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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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200-002-3
50-01-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
209-731-1
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
258-872-5
53933-48-5
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 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
200-090-3
51-34-3
Acute Tox. 2; Acute Tox. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Sens. 1
-
5827-05-4
Acute Tox. 1; Acute Tox. 3
208-746-0
540-42-1
Flam. Liq. 3
-
51337-71-4
Acute Tox. 4
208-818-1
542-55-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
208-819-7
542-56-3
Flam. Liq. 2; Carc. 1B; Muta. 2; Acute Tox. 4
200-401-2
58-89-9
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Lact.
208-790-0
541-69-5
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
260-979-7
57837-19-1
Acute Tox. 4; Skin Sens. 1
A5546
402-050-2
59337-93-8
Skin Sens. 1
209-132-5
556-61-6
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
209-060-4
554-12-1
Flam. Liq. 2; Acute Tox. 4
BETA-METHOXYACRYLSÄURE METHYLESTER
412-900-4
5788-17-0
Skin Sens. 1
209-765-7
592-62-1
Carc. 1B; Repr. 1B
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
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
429-640-2
52870-46-9
Eye Irrit. 2
209-669-5
590-01-2
Flam. Liq. 3
257-447-1
51818-56-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
258-051-1
52625-25-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
209-046-8
553-71-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
209-160-8
557-19-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
257-970-5
52502-12-2
Carc. 1A; STOT RE 1; Skin Sens. 1
208-933-7
547-67-1
Carc. 1A; STOT RE 1; Skin Sens. 1
200-193-3
54-11-5
Acute Tox. 2
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
209-136-7
556-67-2
Repr. 2
yes
226-066-2
5259-88-1
Acute Tox. 4
200-397-2
58-74-2
Acute Tox. 4
200-271-7
56-38-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1
258-067-9
52645-53-1
Acute Tox. 4; Skin Sens. 1
-
57427-55-1
yes
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-242-9
55-68-5
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
-
5826-76-6
Acute Tox. 4
200-332-8
57-47-6
Acute Tox. 2
209-676-3
590-28-3
Acute Tox. 4
-
5787-96-2
Acute Tox. 3; STOT RE 2
PROSULFOCARB
401-730-6
52888-80-9
Acute Tox. 4; Skin Sens. 1
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1

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