EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 12 srpnja 2024. Database contains 4821 unique substances/entries.
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200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
200-543-5
62-56-6
Carc. 2; Repr. 2; Acute Tox. 4
200-541-4
62-55-5
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
200-532-5
62-38-4
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
200-521-5
61-82-5
Repr. 2; STOT RE 2
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
200-480-3
60-51-5
Acute Tox. 4
200-473-5
60-35-5
Carc. 2
200-471-4
60-34-4
Carc. 1B
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
200-453-6
60-09-3
Carc. 1B
yes
200-449-4
60-00-4
Eye Irrit. 2
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-431-6
59-50-7
Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; STOT SE 3; Skin Sens. 1B
200-402-8
58-90-2
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
200-401-2
58-89-9
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Lact.
200-397-2
58-74-2
Acute Tox. 4
200-362-1
58-08-2
Acute Tox. 4
200-349-0
57-74-9
Carc. 2; Acute Tox. 4
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
200-332-8
57-47-6
Acute Tox. 2
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
200-280-6
56-55-3
Carc. 1B
yes
200-271-7
56-38-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1
200-268-0
56-35-9
yes
200-262-8
56-23-5
Carc. 2; Acute Tox. 3; STOT RE 1
200-261-2
56-18-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
200-242-9
55-68-5
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
200-240-8
55-63-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
200-193-3
54-11-5
Acute Tox. 2
200-181-8
53-70-3
Carc. 1B
200-149-3
52-68-6
Acute Tox. 4; Skin Sens. 1
200-143-0
52-51-7
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-123-1
51-79-6
Carc. 1B
200-104-8
51-55-8
Acute Tox. 2
200-090-3
51-34-3
Acute Tox. 2; Acute Tox. 1
200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
200-026-4
50-31-7
Acute Tox. 4
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
200-014-9
50-14-6
Acute Tox. 2; Acute Tox. 3; STOT RE 1
200-002-3
50-01-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
200-001-8
50-00-0
Carc. 1B; Muta. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
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Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
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Carc. 1A; Acute Tox. 4; Skin Sens. 1
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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P Parasites
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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Dioxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 241-951-3 | CAS no: 18039-69-5
Uranyl acetate-2H2O EC / List no: 629-550-5 | CAS no: 6159-44-0
Uranium diboride EC / List no: 234-508-0 | CAS no: 12007-36-2
Bis(nitrato-O,O')dioxouranium EC / List no: 253-053-9 | CAS no: 36478-76-9
Bis(nitrato-O)dioxouranium EC / List no: 233-266-3 | CAS no: 10102-06-4
Bis(formato-O)dioxouranium EC / List no: 241-063-6 | CAS no: 16984-59-1
Resin acids and Rosin acids, uranyl salts EC / List no: 273-325-0 | CAS no: 68956-97-8
Uranium hexafluoride EC / List no: 232-028-6 | CAS no: 7783-81-5
Uranium tetraiodide EC / List no: 236-735-0 | CAS no: 13470-22-9
Sodium tris(benzeneacetato-O)dioxouranate(1-) EC / List no: 309-040-6 | CAS no: 99800-13-2
Uranium trifluoride EC / List no: 237-404-3 | CAS no: 13775-06-9
Uranium fluoride (U2F9) EC / List no: - | CAS no: 12134-48-4
Uranium diselenide EC / List no: 235-245-4 | CAS no: 12138-21-5
Uranium dioxide EC / List no: 215-700-3 | CAS no: 1344-57-6
Barium uranium oxide EC / List no: - | CAS no: 10380-31-1
Bis(2-ethylhexanoato-O)dioxouranium EC / List no: 267-849-9 | CAS no: 67939-77-9
polysilicate EC / List no: - | CAS no: 12427-14-4
Uranium nitride EC / List no: - | CAS no: 12058-37-6
Uranium tetrachloride EC / List no: 233-057-7 | CAS no: 10026-10-5
Sodium uranyl triacetate, of uranium depleted in uranium-235 EC / List no: 241-714-4 | CAS no: 17712-38-8
Difluorodioxouranium EC / List no: 236-898-8 | CAS no: 13536-84-0
Bis(acetato-O)dioxouranium EC / List no: 208-767-5 | CAS no: 541-09-3
Lead uranate pigment EC / List no: 287-565-9 | CAS no: 85536-79-4
Dipotassium heptaoxodiuranate EC / List no: 232-217-3 | CAS no: 7790-63-8
Uranium tetrafluoride EC / List no: 233-170-1 | CAS no: 10049-14-6
Acetic acid, uranium(4+) zinc salt EC / List no: 243-904-2 | CAS no: 20596-91-2
Calcium diuranium heptaoxide EC / List no: 237-428-4 | CAS no: 13780-21-7
