natgillin/translations-raw huggingface dataset:
Having regard to Council Decision (CFSP) 2015/1333 of 31 July 2015 concerning restrictive measures in view of the situation in Libya, and repealing Decision 2011/137/CFSP,
ob upoštevanju Sklepa Sveta (SZVP) 2015/1333 z dne 31. julija 2015 o omejevalnih ukrepih zaradi razmer v Libiji in razveljavitvi Sklepa 2011/137/SZVP,
Council Regulation (EU) 2016/44 gives effect to measures provided for in Decision (CFSP) 2015/1333.
Z Uredbo Sveta (EU) 2016/44 se uveljavljajo ukrepi iz Sklepa (SZVP) 2015/1333.
On 5 November 2018 the United Nations Security Council (UNSC) adopted Resolution 2441 (2018), reaffirming its strong commitment to the sovereignty, independence, territorial integrity and national unity of Libya and determining that the situation in Libya continues to constitute a threat to international peace and security.
Varnostni svet Združenih narodov (v nadaljnjem besedilu: VSZN) je 5. novembra 2018 sprejel Resolucijo 2441 (2018), s katero potrjuje svojo močno zavezanost suverenosti, neodvisnosti, ozemeljski nedotakljivosti in narodni enotnosti Libije ter ugotavlja, da razmere v Libiji še vedno ogrožajo mednarodni mir in varnost.
The UNSC decided to include new examples of conduct falling within the designation criteria.
Varnostni svet Združenih narodov je sklenil, da bo med merila za uvrstitev vključil nove primere ravnanja.
On 17 December 2018 the Council adopted Decision (CFSP) 2018/2012, amending Decision (CFSP) 2015/1333 in order to reflect the changes in UNSC Resolution 2441 (2018).
Svet je 17. decembra 2018 sprejel Sklep (SZVP) 2018/2012, s katerim se je spremenil Sklep (SZVP) 2015/1333, da bi se odražale spremembe v Resoluciji VSZN 2441 (2018).
These measures fall within the scope of the Treaty and, therefore, in particular with a view to ensuring their uniform application in all Member States, regulatory action at the level of the Union is necessary.
Ti ukrepi spadajo na področje uporabe Pogodbe, in zato je zlasti zaradi zagotovitve, da se bodo v vseh državah članicah enotno uporabljali, potrebno regulativno ukrepanje na ravni Unije.
Regulation (EU) 2016/44 should therefore be amended accordingly.
Uredbo (EU) 2016/44 bi bilo zato treba ustrezno spremeniti –
In Article 6 of Regulation (EU) 2016/44, paragraph 1 is replaced by the following:
V členu 6 Uredbe (EU) 2016/44 se odstavek 1 nadomesti z naslednjim:
Annex II shall include the natural or legal persons, entities and bodies designated by the Security Council or by the Sanctions Committee in accordance with paragraph 22 of UNSCR 1970 (2011), paragraph 19, 22 or 23 of UNSCR 1973 (2011), paragraph 4 of UNSCR 2174 (2014), paragraph 11 of UNSCR 2213 (2015), paragraph 11 of UNSCR 2362 (2017) or paragraph 11 of UNSCR 2441 (2018).’
Priloga II zajema fizične ali pravne osebe, subjekte in organe, ki jih je določil Varnostni svet ali Odbor za sankcije v skladu z odstavkom 22 RVSZN 1970 (2011), odstavkom 19, 22 ali 23 RVSZN 1973 (2011), odstavkom 4 RVSZN 2174 (2014), odstavkom 11 RVSZN 2213 (2015), odstavkom 11 RVSZN 2362 (2017) ali odstavkom 11 RVSZN 2441 (2018).“
Council Regulation (EU) 2016/44 of 18 January 2016 concerning restrictive measures in view of the situation in Libya and repealing Regulation (EU) No 204/2011 (OJ L 12, 19.1.2016, p. 1).
