natgillin/translations-raw huggingface dataset:
Transmitting heading device THD (Magnetic method)
Postavka prestavljena v A.1/4.33.
Moved to A.1/4.2
Elektronska pomorska karta s podatki za zaščito (ECDIS)
Moved to A.1/4.22
Oprema DGPS, DGLONASS
Moved to A.1/4.54
Postavka prestavljena v A.1/4.44, A.1/4.50 in A.1/4.51.
Moved to A.1/4.57
Postavka prestavljena v A.1/4.29.
(working at ship's speed from 30 knots and above)
Postavka prestavljena v A.1/4.59.
Equipment with Long Range Identification and Tracking (LRIT) capability
Sistem za opremo mostov
Moved to A.1/4.56
Postavka prestavljena v A.1/4.53.
AIS SART equipment
Postavka prestavljena v A.1/4.58.
Reg.
visokohitrostna plovila Prav.
IMO Res. MSC.363(92),
Postavka prestavljena v A.1/4.45.
IEC 61162 Series.
Kazalnik potisne sile Prav.
Ex A.1/4.11
Kazalniki bočne potisne sile, stanja propelerja in načina plovbe Prav.
IMO Res. A.818(19),
Postavka prestavljena v A.1/4.9.
Ex A.1/4.12
Postavka prestavljena v A.1/4.20.
IMO Res. A.818 (19),
Postavka prestavljena v A.1/4.21.
A.2/5.1
Postavka prestavljena v A.1/4.22.
VHF EPIRB
Postavka prestavljena v A.1/4.54.
Reg.
Postavka prestavljena v A.1/4.56.
Inmarsat-F SES
Elektronski inklinometer
Ship security alert system
IMO MSC.1/Okr.
Loading instrument
A.702(17), IMO Res.
1997 SOLAS Conference Res. 5.
IV/6, IMO Res.
SOLAS Chapter II-1 equipment
Ladijski sistem opozarjanja na nevarnost Reg.
IMO Res. MSC.97(73)-(2000 HSC Code) 12.
A.1/5.16
IMO MSC.1/Circ 1464 Rev.1.
MSC.80(70), IMO COMSAR Okr.
HSC, High Speed Craft Code.
Konvencija ICAO, Priloga 10, radijski pravilniki.
ICAO, International Civil Aviation Organization.
Naprave za zvočni signal
Column 1: Article 2 of Commission Directive 2013/52/EU [1] may apply.
COLREG 72, Priloga III/3.
EN ISO 10497 (2010).
Instrument za nakladanje Prav.
Automatic radar plotting aid (ARPA) for high-speed craft
(2014-07) – 3. del: Instrumentno omrežje s serijskimi podatki
amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
o spremembi Direktive 2006/86/ES v zvezi z nekaterimi tehničnimi zahtevami za kodiranje človeških tkiv in celic
Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 [1] on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, and in particular Article 28 thereof,
ob upoštevanju Direktive 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic [1] ter zlasti člena 28 Direktive,
Directive 2004/23/EC requires that Member States ensure the traceability of human tissues and cells from the donor to the recipient and vice versa.
Direktiva 2004/23/ES določa, da države članice zagotovijo sledljivost človeških tkiv in celic od darovalca do prejemnika in obratno.
In order to facilitate traceability it is necessary to establish a unique identifier applied to tissues and cells distributed in the Union (Single European Code) providing information on the main characteristics and properties of those tissues and cells.
Za lažjo sledljivost je treba določiti edinstveni identifikator za tkiva in celice, ki se razdeljujejo v Uniji („enotna evropska koda“), z informacijami o glavnih značilnostih in lastnostih navedenih tkiv in celic.
In order to ensure a uniform implementation of the Single European Code throughout the Union, obligations of the Member States competent authorities and of the tissue establishments for the application of the Single European Code should be set out.
Za zagotovitev usklajene uporabe enotne evropske kode po vsej Uniji bi bilo treba določiti obveznosti pristojnih organov držav članic in ustanov za tkiva za uporabo enotne evropske kode.
Only this approach will guarantee a consistent and coherent application of the code in the Union.
Le tak pristop bo zagotovil dosledno in usklajeno uporabo kode v Uniji.
Traceability from donor to recipient and vice versa should be ensured through coding of tissues and cells and through accompanying documentation.
Sledljivost od darovalca do prejemnika in obratno bi bilo treba zagotoviti s kodiranjem tkiv in celic ter spremljajočo dokumentacijo.
At the recipient end, the Single European Code provides information on the donation and on the tissue establishment responsible for the procurement of tissues and cells.
