslednje ključne postopke:
selecting starting materials (tissues or derivatives) considered appropriate regarding their potential contamination with TSE infectious agents (see 1.2.1, 1.2.2, 1.2.3 and 1.2.4) taking into account further collection, handling, transport, storage and processing;
izbor vhodnih materialov (tkiv ali derivatov), ki se štejejo za ustrezne glede na njihovo možno okužbo s povzročitelji okužbe s TSE (glej 1.2.1, 1.2.2, 1.2.3 in 1.2.4) ob upoštevanju nadaljnjega zbiranja, ravnanja, prevoza, skladiščenja in predelave;
applying a production process to remove or inactivate TSE infectious agents on controlled sourced tissues or derivatives (see 1.2.5);
uporabo proizvodnega postopka za odstranitev ali inaktivacijo povzročiteljev okužbe s TSE na nadzorovanih tkivih ali derivatih ugotovljenega izvora (glej 1.2.5);
maintaining a system to collect and evaluate production and post-production information regarding changes which may affect the assessment of the suitability of steps referred to in points (a) and (b).
vzdrževanje sistema za zbiranje in vrednotenje informacij iz obdobja proizvodnje in obdobja po proizvodnji v zvezi s spremembami, ki bi lahko vplivale na oceno ustreznosti postopkov iz točk (a) in (b).
Furthermore, the manufacturer must take into account the characteristics of the device and its intended use (see 1.2.6, 1.2.7 and 1.2.8).
Poleg tega mora proizvajalec upoštevati značilnosti pripomočka in njegovo predvideno uporabo (glej 1.2.6, 1.2.7 in 1.2.8).
In performing the risk analysis and risk management strategy, the manufacturer must give due consideration to the relevant published opinions adopted by the relevant European or international scientific committees or bodies, such as the Scientific Steering Committee (SSC), the European Food Safety Agency (EFSA), the European Medicines Agency (EMA), the World Organisation for Animal Health (OIE) and the World Health Organisation (WHO).
Pri izvajanju strategije analize in obvladovanja tveganja mora proizvajalec ustrezno upoštevati ustrezna objavljena mnenja, ki jih sprejmejo ustrezni evropski ali mednarodni znanstveni odbori ali organi, kot so Znanstveni pripravljalni odbor, Evropska agencija za varstvo hrane, Evropska agencija za zdravila, Svetovna organizacija za zdravje živali in Svetovna zdravstvena organizacija.
Animals as a source of material
Živali kot izvor materiala
The TSE risk is related to the source species, strains and nature of the starting tissue.
Tveganje za TSE je povezano z izvorno vrsto, sevom in naravo vhodnega tkiva.
As the accumulation of TSE infectivity occurs over an incubation period of several years, sourcing from young healthy animals is considered to be a factor reducing the risk.
Ker je inkubacijska doba za TSE več let, lahko uporaba materialov od mladih živali zmanjša tveganje.
Risk animals such as fallen stock, emergency slaughtered and TSE suspected animals must be excluded as a source of material.
Kot izvor materiala je treba izključiti rizične živali, kot so poginule živali, nujno zaklane živali in živali, za katere se sumi, da imajo TSE.
Geographical sourcing
Geografski izvor
The manufacturer must take into account the classification of the risks relating to different types of starting tissue as defined in the WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies (2006), as amended.
Proizvajalec mora upoštevati klasifikacijo tveganj glede na različne tipe vhodnega tkiva, kakor so opredeljeni v smernicah Svetovne zdravstvene organizacije o porazdelitvi nalezljivosti prenosnih spongiformnih encefalopatij v tkivih (WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies, 2006), kakor so bile spremenjene.
Sourcing of animal tissue must be performed in such a manner as to maintain control over the traceability and integrity of source tissue.
Izvor živalskega tkiva je treba izbrati tako, da se pri tem ohranja nadzor nad sledljivostjo in neoporečnostjo izvornega tkiva.
Where appropriate, the animals shall be subjected to veterinary ante- and post-mortem inspection.
Po potrebi je treba na živalih opraviti preglede ante mortem in post mortem.
In addition, Regulation (EC) No 1069/2009 applies.
Poleg tega se uporablja Uredba (ES) št. 1069/2009.