Uredba Sveta (EU) 2016/44 z dne 18. januarja 2016 o omejevalnih ukrepih zaradi razmer v Libiji in razveljavitvi Uredbe (EU) št. 204/2011 (UL L 12, 19.1.2016, str. 1).
Council Decision (CFSP) 2018/2012 of 17 December 2018 amending Decision (CFSP) 2015/1333 concerning restrictive measures in view of the situation in Libya (see page 51 of this Official Journal).
Sklep Sveta (SZVP) 2018/2012 z dne 17. decembra 2018 o spremembi Sklepa (SZVP) 2015/1333 o omejevalnih ukrepih zaradi razmer v Libiji (glej stran 51 tega Uradnega lista).
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP)
o spremembi Priloge XVII k Uredbi (ES) št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) glede bis(2-etilheksil)ftalata (DEHP), dibutil ftalata (DBP), benzil butil ftalata (BBP) in diizobutil ftalata (DIBP)
Bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) (‘the four phthalates’) are listed in Annex XIV to Regulation (EC) No 1907/2006 as substances toxic for reproduction, category 1B, with a sunset date of 21 February 2015, specified in accordance with Article 58(1)(c)(i) of that Regulation.
Bis(2-etilheksil)ftalat (DEHP), dibutil ftalat (DBP), benzil butil ftalat (BBP) in diizobutil ftalat (DIBP) (v nadaljevanju: navedeni štirje ftalati) so navedeni v Prilogi XIV k Uredbi (ES) št. 1907/2006 kot snovi, strupene za razmnoževanje, kategorije 1B z datumom poteka 21. februar 2015, določenim v skladu s členom 58(1)(c)(i) navedene uredbe.
After the sunset date referred to in Article 58(1)(c)(i) for a substance listed in Annex XIV, Article 69(2) of Regulation (EC) No 1907/2006 requires the European Chemicals Agency (‘the Agency’) to consider whether the use in articles of substances listed in Annex XIV to that Regulation poses a risk to human health or the environment that is not adequately controlled and, if the Agency considers that it does, to prepare a dossier for a restriction proposal which conforms to the requirements of Annex XV to Regulation (EC) No 1907/2006 (‘the Annex XV dossier’).
Po datumu poteka iz člena 58(1)(c)(i) za snov iz Priloge XIV člen 69(2) Uredbe (ES) št. 1907/2006 določa, da Evropska agencija za kemikalije (v nadaljnjem besedilu: Agencija) preuči, ali uporaba snovi iz Priloge XIV k navedeni uredbi v izdelkih pomeni tveganje za zdravje ljudi ali okolje, ki ni ustrezno nadzorovano, in če Agencija meni, da to tveganje ni ustrezno nadzorovano, pripravi dokumentacijo za predlog omejitve, ki je v skladu z zahtevami iz Priloge XV k Uredbi (ES) št. 1907/2006 (v nadaljnjem besedilu: dokumentacija v skladu s Prilogo XV).
On 1 April 2016, the Agency, in cooperation with Denmark, submitted an Annex XV dossier for the four phthalates.
Agencija je 1. aprila 2016 v sodelovanju z Dansko za navedene štiri ftalate predložila dokumentacijo v skladu s Prilogo XV.
The dossier built on a previous restriction proposal submitted by Denmark in 2011 in relation to which the Agency's Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) adopted opinions based on which the Commission decided not to amend Annex XVII to Regulation (EC) No 1907/2006 on the grounds that the data available at the time did not indicate that combined exposure to the four phthalates presented a risk.
Dokumentacija je temeljila na prejšnjem predlogu omejitve, ki ga je Danska predložila leta 2011 ter glede katerega sta odbora Agencije za oceno tveganja (v nadaljnjem besedilu: RAC) in za socialno-ekonomsko analizo (v nadaljnjem besedilu: SEAC) sprejela mnenji, na podlagi katerih je Komisija odločila, da ne bo spremenila Priloge XVII k Uredbi (ES) št. 1907/2006, ker iz takrat razpoložljivih podatkov ni bilo razvidno, da kombinirana izpostavljenost navedenim štirim ftalatom pomeni tveganje.