Enotna evropska koda za prejemnika zagotavlja informacije o darovanju in ustanovi za tkiva, ki je pristojna za pridobivanje tkiv in celic.
At the donor end, the tissue establishment responsible for the procurement of tissues and cells may track the tissues and cells distributed for human application by requesting the next operators in the chain to provide data related to the use of the tissues and cells based on the donation identification elements of the Single European Code as contained in the accompanying documentation.
Za darovalca pa ustanova za tkiva, pristojna za pridobivanje tkiv in celic, lahko izsledi tkiva in celice, razdeljene za zdravljenje ljudi, tako da od nadaljnjih izvajalcev v verigi zahteva, da predložijo podatke v zvezi z uporabo tkiv in celic na podlagi identifikacijskih elementov enotne evropske kode za darovanje, kot so navedeni v priloženi dokumentaciji.
The format of the Single European Code should be harmonised in order to facilitate its application by small and large establishments, whilst allowing some flexibility for establishments to continue using existing codes.
Obliko enotne evropske kode bi bilo treba uskladiti, da se malim in velikim ustanovam olajša njena uporaba, hkrati pa omogoči nekaj prožnosti za ustanove, da še naprej uporabljajo obstoječe kode.
A Single European Code allowing for donation and product identification should be allocated to all tissues and cells distributed for human application, including those imported from third countries.
Enotno evropsko kodo, ki omogoča identifikacijo darovanja in izdelkov, bi bilo treba uporabiti za vsa tkiva in celice, razdeljene za zdravljenje ljudi, vključno s tistimi, ki se uvažajo iz tretjih držav.
Member States may allow certain exemptions from the application of the code.
Države članice lahko dovolijo nekatere izjeme pri uporabi kode.
Where tissues and cells are excluded or exempted from the application of the Single European Code, the Member States should ensure that appropriate traceability of these tissues and cells is guaranteed throughout the entire chain from donation and procurement to human application.
Kadar so tkiva in celice izključene ali izvzete iz uporabe enotne evropske kode, bi morale države članice zagotoviti ustrezno sledljivost teh tkiv in celic po celotni verigi od darovanja in pridobivanja do zdravljenja ljudi.
In situations where tissues and cells are released for circulation, other than for distribution (such as transfer to another operator for further processing with or without return), as a minimum the donation identification sequence should be applied at least in the accompanying documentation.
V primerih, v katerih se tkiva in celice sprostijo v promet in niso namenjena razdeljevanju (na primer prenos drugemu izvajalcu za nadaljnjo predelavo z vračilom ali brez), bi bilo treba uporabiti vsaj identifikacijsko zaporedje darovanja vsaj v priloženi dokumentaciji.
Where tissues and cells are transferred from a tissue establishment to another operator just for storage and/or for further distribution, the tissue establishment may already apply the Single European Code on their final label in addition to the donation identification sequence which should be applied at least in the accompanying documentation.
Kadar se tkiva in celice iz ustanove za tkiva prenesejo na drugega izvajalca samo za shranjevanje in/ali za nadaljnje razdeljevanje, lahko ustanova za tkiva poleg identifikacijskega zaporedja darovanja, ki bi ga bilo treba uporabiti vsaj v priloženi dokumentaciji, že uporabi enotno evropsko kodo na njeni končni nalepki.
In the case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across procurements.
V primeru tkiv in celic, ki jih od umrlega darovalca pridobijo skupine za pridobivanje, ki delajo za dve ustanovi za tkiva ali več, države članice zagotovijo ustrezen sistem sledljivosti za celoten postopek pridobivanja.
This may be ensured by developing a central system for the allocation of the unique donation numbers for each donation event recorded at national level, or by requiring all tissue establishments to ensure robust traceability links between the donation identification numbers allocated by each tissue establishment procuring or receiving tissue and cells originating from the same deceased donor.
To se lahko zagotovi z razvojem centralnega sistema za dodeljevanje edinstvenih številk darovanja za vsako darovanje, evidentirano na nacionalni ravni, ali z zahtevo za vse ustanove za tkiva, da zagotovijo zanesljive povezave za sledljivost med identifikacijskimi številkami darovanja, ki jih dodeli vsaka ustanova za tkiva, ki pridobi ali prejme tkiva in celice istega umrlega darovalca.
The Commission should ensure the implementation of the Single European Code by providing the appropriate tools to the Member States competent authorities and tissue establishments.
Komisija bi morala zagotoviti uporabo enotne evropske kode z zagotavljanjem ustreznih orodij za pristojne organe držav članic in ustanove za tkiva.