Without prejudice to the provision in the following paragraph, only category 3 material in accordance with Article 10 of Regulation (EC) No 1069/2009 shall be used.
Brez poseganja v določbe naslednjega odstavka se uporabljajo le snovi kategorije 3 v skladu s členom 10 Uredbe (ES) št. 1069/2009.
The manufacturer must not source animal tissue or derivatives classified as potentially high TSE infective, unless sourcing of these materials is necessary in exceptional circumstances, taking into account the important benefit for the patient and the absence of an alternative starting tissue.
Proizvajalec ne sme uporabiti živalskega tkiva ali derivatov, klasificiranih kot potencialno močno tveganih za okužbo s TSE, razen če ni uporaba teh snovi potrebna v izjemnih okoliščinah, ob upoštevanju pomembnih koristi za bolnika in neobstoja alternativnega vhodnega tkiva.
For bovine, ovine and caprine animals, the list of specified risk material (SRM) laid down in Annex V to Regulation (EC) No 999/2001 is to be considered as being potentially of high TSE infectivity.
V primeru goveda, ovc in koz je treba kot potencialno močno tvegane za okužbo s TSE šteti snovi s specifičnim tveganjem na seznamu iz Priloge V k Uredbi (ES) št. 999/2001.
Slaughtering and processing controls to prevent cross contamination
Nadzor pri klanju in predelavi za preprečevanje navzkrižne okužbe
The manufacturer must ensure that the risk of cross-contamination during slaughtering, collection, processing, handling, storage and transport is minimised.
Proizvajalec mora zagotoviti kar največje zmanjšanje tveganja navzkrižne okužbe pri klanju, zbiranju, predelavi, ravnanju, skladiščenju in prevozu.
Inactivation or removal of TSE infectious agents
Inaktivacija ali odstranitev povzročiteljev okužbe s TSE
For devices which cannot withstand an inactivation or elimination process without undergoing unacceptable degradation, the manufacturer must rely principally on the control of sourcing.
Pri pripomočkih, ki ne zdržijo postopka inaktivacije ali odprave brez nesprejemljive razgradnje, se mora proizvajalec večinoma opirati na nadzor izvora.
For other devices, if claims are made by the manufacturer for the ability of manufacturing processes to remove or inactivate TSE infectious agents, these must be substantiated by appropriate documentation.
Če proizvajalec za druge pripomočke trdi, da je mogoče povzročitelje okužbe s TSE odstraniti ali inaktivirati s proizvodnimi postopki, mora to utemeljiti z ustrezno dokumentacijo.
Relevant information from an analysis of appropriate scientific literature can be used to support inactivation and elimination factors, where the specific processes referred to in the literature are comparable to those used for the device.
Ustrezne informacije, pridobljene z analizo ustrezne znanstvene literature, se lahko uporabijo kot utemeljitev za dejavnike inaktivacije in odprave, če so posamezni postopki, pri katerih se uporabi sklic na literaturo, primerljivi s tistimi, ki se uporabijo za pripomoček.
This search and analysis shall also cover the available scientific opinions that may have been adopted by an European or international scientific committee or body.
Ta pregled in analiza morata vključevati tudi razpoložljiva znanstvena mnenja, ki jih je morda sprejel evropski ali mednarodni znanstveni odbor ali organ.
These opinions are to serve as a reference, in cases where there are conflicting opinions.
Ta mnenja služijo kot reference v primerih nasprotujočih si mnenj.
If the literature search fails to substantiate the claims, the manufacturer must set up a specific inactivation or elimination study, as appropriate, on a scientific basis and the following need to be considered:
Če trditve niso utemeljene s pregledom literature, mora proizvajalec izvesti posebno študijo inaktivacije ali odstranitve, kakor je primerno, na znanstveni podlagi, pri čemer je treba upoštevati naslednje:
the identified hazard associated with the tissue;
ugotovljeno nevarnost v zvezi s tkivom;
identification of the relevant model agents;
določitev ustreznih vzorčnih povzročiteljev;
rationale for the choice of the particular combinations of model agents;
razloge za izbiro določene kombinacije vzorčnih povzročiteljev;
identification of step and/or stage chosen to eliminate or inactivate the TSE infectious agents;
določitev postopka in/ali faze, izbrane za odpravo ali inaktivacijo povzročiteljev okužbe s TSE;
documentation of the parameters for any TSE inactivation or elimination validation study;
dokumentacijo parametrov za kakršno koli validacijsko študijo inaktivacije ali odprave TSE;
calculation of the reduction factors.
izračun faktorjev zmanjšanja.
