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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 07 listopada 2024. Database contains 4821 unique substances/entries.
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293-767-8
91082-53-0
Carc. 1B; Muta. 1B
271-020-7
68513-87-1
Carc. 1B; Muta. 1B
The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
266-016-7
65996-82-9
Carc. 1B; Muta. 1B
Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
266-024-0
65996-89-6
Carc. 1A
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
266-025-6
65996-90-9
Carc. 1A
The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
293-764-1
91082-50-7
Carc. 1B
The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.
232-361-7
8007-45-2
Carc. 1A
200-927-2
76-03-9
Skin Corr. 1A
211-479-2
650-51-1
STOT SE 3
251-793-7
34014-18-1
Acute Tox. 4
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
251-637-8
33693-04-8
Acute Tox. 4
227-637-9
5915-41-3
Acute Tox. 4; STOT RE 2
262-967-7
61788-32-7
yes
262-967-7
61788-32-7
yes
208-760-7
540-88-5
Flam. Liq. 2
216-768-7
1663-39-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
212-105-0
762-75-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-915-7
75-91-2
Muta. 2
216-653-1
1634-04-4
Flam. Liq. 2; Skin Irrit. 2
208-757-0
540-80-7
Flam. Liq. 2; Acute Tox. 4
222-389-8
3457-61-2
Org. Perox. E; Skin Irrit. 2
235-541-3
12267-73-1
Repr. 1B
yes
236-669-2
13463-39-3
Flam. Liq. 2; Carc. 2; Repr. 1B; Acute Tox. 2
204-274-4
118-75-2
Eye Irrit. 2; Skin Irrit. 2
204-825-9
127-18-4
Carc. 2
204-171-4
117-08-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
215-582-3
1333-22-8
Acute Tox. 4
215-910-5
1449-55-4
Acute Tox. 4
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-075-4
78-00-2
yes
204-126-9
116-14-3
Carc. 1B
230-625-6
7226-23-5
Repr. 2; Acute Tox. 4; Eye Dam. 1
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
251-823-9
34090-76-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-726-8
109-99-9
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
234-290-7
11070-44-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-728-9
110-01-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-783-1
126-33-0
Acute Tox. 4
235-380-9
12202-17-4
yes
231-711-6
7696-12-0
Carc. 2; Acute Tox. 4; STOT SE 2
213-979-6
1070-70-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
215-245-0
1314-85-8
Flam. Sol. 2; Water-react. 1; Acute Tox. 4

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