The Member States competent authorities should update the register for tissue establishments, reflecting any changes in tissue establishment accreditations, designations, authorisations, or licences and the Commission should ensure the update of the register of the tissues and cells whenever new products need to be included.
Pristojni organi držav članic bi morali posodabljati register ustanov za tkiva v primeru kakršnih koli sprememb akreditacij, imenovanj, odobritev ali dovoljenj ustanov za tkiva, Komisija pa bi morala zagotavljati posodabljanje registra tkiv in celic, kadar koli je treba vključiti nove izdelke.
For this the Commission should consult a group of experts, in particular experts nominated by the Member States competent authorities.
Zato bi se Komisija morala posvetovati s skupino strokovnjakov, zlasti strokovnjakov, ki jih imenujejo pristojni organi držav članic.
For the donation identification sequence in the Single European Code, the importing tissue establishment should use the tissue establishment code allocated to it in the EU Tissue Establishment Compendium and should allocate a unique donation number if the donation number on the imported product is not globally unique.
Ustanova uvoznica za tkiva bi za identifikacijsko zaporedje darovanja v enotni evropski kodi morala uporabiti kodo ustanove za tkiva, dodeljeno ustanovi v EU-kompendiju ustanov za tkiva, in dodeliti edinstveno številko darovanja, če številka darovanja na uvoženem izdelku ni edinstvena na globalni ravni.
Pooling of tissues or cells is allowed in some Member States.
V nekaterih državah članicah je dovoljeno združevanje tkiv ali celic.
Therefore, the application of the Single European Code in case of pooling is also addressed by this Directive.
Zato je v tej direktivi obravnavana tudi uporaba enotne evropske kode v primeru združevanja.
A transitional regime for tissues and cells already in storage at the end of the transposition period should be introduced.
Uvesti bi bilo treba prehodni sistem za tkiva in celice, ki se bodo že hranila ob koncu obdobja za prenos.
This Directive does not prevent Member States from maintaining or introducing more stringent measures relating to coding of tissues and cells, provided that the provisions of the Treaty are met.
Ta direktiva državam članicam ne preprečuje, da ohranijo ali uvedejo strožje ukrepe za kodiranje tkiv in celic, pod pogojem, da se upoštevajo določbe iz Pogodbe.
The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 29 of Directive 2004/23/EC,
Ukrepi iz te direktive so v skladu z mnenjem odbora, ustanovljenega s členom 29 Direktive 2004/23/ES –
Commission Directive 2006/86/EC [2] is hereby amended as follows:(1) In Article 2, the following points (k) to (y) are added:
Direktiva Komisije 2006/86/ES [2] se spremeni:(1) V členu 2 se dodajo naslednje točke (k) do (y):
“Single European Code” or “SEC” means the unique identifier applied to tissues and cells distributed in the Union.
‚enotna evropska koda‘ ali ‚SEC‘ pomeni edinstven identifikator tkiv in celic, ki se razdeljujejo v Uniji.
The Single European Code consists of a donation identification sequence and a product identification sequence, as further specified in Annex VII to this Directive;
Enotno evropsko kodo sestavljata identifikacijsko zaporedje darovanja in identifikacijsko zaporedje izdelka, kot sta nadalje opredeljena v Prilogi VII k tej direktivi;
“donation identification sequence” means the first part of the Single European Code consisting of the EU tissue establishment code and the unique donation number;
‚identifikacijsko zaporedje darovanja‘ pomeni prvi del enotne evropske kode ter je sestavljen iz EU-kode ustanove za tkiva in edinstvene številke darovanja;
“EU tissue establishment code” means the unique identifier for accredited, designated, authorised, or licensed tissue establishments in the Union.
‚EU-koda ustanove za tkiva‘ pomeni edinstven identifikator ustanov za tkiva z akreditacijo, imenovanjem, odobritvijo ali dovoljenjem v Uniji.
The tissue establishment code consists of an ISO country code and the tissue establishment number set out in the EU Tissue Establishment Compendium, as further specified in Annex VII to this Directive;
Kodo ustanove za tkiva sestavljata ISO oznaka države in številka ustanove za tkiva iz EU-kompendija ustanov za tkiva, kot sta nadalje opredeljeni v Prilogi VII k tej direktivi;
“unique donation number” means the unique number attributed to a specific donation of tissues and cells in line with the system in place in each Member State for allocating such numbers, as further specified in Annex VII to this Directive;
‚edinstvena številka darovanja‘ pomeni edinstveno številko, pripisano določenemu darovanju tkiv in celic v skladu s sistemom, ki velja v vsaki državi članici za dodeljevanje takih številk, kot je nadalje opredeljeno v Prilogi VII k tej direktivi;
“product identification sequence” means the second part of the Single European Code consisting of the product code, the split number and the expiry date;
‚identifikacijsko zaporedje izdelka‘ pomeni drugi del enotne evropske kode, ki ga sestavljajo koda izdelka, številka podskupine lotov in datum izteka roka uporabnosti;
“product code” means the identifier for the specific type of tissue and cell in question.
