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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
-
-
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.
VULKANISATIONSBESCHLEUNIGER VP KA 9124
404-380-2
110799-28-5
Skin Sens. 1
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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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2163-79-3
Acute Tox. 4
213-589-6
991-42-4
Acute Tox. 4
932-998-7
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yes
938-618-6
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yes
-
-
yes
939-993-9
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yes
931-754-7
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yes
931-753-1
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yes
931-756-8
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yes
931-755-2
-
yes
500-024-6
9016-45-9
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
203-931-2
112-05-0
Skin Irrit. 2; Eye Irrit. 2
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
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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
-
60999-18-0
Acute Tox. 3; STOT RE 2
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
200-876-6
75-52-5
Flam. Liq. 3; Acute Tox. 4
233-272-6
10102-44-0
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
217-406-0
1836-75-5
Carc. 1B; Repr. 1B; Acute Tox. 4
201-188-9
79-24-3
Flam. Liq. 3; Acute Tox. 4
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
DABCO X-412
413-670-8
103969-79-5
Eye Irrit. 2; Skin Sens. 1
238-076-4
14216-75-2
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
231-714-2
7697-37-2
Ox. Liq. 3; Acute Tox. 3; Skin Corr. 1A
217-682-2
1929-82-4
Acute Tox. 4
200-193-3
54-11-5
Acute Tox. 2
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
240-235-8
16083-14-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-827-7
7757-95-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
218-744-1
2223-95-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
244-578-4
21784-78-1
Carc. 1A; STOT RE 1; Skin Sens. 1
233-263-7
10101-96-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
222-102-6
3349-08-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
237-138-8
13654-40-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
225-656-7
4995-91-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
300-093-0
93920-09-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
300-094-6
93920-10-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-469-7
85508-44-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
249-555-2
29317-63-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1

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