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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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246-831-4
25319-90-8
Acute Tox. 4
219-993-9
2595-54-2
Acute Tox. 3
219-634-6
2487-01-6
Acute Tox. 3; Acute Tox. 4
217-991-2
2032-65-7
Acute Tox. 3
248-704-9
27871-49-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
220-815-7
2905-69-3
Acute Tox. 4; STOT SE 3
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
244-209-7
21087-64-9
Acute Tox. 4
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
429-570-2
213990-58-0
Skin Sens. 1
-
29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
248-505-7
27519-02-4
Skin Sens. 1B
435-860-1
214417-91-1
Skin Sens. 1
435-010-8
26157-73-3
Muta. 2
435-470-1
27366-72-9
Repr. 1B
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
-
2810-74-4
Acute Tox. 4
220-623-3
2836-04-6
Acute Tox. 3
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
429-120-5
208535-04-0
Eye Dam. 1
220-250-6
2687-91-4
Repr. 1B
437-720-3
227085-51-0
Eye Dam. 1
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
424-460-0
283167-56-6
Acute Tox. 4; Skin Sens. 1
218-130-3
2051-79-8
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
248-169-1
27016-75-7
Carc. 1A; STOT RE 1; Skin Sens. 1
247-430-7
26043-11-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
248-585-3
27637-46-3
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
244-578-4
21784-78-1
Carc. 1A; STOT RE 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
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
-
2163-79-3
Acute Tox. 4
218-276-8
2104-64-5
Acute Tox. 1; Acute Tox. 2
247-761-7
26530-20-1
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
244-058-7
20816-12-0
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
243-867-2
20543-06-0
Carc. 1A; STOT RE 1; Skin Sens. 1
245-445-3
23135-22-0
Acute Tox. 2; Acute Tox. 4
219-679-1
2497-07-6
Acute Tox. 2; Acute Tox. 3
247-770-6
26543-97-5
yes
218-196-3
2074-50-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
206-050-1
298-00-0
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; STOT RE 2
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
218-892-7
2275-14-1
Acute Tox. 3
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes

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