The 2016 Annex XV dossier took into account new information on exposure from different sources including human biomonitoring data from the Union-wide DEMOCOPHES project which measures the presence of the four phthalates in urine samples.
V dokumentaciji v skladu s Prilogo XV iz leta 2016 so upoštevane nove informacije o izpostavljenosti iz različnih virov, vključno s podatki o biospremljanju prebivalstva, zbranimi v okviru vseevropskega projekta DEMOCOPHES, ki meri prisotnost navedenih štirih ftalatov v urinu.
The four phthalates are found in a wide variety of articles as they are commonly present in plasticised materials.
Navedeni štirje ftalati so prisotni v vrsti izdelkov, saj so pogosto prisotni v plastificiranih materialih.
Exposure may occur through the ingestion of food and dust, the placing of articles in the mouth, the inhalation of air and dust in indoor environments, and contact of dust and articles with human mucous membranes and skin.
Do izpostavljenosti lahko pride z zaužitjem hrane in prahu, dajanjem izdelkov v usta, vdihavanjem zraka in prahu v zaprtih prostorih ter stikom človeške kože in sluznic s prahom in izdelki.
The Annex XV dossier proposed to restrict the placing on the market of articles containing the four phthalates in a concentration equal to or greater than 0,1 % by weight individually or in any combination in such plasticised materials.
V dokumentaciji v skladu s Prilogo XV je predlagana omejitev dajanja na trg izdelkov, ki vsebujejo navedene štiri ftalate v koncentraciji, ki je enaka ali večja od 0,1 masnega odstotka, posamezno ali v kateri koli kombinaciji v takšnih plastificiranih materialih.
This concentration limit would effectively discourage the use of the four phthalates in articles within the scope of the restriction.
Ta omejitev koncentracije bi učinkovito odvračala od uporabe navedenih štirih ftalatov v izdelkih s področja uporabe omejitve.
The dossier suggested exemptions for articles exclusively for open air use without prolonged contact with skin or contact with mucous membranes, certain articles exclusively for industrial and agricultural use, measuring devices, articles covered by existing Union legislation and articles already placed on the market in the Union.
V dokumentaciji so predlagane izjeme za izdelke, namenjene izključno za uporabo na prostem brez daljšega stika s kožo ali stika s sluznico, nekatere izdelke, namenjene izključno za industrijsko in kmetijsko uporabo, merilne naprave, izdelke, zajete v veljavni zakonodaji Unije, in izdelke, ki so že bili dani na trg v Uniji.
On 10 March 2017, RAC adopted its opinion concluding that the proposed restriction is the most appropriate Union-wide measure to address the identified risks arising from these substances in terms of effectiveness in reducing those risks.
RAC je 10. marca 2017 sprejel mnenje, v katerem je sklenil, da je predlagana omejitev najprimernejši ukrep na ravni Unije za zmanjšanje ugotovljenih tveganj, ki jih pomenijo navedene snovi, glede na učinkovitost pri zmanjševanju tveganja.
RAC considered that a combined concentration of the four phthalates of 0,1 % or less in plasticised materials in articles is required to address the risk to human health.
RAC je menil, da je za zmanjšanje tveganja za zdravje ljudi v plastificiranih materialih v izdelkih potrebna skupna koncentracija navedenih štirih ftalatov v višini 0,1 % ali manj.
On 15 June 2017, SEAC adopted its opinion, indicating that the proposed restriction, as modified by RAC and SEAC, is the most appropriate Union-wide measure to address the identified risks in terms of its socioeconomic benefits and socioeconomic costs.