‚koda izdelka‘ pomeni identifikator določene vrste zadevnega tkiva in celice.
The product code consists of the product coding system identifier indicating the coding system used by the tissue establishment (“E” for the EUTC, “A” for ISBT128, “B” for Eurocode) and the tissues and cells product number foreseen in the respective coding system for the product type, as further defined in Annex VII to this Directive;
Kodo izdelka sestavljata identifikator sistema kodiranja izdelka, ki označuje sistem kodiranja, ki ga uporablja ustanova za tkiva (‚E‘ za EUTC, ‚A‘ za ISBT128, ‚B‘ za Eurocode), ter številka izdelka iz tkiv in celic, predvidena v ustreznih sistemih kodiranja za vrsto izdelka, kot je nadalje opredeljeno v Prilogi VII k tej direktivi;
“split number” means the number which distinguishes and uniquely identifies tissues and cells having the same unique donation number and the same product code and originating from the same tissue establishment, as further defined in Annex VII to this Directive;
‚številka podskupine lotov‘ pomeni številko, ki razlikuje in edinstveno identificira tkiva in celice z isto edinstveno številko darovanja in isto kodo izdelka, ki prihajajo iz iste ustanove za tkiva, kot je nadalje opredeljeno v Prilogi VII k tej direktivi;
“expiry date” means the date by which the tissues and cells can be applied, as further defined in Annex VII to this Directive;
‚datum izteka roka uporabnosti‘ pomeni datum, do katerega se tkiva in celice lahko uporabljajo, kot je nadalje opredeljeno v Prilogi VII k tej direktivi;
“EU Coding Platform” means the IT platform hosted by the Commission which contains the EU Tissue Establishment Compendium and the EU Tissue and Cell Product Compendium;
‚platforma EU za kodiranje‘ pomeni informacijsko platformo, ki jo gosti Komisija ter zajema EU-kompendij ustanov za tkiva in EU-kompendij izdelkov iz tkiv in celic;
“EU Tissue Establishment Compendium” means the register of all tissue establishments which are authorised, licensed, designated or accredited by the Member States' competent authority or authorities and which contains the information about these tissue establishments as set out in Annex VIII to this Directive;
‚EU-kompendij ustanov za tkiva‘ pomeni register vseh ustanov za tkiva, za katere pristojni organi držav članic izdajo odobritev, dovoljenje, imenovanje ali akreditacijo in ki zajema informacije o teh ustanovah za tkiva, kot so določene v Prilogi VIII k tej direktivi;
“EU Tissue and Cell Product Compendium” means the register of all types of tissues and cells circulating in the Union and the respective product codes under the three permitted coding systems (EUTC, ISBT128 and Eurocode);
‚EU-kompendij izdelkov iz tkiv in celic‘ pomeni register vseh vrst tkiv in celic, ki so v prometu v Uniji, in ustreznih kod izdelkov v okviru treh dovoljenih sistemov kodiranja (EUTC, ISBT128 in Eurocode);
“EUTC” means the product coding system for tissues and cells developed by the Union consisting of a register of all types of tissues and cells circulating in the Union and their corresponding product codes.
‚EUTC‘ pomeni sistem kodiranja izdelkov iz tkiv in celic, ki ga je razvila Unija ter zajema register vseh vrst tkiv in celic, ki so v prometu v Uniji, in njihove ustrezne kode izdelkov;
“released for circulation” means distribution for human application or transfer to another operator, e.g. for further processing with or without return.
‚sproščeno v promet‘ pomeni razdeljevanje za zdravljenje ljudi ali prenos na drugega izvajalca, npr. za nadaljnjo predelavo z vračilom ali brez njega;
“within the same centre” means that all steps from procurement to human application are carried out under the same responsible person, quality management system and traceability system, within a healthcare centre comprising at least an accredited, designated, authorised, or licensed tissue establishment and an organisation responsible for human application at the same location;
‚v istem centru‘ pomeni, da se vsi ukrepi od pridobivanja do zdravljenja ljudi opravljajo pod nadzorom iste odgovorne osebe, v okviru istega sistema upravljanja kakovosti in istega sistema sledljivosti v zdravstvenem centru, ki zajema vsaj ustanovo za tkiva z akreditacijo, imenovanjem, odobritvijo ali dovoljenjem ter organizacijo, pristojno za zdravljenje ljudi, na isti lokaciji;
“pooling” means the physical contact or mixing in a single container, of tissues or cells from more than one procurement from the same donor, or from two or more donors.’
