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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 srpnja 2024. Database contains 4821 unique substances/entries.
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213-666-4
999-81-5
Acute Tox. 4
246-538-1
24934-91-6
Acute Tox. 1; Acute Tox. 2
233-162-8
10049-04-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
233-162-8
10049-04-4
Acute Tox. 3; Skin Corr. 1B
231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
216-920-2
1698-60-8
Skin Sens. 1
207-432-0
470-90-6
Acute Tox. 2; Acute Tox. 3
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
238-413-5
14437-17-3
Acute Tox. 4
201-246-3
80-06-8
Acute Tox. 4
602-782-4
122453-73-0
Acute Tox. 3; Acute Tox. 4
201-599-3
85-34-7
Acute Tox. 4
243-269-1
19750-95-9
Carc. 2; Acute Tox. 4
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
205-601-3
143-50-0
Carc. 2; Acute Tox. 3
200-349-0
57-74-9
Carc. 2; Acute Tox. 4
240-016-7
15879-93-3
Acute Tox. 4; Acute Tox. 3; STOT SE 3
206-117-5
302-17-0
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
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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.
618-392-2
9004-70-0
Expl. 1.1
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Resp. Sens. 1
232-734-4
9012-54-8
Resp. Sens. 1
253-465-9
37329-65-0
Resp. Sens. 1
202-759-5
99-49-0
Skin Sens. 1
239-309-2
15263-52-2
Acute Tox. 4
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B Bacteria and similar species
226-031-1
5234-68-4
STOT RE 2; Skin Sens. 1
259-565-9
55285-14-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
212-324-1
786-19-6
Acute Tox. 3
240-408-8
16337-84-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
200-262-8
56-23-5
Carc. 2; Acute Tox. 3; STOT RE 1
211-128-3
630-08-0
Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1
200-843-6
75-15-0
Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
216-353-0
1563-66-2
Acute Tox. 2
240-286-6
16118-49-3
Carc. 2; Repr. 1B; Acute Tox. 4
234-232-0
10605-21-7
Muta. 1B; Repr. 1B; Skin Sens. 1
200-555-0
63-25-2
Carc. 2; Acute Tox. 4
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
205-087-0
133-06-2
Carc. 2; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
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P Parasites
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P Parasites
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F Fungi
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F Fungi
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B Bacteria and similar species

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