EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10
EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10
Medical Devices Regulation - Hazardous Substances
EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020
This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).
Last updated 26 srpnja 2024. Database contains 4917 unique substances/entries.
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Carc. 1A; Acute Tox. 3 |
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231-901-9
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7778-39-4
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C Carcinogenic (article 57a) |
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231-148-6
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7440-38-2
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Acute Tox. 3 |
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A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly greater than C10 and boiling in the range of approximately 150°C to 320°C (302°F to 608°F).
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292-621-0
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90640-98-5
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Asp. Tox. 1 |
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295-551-9
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92062-36-7
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Carc. 1B; Muta. 1B |
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292-694-9
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90989-38-1
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Carc. 1B; Muta. 1B |
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A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
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295-281-1
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91995-20-9
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Carc. 1B; Muta. 1B |
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292-695-4
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90989-39-2
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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295-279-0
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91995-18-5
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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292-698-0
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90989-42-7
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C (266°F to 392°F).
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297-401-8
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93571-75-6
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.
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270-658-3
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68475-70-7
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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292-697-5
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90989-41-6
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Carc. 1B; Muta. 1B |
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268-618-5
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68131-49-7
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
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309-958-7
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101794-76-7
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Carc. 1B |
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A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
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309-956-6
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101794-74-5
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Carc. 1B |
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A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
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309-957-1
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101794-75-6
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Carc. 1B |
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B Bacteria and similar species |
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201-706-3
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86-88-4
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Acute Tox. 2; Carc. 2 |
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215-175-0
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1309-64-4
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Carc. 2 |
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232-009-2
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7783-56-4
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Acute Tox. 3 |
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233-047-2
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10025-91-9
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Skin Corr. 1B |
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231-601-8
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7647-18-9
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Skin Corr. 1B |
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Acute Tox. 4 |
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201-549-0
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84-65-1
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Carc. 1B |
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A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
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292-602-7
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90640-80-5
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Carc. 1B |
C Carcinogenic (article 57a) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
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292-604-8
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90640-82-7
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Carc. 1B; Muta. 1B |
C Carcinogenic (article 57a) M Mutagen (article 57b) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
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292-603-2
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90640-81-6
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Carc. 1B; Muta. 1B |
C Carcinogenic (article 57a) M Mutagen (article 57b) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
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295-278-5
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91995-17-4
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Carc. 1B; Muta. 1B |
C Carcinogenic (article 57a) M Mutagen (article 57b) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
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295-276-4
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91995-16-3
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Carc. 1B; Muta. 1B |
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A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
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295-275-9
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91995-15-2
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Carc. 1B; Muta. 1B |
C Carcinogenic (article 57a) M Mutagen (article 57b) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
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295-274-3
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91995-14-1
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Carc. 1B |
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204-371-1
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120-12-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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200-539-3
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62-53-3
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Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1 |
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202-910-5
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101-05-3
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Eye Irrit. 2; Skin Irrit. 2 |
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P Parasites |
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P Parasites |
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433-560-3
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15375-21-0
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Repr. 2 |
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P Parasites |
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Amylase, mixed with proteinase, Bacillus thuringiensis-fermented
EC / List no:
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68909-36-4
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Resp. Sens. 1 |
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232-565-6
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9000-90-2
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Resp. Sens. 1 |
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223-320-4
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3825-26-1
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Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1 |
R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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4149-60-4
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Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1 |
R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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221-037-0
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2980-64-5
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Acute Tox. 2; Acute Tox. 1; STOT RE 2 |
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232-989-1
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9080-17-5
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Skin Corr. 1B |
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249-415-0
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29081-56-9
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Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact. |
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269-511-6
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68259-08-5
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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228-098-2
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6130-43-4
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R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) |
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232-235-1
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7790-98-9
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Expl. 1.1; Ox. Sol. 1 |
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221-470-5
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3108-42-7
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Carc. 2; Repr. 1B; Lact. |
R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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