‚združevanje‘ pomeni fizični stik ali mešanje tkiv ali celic iz več kot enega postopka pridobivanja od istega darovalca ali od dveh ali več darovalcev v eni sami embalaži.“
Member States shall ensure that tissues and cells shall be traceable in particular through documentation and the use of the Single European Code from procurement to human application or disposal and vice versa.
Države članice zagotovijo, da so tkiva in celice sledljivi, zlasti z dokumentacijo in uporabo enotne evropske kode v okviru postopka pridobivanja za zdravljenje ljudi ali odstranitve in obratno.
Tissues and cells used for advanced therapy medicinal products shall be traceable under this Directive at least until transferred to the ATMP manufacturer.
Tkiva in celice, ki se uporabljajo za zdravila za napredno zdravljenje, so sledljiva na podlagi te direktive vsaj dokler niso prenesena proizvajalcu zdravil za napredno zdravljenje.
Member States shall ensure that tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, using an appropriate and readable storage medium.
Države članice zagotovijo, da ustanove za tkiva in organizacije, pristojne za zdravljenje ljudi, hranijo podatke iz Priloge VI vsaj 30 let z uporabo ustreznega in berljivega pomnilniškega medija.
In case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across the procurements.’
V primeru tkiv in celic, ki jih od umrlega darovalca pridobijo skupine za pridobivanje, ki delajo za dve ustanovi za tkiva ali več, države članice zagotovijo ustrezen sistem sledljivosti za celoten postopek pridobivanja.“
European coding system
Evropski sistem kodiranja
Without prejudice to paragraphs 2 or 3 of this Article, a Single European Code shall be applied to all tissues and cells distributed for human application.
Brez poseganja v odstavek 2 ali 3 tega člena se enotna evropska koda uporabi za vsa tkiva in celice, razdeljene za zdravljenje ljudi.
For the other situations where tissues and cells are released for circulation, as a minimum the donation identification sequence shall be applied at least in the accompanying documentation.
Za druge primere, v katerih so tkiva in celice sproščene v promet, se uporabi vsaj identifikacijsko zaporedje darovanja vsaj v priloženi dokumentaciji.
reproductive cells from partner donation;
reproduktivne celice pri darovanju med partnerjema;
tissues and cells distributed directly for immediate transplantation to the recipient, as referred to in Article 6(5) of Directive 2004/23/EC;
tkiva in celice, ki se razdelijo neposredno prejemniku za takojšnjo presaditev, kot je navedeno v členu 6(5) Direktive 2004/23/ES;
tissues and cells imported into the Union in case of emergency authorised directly by the competent authority or authorities, as referred to in Article 9(3)b of Directive 2004/23/EC.
tkiva in celice, uvožene v Unijo v nujnih primerih, ki jih neposredno odobrijo pristojni organi, kot je navedeno v členu 9(3)b Direktive 2004/23/ES.
Member States may also allow exemptions from the requirement provided for in paragraph 1 for:
Države članice lahko dovolijo tudi izjeme od zahteve iz odstavka 1 za:
tissues and cells other than reproductive cells for partner donation, when these tissues and cells remain within the same centre;
tkiva in celice, razen reproduktivnih celic za darovanje med partnerjema, kadar ta tkiva in celice ostanejo v istem centru;
tissues and cells that are imported into the Union, when these tissues and cells remain within the same centre from importation to application, provided that the centre comprises a tissue establishment authorised, designated, accredited, or licensed to carry out importing activities.’
tkiva in celice, uvožene v Unijo, ko ta tkiva in celice ostanejo v istem centru od uvoza do zdravljenja, pod pogojem, da center zajema ustanovo za tkiva z akreditacijo, imenovanjem, odobritvijo ali dovoljenjem za izvajanje uvoznih dejavnosti.“
Format of the Single European Code
Oblika enotne evropske kode
The Single European Code referred to in Article 10(1) shall comply with the specifications set out in this Article and in Annex VII.
Enotna evropska koda iz člena 10(1) izpolnjuje specifikacije, določene v tem členu in Prilogi VII.
The Single European Code shall be in eye-readable format and shall be preceded by the acronym “SEC”.
Enotna evropska koda je v obliki, berljivi s prostim očesom, pred njo pa je navedena okrajšava ‚SEC‘.
The parallel use of other labelling and traceability systems is possible.
Možna je vzporedna uporaba drugih sistemov označevanja in sledljivosti.