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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 srpnja 2024. Database contains 4821 unique substances/entries.
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Carc. 1B; Acute Tox. 4
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Acute Tox. 4
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Acute Tox. 4
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2-tert-butyl-4,6-dinitrophenyl acetate EC / List no: 221-706-7 | CAS no: 3204-27-1
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Repr. 1B; Acute Tox. 2; Acute Tox. 3
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Dinoseb acetate EC / List no: 220-560-1 | CAS no: 2813-95-8
Binapacryl EC / List no: 207-612-9 | CAS no: 485-31-4
2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) EC / List no: 258-532-6 | CAS no: 53404-43-6
Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate EC / List no: 252-331-7 | CAS no: 35040-03-0
Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 | CAS no: 6365-83-9
2-sec-butyl-4,6-dinitrophenol, compound with 1-aminopropan-2-ol (1:1) EC / List no: 275-931-0 | CAS no: 71735-19-8
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Repr. 1B; Acute Tox. 3; Eye Irrit. 2
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Acute Tox. 3
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Acute Tox. 3
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
425-210-3
169939-84-8
Skin Sens. 1
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68583-35-7
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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B Bacteria and similar species
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B Bacteria and similar species
200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
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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.
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
618-004-1
87392-12-9
Skin Sens. 1
243-193-9
19622-19-6
Acute Tox. 4
249-013-5
28434-00-6
Acute Tox. 4
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2635-50-9
Acute Tox. 3
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
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953-17-3
Acute Tox. 3

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