SEAC je 15. junija 2017 sprejel mnenje, v katerem je navedel, da je predlagana omejitev, kakor sta jo spremenila RAC in SEAC, najprimernejši ukrep na ravni Unije za zmanjšanje ugotovljenih tveganj glede na socialno-ekonomske koristi in stroške.
SEAC concurred with the conclusions in the Annex XV dossier that a deferral of 36 months of the application of the restriction seems reasonable and sufficient in order to enable actors involved in the supply chains to comply with it.
SEAC se je strinjal s sklepi iz dokumentacije v skladu s Prilogo XV, in sicer da je odlog uporabe omejitve za 36 mesecev razumno in dovolj dolgo obdobje, ki bi zadevnim akterjem v dobavni verigi omogočalo uskladitev s to odločbo.
SEAC also concurred with the exemptions suggested in the Annex XV dossier.
SEAC se je strinjal tudi z izjemami, predlaganimi v dokumentaciji v skladu s Prilogo XV.
In addition, due to socioeconomic considerations based on additional information provided by the automotive and aircraft sectors during the public consultation, SEAC suggested certain derogations for these sectors.
Poleg tega je SEAC zaradi socialno-ekonomskih pomislekov na podlagi dodatnih informacij, ki sta jih med javnim posvetovanjem predložila avtomobilski in letalski sektor, za ta sektorja predlagal nekatera odstopanja.
The Agency's Forum for Exchange of Information on Enforcement (‘Forum’), referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006, was consulted on the proposed restriction and its recommendations have been taken into account.
Za mnenje o predlagani omejitvi je bil zaprošen forum Agencije za izmenjavo informacij o izvrševanju (v nadaljnjem besedilu: forum) iz člena 76(1)(f) Uredbe (ES) št. 1907/2006 in njegova priporočila so bila upoštevana.
On 29 August 2017, the Agency submitted the opinions of RAC and SEAC to the Commission.
Agencija je 29. avgusta 2017 Komisiji predložila mnenji RAC in SEAC.
Based on those opinions concluding on the combined exposure via various routes to these four phthalates that adversely affect human health, the Commission concluded that the four phthalates pose an unacceptable risk to human health when present in any plasticised material in articles at a concentration, individually or in any combination, equal to or greater than 0,1 % by weight of any of such material.
Na podlagi navedenih mnenj o kombinirani izpostavljenosti prek različnih poti navedenim štirim ftalatom, ki negativno vplivajo na zdravje ljudi, je Komisija sklenila, da navedeni štirje ftalati predstavljajo nesprejemljivo tveganje za zdravje ljudi, kadar so prisotni v plastificiranem materialu v izdelkih v koncentraciji – posamezno ali v kateri koli kombinaciji –, ki je enaka ali večja od 0,1 masnega odstotka takega materiala.
For the purposes of this restriction, plasticised materials are materials that may contain phthalates for which there is great potential for combined exposure, via various routes, of both consumers and workers.
Za namene te omejitve so plastificirani materiali materiali, ki lahko vsebujejo ftalate, pri katerih obstaja velika verjetnost, da jim bodo potrošniki in delavci izpostavljeni prek različnih poti.
Those materials include polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethanes, any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings, surface coatings, non-slip coatings, finishes, decals, printed designs, adhesive, sealants, inks and paints.
Navedeni materiali vključujejo polivinil klorid (PVC), poliviniliden klorid (PVDC), polivinil acetat (PVA), poliuretane, druge polimere (med drugim polimerne pene in gumijasti material), razen silikonske gume in premazov z naravnim lateksom, površinske premaze, premaze proti drsenju, obloge, folije z lepilom, tiskane motive, lepila, tesnilne mase, črnila in barve.
The Commission considers that the risk needs to be addressed on a Union-wide basis.
Komisija meni, da je navedeno tveganje treba obravnavati na ravni Unije.
Annex XVII to Regulation (EC) No 1907/2006 already bans the placing on the market of toys and childcare articles containing DEHP, DBP and BBP under certain conditions which fall within the scope of the proposed restriction.
