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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 2024. Database contains 4821 unique substances/entries.
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626-360-4
15244-35-6
yes
622-370-8
1522-92-5
yes
621-345-9
2315-67-5
yes
621-341-7
2315-61-9
yes
620-440-2
12510-42-8
Carc. 1A
620-436-0
75736-33-3
Eye Irrit. 2
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
620-422-4
4097-36-3
Acute Tox. 3
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
620-410-9
4234-79-1
Acute Tox. 3; Acute Tox. 4
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
620-362-9
1918-18-9
Acute Tox. 4
620-359-2
8065-36-9
Acute Tox. 3
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
620-041-3
907204-31-3
Lact.
619-823-7
494793-67-8
Carc. 2
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
619-377-3
98886-44-3
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
619-290-0
97780-06-8
Eye Irrit. 2
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
619-000-2
94125-34-5
Acute Tox. 4
618-541-1
9036-19-5
yes
618-392-2
9004-70-0
Expl. 1.1
618-344-0
9002-93-1
yes
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
618-004-1
87392-12-9
Skin Sens. 1
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
617-485-5
76714-88-0
Acute Tox. 4
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
617-258-0
81777-89-1
Acute Tox. 4
617-243-9
81591-81-3
Acute Tox. 4
617-219-8
81334-34-1
Eye Irrit. 2
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A

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