Triuranium octaoxide EC / List no: 215-702-4 | CAS no: 1344-59-8
Nickel triuranium decaoxide EC / List no: 239-876-6 | CAS no: 15780-33-3
[oxalato(2-)-O,O']dioxouranium EC / List no: 217-986-5 | CAS no: 2031-89-2
Uranium tetraboride EC / List no: 234-520-6 | CAS no: 12007-84-0
Disodium uranium tetraoxide EC / List no: 236-846-4 | CAS no: 13510-99-1
Hydrogen dioxo[phosphato(3-)-O,O']uranate(1-) EC / List no: 242-306-9 | CAS no: 18433-48-2
Uranium ditelluride EC / List no: 235-249-6 | CAS no: 12138-37-3
Uranium dioxideperoxide EC / List no: 234-852-1 | CAS no: 12036-71-4
Magnesium diuranium heptaoxide EC / List no: 236-982-4 | CAS no: 13568-61-1
Uranium carbide (UC2) EC / List no: - | CAS no: 12071-33-9
Uranium tetrabromide EC / List no: 236-734-5 | CAS no: 13470-20-7
Tetrakis(pentane-2,4-dionato-O,O')uranium EC / List no: 265-498-6 | CAS no: 65137-03-3
Triuranium tetraphosphide EC / List no: 234-871-5 | CAS no: 12037-84-2
Uranium carbide (UC) EC / List no: - | CAS no: 12070-09-6
Uranium disulphide EC / List no: 234-884-6 | CAS no: 12039-14-4
Uranium disilicide EC / List no: 234-906-4 | CAS no: 12039-85-9
Uranium nitrate EC / List no: - | CAS no: 13826-82-9
Oxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 254-311-3 | CAS no: 39136-40-8
Calcines, uranium ore-conc.
Calcined precipitates of ammonium, magnesium or sodium uranates obtained from natural uranium ores.
EC / List no: 297-819-0 | CAS no: 93763-02-1
Dichlorodioxouranium EC / List no: 232-246-1 | CAS no: 7791-26-6
Magnesium uranium(4+) hexaacetate EC / List no: 243-905-8 | CAS no: 20596-93-4
Diammonium diuranium heptaoxide EC / List no: 231-986-2 | CAS no: 7783-22-4
Nitric acid, uranium(6+) salt EC / List no: - | CAS no: 20820-60-4
Nasturan EC / List no: 690-098-7 | CAS no: 1317-99-3
Uranium hydride EC / List no: 257-346-2 | CAS no: 51680-55-8
Uranium triiodide EC / List no: 237-406-4 | CAS no: 13775-18-3
Uranium pentafluoride EC / List no: 237-405-9 | CAS no: 13775-07-0
Disodium heptaoxodiuranate, of uranium depleted in uranium-235 EC / List no: 237-286-3 | CAS no: 13721-34-1
Nickel uranyl tetraacetate, of uranium depleted in uranium-235 EC / List no: 275-994-4 | CAS no: 71767-12-9
Zinc tetrakis(acetato-O)dioxouranate EC / List no: 251-762-8 | CAS no: 33959-50-1
Uranium trioxide EC / List no: 215-701-9 | CAS no: 1344-58-7
Dioxo[sulphato(2-)-O]uranium EC / List no: 215-240-3 | CAS no: 1314-64-3
Uranium hydride (UH3) EC / List no: - | CAS no: 13598-56-6
Tetraammonium uranyl tricarbonate, of uranium depleted in uranium-235 EC / List no: 241-988-5 | CAS no: 18077-77-5
Dipotassium uranyl bis(sulphate), of uranium depleted in uranium-235 EC / List no: 262-284-4 | CAS no: 60542-74-7
Titanate(4-), oxobis[phosphato(3-)]-, barium (1:2), uranium-doped EC / List no: 309-550-9 | CAS no: 100403-10-9
Nitric acid, uranium salt EC / List no: - | CAS no: 15905-86-9
Uranium EC / List no: 231-170-6 | CAS no: 7440-61-1
Zinc bis(acetato-O)dioxouranate EC / List no: 233-390-8 | CAS no: 10138-94-0
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Acute Tox. 2; STOT RE 2
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P Parasites
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P Parasites
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P Parasites
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P Parasites
-
138182-18-0
Repr. 2; STOT RE 2
-
7276-58-6
Acute Tox. 4
-
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Acute Tox. 3
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Acute Tox. 3
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
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74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
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Acute Tox. 2; Acute Tox. 1
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Acute Tox. 2; Acute Tox. 1
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P Parasites
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F Fungi
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F Fungi
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P Parasites
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Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
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26766-27-8
Acute Tox. 4
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Pyr. Liq. 1; Skin Corr. 1B
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
-
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P Parasites
-
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P Parasites
-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.

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