Priloga XVII k Uredbi (ES) št. 1907/2006 že prepoveduje dajanje na trg igrač in izdelkov za nego otrok, ki vsebujejo DEHP, DBP in BBP, pod nekaterimi pogoji, ki spadajo na področje uporabe predlagane omejitve.
In addition, in view of both the opinion of RAC that DIBP has a hazard profile similar to that of DEHP, DBP and BBP, that toys and childcare articles can contribute considerably to risks for infants from phthalates and that DIBP can replace DBP in toys and childcare articles, and the recommendation of the Forum, the Commission takes the view that the placing on the market of toys and childcare articles containing DIBP should also be restricted.
Poleg tega Komisija tako na podlagi mnenja RAC, da ima DIBP podoben profil nevarnosti kot DEHP, DBP in BBP, da lahko igrače in izdelki za nego otrok znatno prispevajo k tveganju za dojenčke zaradi ftalatov in da lahko DIBP zamenja DBP v igračah in izdelkih za nego otrok, kot priporočila foruma meni, da bi bilo treba omejiti tudi dajanje na trg igrač in izdelkov za nego otrok, ki vsebujejo DIBP.
In addition, the placing on the market of the four phthalates in toys and childcare articles should be subject to updated conditions.
Nadalje bi morali za dajanje na trg navedenih štirih ftalatov v igračah in izdelkih za nego otrok veljati posodobljeni pogoji.
In the case of articles exclusively for industrial and agricultural use, or for open air use, the proposed restriction should only apply to those articles containing plasticised material that comes into contact with human mucous membranes or into prolonged contact with the skin, because such contacts lead to exposure which poses risk to human health.
V primeru izdelkov, ki se namenjeni izključno za industrijsko in kmetijsko uporabo ali uporabo na prostem, bi morala predlagana omejitev veljati samo za izdelke, ki vsebujejo plastificirani material, ki pride v stik s sluznico ali daljši stik s kožo, ker tak stik vodi v izpostavljenost, ki pomeni tveganje za zdravje ljudi.
The proposed restriction should not apply to articles regulated by other Union legislation, such as materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council and Commission Regulation (EU) No 10/2011, medical devices within the scope of Council Directives 90/385/EEC or 93/42/EEC, or Directive 98/79/EC of the European Parliament and of the Council, or components for such devices, articles within the scope of Directive 2011/65/EU of the European Parliament and of the Council or the immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council or of Directives 2001/82/EC or 2001/83/EC of the European Parliament and of the Council.
Predlagana omejitev se ne bi smela uporabljati za izdelke, ki jih ureja druga zakonodaja Unije, kot so materiali in izdelki, namenjeni za stik z živili s področja uporabe Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004 in Uredbe Komisije (EU) št. 10/2011, medicinski pripomočki s področja uporabe direktiv Sveta 90/385/EGS in 93/42/EGS ter Direktive 98/79/ES Evropskega parlamenta in Sveta ali deli takih pripomočkov in izdelkov s področja uporabe Direktive 2011/65/EU Evropskega parlamenta in Sveta ali stična ovojnina zdravil s področja uporabe Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta ali direktiv 2001/82/ES oziroma 2001/83/ES Evropskega parlamenta in Sveta.
The proposed restriction should also not apply to measuring devices for laboratory use or articles that form part of such devices and to articles placed on the market prior to the date of entry into application of the restriction, for practicality and enforceability reasons.
Zaradi praktičnosti in izvršljivosti se predlagana omejitev prav tako ne bi smela uporabljati za merilne naprave za laboratorijsko uporabo ali izdelke, ki so del takih naprav, in izdelke, ki so dani na trg pred začetkom uporabe omejitve.
Moreover, certain derogations should apply for motor vehicles and aircraft.
Poleg tega bi za motorna vozila in zrakoplove morala veljati nekatera odstopanja.
