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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 2024. Database contains 4821 unique substances/entries.
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215-993-8
1468-37-7
Acute Tox. 4
205-042-5
131-89-5
Acute Tox. 3
234-494-6
12007-01-1
Carc. 1A; STOT RE 1; Skin Sens. 1
238-426-6
14448-18-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-946-3
14874-78-3
Carc. 1A; STOT RE 1; Skin Sens. 1
237-411-1
13775-54-7
Carc. 1A; STOT RE 1; Skin Sens. 1
234-828-0
12035-64-2
Carc. 1A; STOT RE 1; Skin Sens. 1
235-033-1
12059-14-2
Carc. 1A; STOT RE 1; Skin Sens. 1
215-217-8
1314-06-3
Carc. 1A; STOT RE 1; Skin Sens. 1
246-673-6
25154-54-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
234-126-4
10544-72-6
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
247-096-2
25550-58-7
Acute Tox. 3; STOT RE 2
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
213-546-1
973-21-7
Acute Tox. 3
254-408-0
39300-45-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes
215-813-8
1420-07-1
Repr. 1B; Acute Tox. 2; Acute Tox. 3
293-901-5
91648-39-4
Repr. 1B; STOT RE 1
222-883-3
3648-18-8
Repr. 1B; STOT RE 1
223-292-3
3811-49-2
Acute Tox. 3; STOT SE 1
230-253-4
6988-21-2
Acute Tox. 3
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
235-702-8
12578-12-0
yes
201-434-5
82-66-6
Acute Tox. 2; STOT RE 1
213-482-4
957-51-7
Acute Tox. 4
251-084-2
32534-81-9
STOT RE 2; Lact.
278-355-8
75980-60-8
Repr. 2
204-539-4
122-39-4
Acute Tox. 3; STOT RE 2
251-087-9
32536-52-0
Repr. 1B
215-242-4
1314-80-3
Flam. Sol. 1; Water-react. 1; Acute Tox. 4
220-639-0
2844-92-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
240-979-3
16921-30-5
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
215-197-0
1312-73-8
Skin Corr. 1B
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-869-6
111-43-3
Flam. Liq. 2; STOT SE 3
205-565-9
142-84-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
223-714-6
4032-26-2
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
240-983-5
16923-58-3
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
234-541-0
12008-41-2
Repr. 1B
yes
215-211-5
1313-82-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
215-540-4
1330-43-4
Repr. 1B
yes
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
240-221-1
16071-86-6
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons.
295-304-5
91995-42-5
Carc. 1B

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