The manufacturer must apply appropriate documented procedures to ensure that the validated processing parameters are applied during routine manufacture.
Proizvajalec mora uporabiti ustrezno dokumentirane postopke za zagotovitev, da se pri redni proizvodnji uporabljajo validirani parametri predelave.
A final report must identify manufacturing parameters and limits that are critical to the effectiveness of the inactivation or elimination process.
Končno poročilo mora opredeliti kritične proizvodne parametre in meje za učinkovitost postopka inaktivacije ali odprave.
Quantities of animal tissues or derivatives required to produce one unit of the medical device
Količine živalskih tkiv ali derivatov, potrebne za proizvodnjo ene enote medicinskega pripomočka
The manufacturer must evaluate the quantity of raw tissues or derivatives of animal origin required to produce a single unit of the medical device.
Proizvajalec mora ovrednotiti količino surovih tkiv ali derivatov živalskega izvora, potrebno za izdelavo ene enote medicinskega pripomočka.
The manufacturer must assess whether the production process has the potential to concentrate levels of TSE infectious agents present in the animal starting tissues or derivatives.
Proizvajalec mora oceniti, ali pri proizvodnem postopku obstajajo možnosti za koncentriranje stopenj povzročiteljev okužbe s TSE, prisotnih v živalskih vhodnih tkivih ali derivatih.
Tissues or derivatives of animal origin coming into contact with the patients and users
Tkiva ali derivati živalskega izvora, ki prihajajo v stik z bolniki in uporabniki
The manufacturer must consider:
Proizvajalec mora upoštevati:
the maximum quantity of animal tissues or derivatives coming into contact with the patient or user when using a single medical device;
največjo količino živalskih tkiv ali derivatov, ki pridejo v stik z bolnikom ali uporabnikom pri uporabi enega medicinskega pripomočka;
the contact area: its surface, type (e.g. skin, mucous tissue, brain) and condition (e.g. healthy or damaged);
stično območje: njegovo površino, vrsto (npr. koža, sluznica, možgani) in stanje (npr. zdravo ali poškodovano);
the type of the tissues or derivatives coming into contact with the patients or users;
vrsto tkiv ali derivatov, ki prihajajo v stik z bolniki ali uporabniki;
the period of time the device is intended to remain in contact with the body (including bioresorption effect); and
obdobje, za katero naj bi pripomoček ostal v stiku s telesom (vključno z bioresorpcijskim učinkom), ter
the number of medical devices that could be used in a given procedure or, if possible, over the lifetime of a patient or user.
število medicinskih pripomočkov, ki bi se lahko uporabili pri določenem postopku, če je mogoče, v celotnem življenjskem obdobju bolnika ali uporabnika.
In the risk assessment, the manufacturer must take into account the route of administration as indicated in the product information.
Pri oceni tveganja mora proizvajalec upoštevati način uporabe zdravila, kakor je naveden v informacijah o proizvodu.
Review of the risk assessment
Pregled ocene tveganja
The manufacturer must establish and maintain a systematic procedure to review information gained about the medical device or similar devices in the post-production phase.
Proizvajalec mora vzpostaviti in ohranjati sistematičen postopek za pregled informacij o medicinskem pripomočku ali podobnih pripomočkih, zbranih v obdobju po proizvodnji.
The information must be evaluated for possible relevance to safety, especially in any of the following cases:
Informacije je treba ovrednotiti glede možnega pomena za varnost, zlasti v katerem koli izmed naslednjih primerov:
previously unrecognised hazards are identified;
če se odkrijejo prej nepoznane nevarnosti;
the estimated risk arising from a hazard has changed or is no longer acceptable;
če se ocenjeno tveganje zaradi nevarnosti spremeni ali ni več sprejemljivo;
the original assessment is otherwise invalidated.
če je izvirna ocena razveljavljena na kak drug način.
In the cases set out in points (a), (b) or (c), the manufacturer shall feed back the results of the evaluation as an input to the risk management process.