First, a longer deferral of application of the restriction for motor vehicles and an indefinite exemption for articles used in the maintenance or repair of those vehicles, where the vehicles cannot function as intended without those articles, are justified in consideration of the specific economic implications of this sector.
Prvič, daljši odlog uporabe omejitve za motorna vozila in neomejeno izvzetje za izdelke, ki se uporabljajo za vzdrževanje ali popravilo vozil, če ta brez teh izdelkov ne morejo delovati, kot je predvideno, sta upravičena ob upoštevanju gospodarskih posledic za zadevni sektor.
A longer deferral of application of the restriction for certain aircraft and an indefinite exemption for articles used in the maintenance or repair of those aircraft where these are essential for safety and airworthiness, are justified on the basis that aircrafts have a very long useful life, their airworthiness may be jeopardised if parts meeting the design specifications are not available and the timelines needed for requalification are very long.
Daljši odlog uporabe omejitve za nekatere zrakoplove in neomejeno izvzetje za izdelke, ki se uporabljajo za vzdrževanje ali popravilo navedenih zrakoplovov, če so ti izdelki nujni za varnost in plovnost, sta upravičena, ker imajo zrakoplovi zelo dolgo življenjsko dobo in je njihova plovnost lahko ogrožena, če deli, ki izpolnjujejo specifikacije zasnove, niso na voljo, in so časovni okviri, potrebni za prekvalifikacijo, zelo dolgi.
Taking into account the Annex XV dossier as well as the opinions of RAC and SEAC, the Commission considers that the proposed restriction would address the identified risks without imposing significant burden on industry, supply chain or consumers and concludes that the restriction proposed, is an appropriate Union-wide measure to address the identified risk.
Ob upoštevanju dokumentacije v skladu s Prilogo XV ter mnenj RAC in SEAC Komisija meni, da bi predlagana omejitev zmanjšala ugotovljena tveganja, ne da bi pomenila znatno obremenitev za industrijo, dobavno verigo ali potrošnike, in ugotavlja, da je predlagana omejitev ustrezen ukrep na ravni Unije za zmanjšanje ugotovljenih tveganj.
Stakeholders should be allowed sufficient time to take appropriate measures to comply with the proposed restriction and 18 months is sufficient to this end.
Deležnikom bi morali omogočiti dovolj dolgo obdobje, da bi lahko sprejeli ustrezne ukrepe za uskladitev s predlagano omejitvijo, in 18 mesecev je za ta namen ustrezno časovno obdobje.
Therefore there should be a general deferral of its application by 18 months.
Zato bi moral veljati 18-mesečni splošni odlog uporabe omejitve.
A longer specific deferral of 60 months should apply to address the particular cases of certain motor vehicles and aircraft.
Pri obravnavi posebnih primerov nekaterih motornih vozil in zrakoplovov bi se moral uporabljati daljši, 60-mesečni odlog.
2012 RAC and SEAC Opinion on an Annex XV dossier proposing restrictions on the four phthalates: https://echa.europa.eu/documents/10162/58050be8-f7be-4b55-b106-76dda4989dd6
Mnenji RAC in SEAC o dokumentaciji v skladu s Prilogo XV glede predloga omejitev navedenih štirih ftalatov iz leta 2012: https://echa.europa.eu/documents/10162/58050be8-f7be-4b55-b106-76dda4989dd6.
Commission Communication 2014/C 260/01.
Sporočilo Komisije 2014/C 260/01.
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Uredba Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS (UL L 338, 13.11.2004, str. 4).
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).
Uredba Komisije (EU) št. 10/2011 z dne 14. januarja 2011 o polimernih materialih in izdelkih, namenjenih za stik z živili (UL L 12, 15.1.2011, str. 1).
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
Direktiva Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev (UL L 189, 20.7.1990, str. 17).
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (UL L 169, 12.7.1993, str. 1).
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
Direktiva 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih (UL L 331, 7.12.1998, str. 1).