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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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230-253-4
6988-21-2
Acute Tox. 3
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
229-851-8
6786-83-0
yes
229-352-5
6485-40-1
Skin Sens. 1
229-335-2
6477-64-1
yes
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
228-652-3
6317-18-6
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
227-678-2
5932-68-3
Skin Sens. 1A
227-637-9
5915-41-3
Acute Tox. 4; STOT RE 2
227-633-7
5912-86-7
Skin Sens. 1A
227-534-9
5873-54-1
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
227-419-3
5834-96-8
Acute Tox. 4
227-317-9
5786-97-0
Acute Tox. 2
227-197-8
5707-69-7
Acute Tox. 3
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
227-011-5
5598-13-0
Skin Sens. 1
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
226-907-3
5543-57-7
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
226-798-2
5470-11-1
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
226-247-6
5333-84-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2
226-066-2
5259-88-1
Acute Tox. 4
226-031-1
5234-68-4
STOT RE 2; Skin Sens. 1
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
225-918-0
5146-66-7
Muta. 1B
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
225-875-8
5131-24-8
Skin Irrit. 2; Skin Sens. 1
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
225-656-7
4995-91-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
225-432-9
4845-99-2
Acute Tox. 2
225-399-0
4824-78-6
Acute Tox. 3; Acute Tox. 4
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
224-729-0
4464-23-7
Acute Tox. 3; Carc. 2; STOT RE 2
224-699-9
4454-16-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
224-580-1
4418-26-2
Acute Tox. 4
224-168-1
4221-99-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3

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