V primerih iz točk (a), (b) ali (c) proizvajalec upošteva rezultate ocene pri postopku obvladovanja tveganja.
In the light of this new information, a review of the appropriate risk management measures for the device must be considered (including rationale for choosing an animal tissue or derivative).
Glede na te nove informacije je treba razmisliti o pregledu ustreznih ukrepov za obvladovanje tveganja za pripomoček (vključno z razlogi za izbiro živalskega tkiva ali derivata).
If there is a potential that the residual risk or its acceptability has changed, the impact on previously implemented risk control measures must be re-evaluated and justified.
Če obstaja možnost, da se je spremenilo preostalo tveganje ali njegova sprejemljivost, je treba ponovno ovrednotiti in utemeljiti vpliv na predhodno izvedene ukrepe za kontrolo tveganja.
The results of this evaluation must be documented.
Rezultate tega ovrednotenja je treba dokumentirati.
EVALUATION BY NOTIFIED BODIES
OVREDNOTENJE S STRANI PRIGLAŠENIH ORGANOV
For the medical devices referred to in Article 1(1), manufacturers must provide to the notified bodies referred to in Article 4 all relevant information to allow evaluation of their risk analysis and risk management strategy in accordance with Article 5(2).
Za medicinske pripomočke iz člena 1(1) mora proizvajalec priglašenim organom iz člena 4 zagotoviti vse ustrezne informacije in s tem omogočiti ovrednotenje svoje strategije analize in obvladovanja tveganja v skladu s členom 5(2).
Information of the Notified Body regarding changes and new information
Obveščanje priglašenega organa o spremembah in novih informacijah
Any change in relation to processes of sourcing, collection, handling, processing and inactivation or elimination and any new information on TSE risk collected by the manufacturer and relevant for the medical device that could modify the result of the manufacturer’s risk assessment must be transmitted to the notified body and, where applicable, needs to be approved by the notified body prior to its implementation.
Kakršno koli spremembo postopkov izbora, zbiranja, ravnanja, predelave in inaktiviranja ali odprave ter kakršno koli novo informacijo glede tveganja za TSE, ki jo pridobi proizvajalec v zvezi z medicinskim pripomočkom ter bi lahko spremenila izsledke proizvajalčeve ocene tveganja, je treba predložiti priglašenemu organu, ki jo mora po potrebi odobriti pred njenim izvajanjem.
Renewal of certificates
Podaljšanje certifikatov
In the context of its decision regarding the extension for a further period of maximum five years of an EC design-examination certificate or an EC type-examination certificate in accordance with Article 9(8) of Directive 90/385/EEC or Article 11(11) of Directive 93/42/EEC, respectively, the notified body shall review for the purpose of this Regulation at least the following aspects:
Priglašeni organ za namene te uredbe v okviru sklepa glede podaljšanja za obdobje največ pet let za ES-certifikat o pregledu načrtovanja ali ES-certifikat o tipskem pregledu v skladu s členom 9(8) Direktive 90/385/EGS oziroma členom 11(11) Direktive 93/42/EGS preuči vsaj naslednje vidike:
updated justification for the use of animal tissue or derivative, including a comparison with lower risk tissues or synthetic alternatives;
posodobljeno utemeljitev uporabe živalskega tkiva ali derivata, vključno s primerjavo s tkivi z nižjo stopnjo tveganja ali nadomestnimi sintetičnimi materiali;
updated risk analysis;
posodobljeno oceno tveganja;
updated clinical evaluation;
posodobljeno klinično ovrednotenje;
updated test data and/or rationales, for example in relation to the current harmonised standards;
posodobljene podatke o preskusih in/ali njihovi utemeljitvi, na primer v zvezi s trenutnimi usklajenimi standardi;
identification of any changes made since the issue of the original certificate (or last renewal) that could impact the TSE risk;
navedbo kakršnih koli sprememb od izdaje prvotnega certifikata (ali njegovega zadnjega podaljšanja), ki bi lahko vplivale na tveganje za TSE;
evidence that the design dossier remains state of the art in relation to TSE risks.
dokaze, da načrtovalna dokumentacija še vedno upošteva najnovejše dosežke glede tveganj za TSE.
Increase of the overall TSE risk
Povečanje splošnega tveganja za TSE
Where on the basis of information submitted in accordance with section 2.1 or 2.2 a notified body establishes that the overall TSE risk in relation to a medical device is increased, this notified body shall follow the procedure set out in Article 5.
Če priglašeni organ na podlagi informacij, predloženih v skladu z oddelkom 2.1 ali 2.2, ugotovi, da se je povečalo splošno tveganje za TSE v zvezi z medicinskim pripomočkom, mora ta priglašeni organ izvesti postopek iz člena 5.
RIGOROUS PROCESSES FOR TALLOW DERIVATIVES AS REFERRED TO IN ARTICLE 1, PARAGRAPH 4, OF THIS REGULATION
STROGI POSTOPKI ZA DERIVATE LOJA IZ ODSTAVKA 4 ČLENA 1 TE UREDBE
Trans-esterification or hydrolysis at not less than 200 °C for not less than 20 minutes under pressure (glycerol, fatty acids and fatty acid esters production),
Transesterifikacija ali hidroliza pri vsaj 200 °C in vsaj 20 minut pod tlakom (proizvodnja glicerola, maščobnih kislin in estrov maščobnih kislin),
Saponification with NaOH 12 M (glycerol and soap production)
saponifikacija z 12 M NaOH (proizvodnja glicerola in mila)
Batch process: at not less than 95 °C for not less than 3 hours,
serijski postopek: pri vsaj 95 °C in vsaj 3 ure,
Continuous process: at not less than 140 °C, under pressure for not less than 8 minutes or equivalent,
neprekinjen postopek: pri vsaj 140 °C in vsaj 8 minut pod tlakom ali enakovreden postopek,
Distillation at 200 °C.
destilacija pri 200 °C.
Summary Evaluation Report in accordance with Article 5(4) of Regulation (EU) No 722/2012
Povzetek poročila o oceni v skladu s členom 5(4) Uredbe (EU) št. 722/2012
Details relating to the submitting notified body
Podatki o priglašenem organu, ki je predložil poročilo
Name of notified body
Ime priglašenega organa
Notified body number
Številka priglašenega organa
Sent by
Pošiljatelj
Client reference (name of manufacturer and, if applicable, of authorised representative)
Podatki o prijavitelju (ime proizvajalca in morebitnega pooblaščenega zastopnika)
Confirmation that, in accordance with Article 11 of Directive 90/385/EEC and Article 16 of Directive 93/42/EEC, respectively, and Article 4 of Regulation (EU) No 722/2012, the submitting notified body has been designated by its competent authority for the conformity assessment of
Potrdilo, da je bil priglašeni organ, ki predlaga poročilo, v skladu s členom 11 Direktive 90/385/EGS oziroma členom 16 Direktive 93/42/EGS ter členom 4 Uredbe (EU) št. 722/2012 s strani pristojnega organa določen za ocenjevanje skladnosti
 active implantable medical devices manufactured utilising tissues of animal origin subject to Regulation (EU) No 722/2012,
 aktivnih medicinskih pripomočkov za vsaditev, izdelanih z uporabo tkiv živalskega izvora v skladu z Uredbo (EU) št. 722/2012,
 medical devices manufactured utilising tissues of animal origin subject to Regulation (EU) No 722/2012
 medicinskih pripomočkov, izdelanih z uporabo tkiv živalskega izvora v skladu z Uredbo (EU) št. 722/2012.
Data relating to the (active implantable) medical device
Podatki o (aktivnem) medicinskem pripomočku (za vsaditev)
 Active implantable medical device  Other medical device
 Aktivni medicinski pripomoček za vsaditev  Drug medicinski pripomoček
Product description and composition
Opis in sestava proizvoda
Information on intended use
Informacije o predvideni uporabi
Starting material
Vhodni material
EDQM certificate available  YES  NO
Na voljo je certifikat EDQM  DA  NE
(If the EDQM certificate is available, it must be submitted with this summary evaluation report.)
(Če je na voljo certifikat EDQM, ga je treba predložiti skupaj s tem povzetkom poročila o oceni.)
Information regarding
Informacije v zvezi z:
the nature of the starting tissue(s):
naravo vhodnih tkiv:
animal species(s):
živalskimi vrstami:
geographical source(s):
geografskim izvorom: