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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 29 svibnja 2024. Database contains 4821 unique substances/entries.
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201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
219-989-7
2592-95-2
Expl. 1.3
204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
202-796-7
99-87-6
Flam. Liq. 3; Acute Tox. 3; Asp. Tox. 1
203-539-1
107-98-2
Flam. Liq. 3; STOT SE 3
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
210-946-8
626-38-0
Flam. Liq. 3
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
205-138-7
134-32-7
Acute Tox. 4
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
202-155-1
92-43-3
Acute Tox. 4
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
214-012-0
1072-63-5
Repr. 1B
yes
282-263-3
84145-37-9
Flam. Liq. 3
203-872-2
111-46-6
Acute Tox. 4
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-312-7
105-59-9
Eye Irrit. 2
214-237-4
1116-54-7
Carc. 1B
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
200-733-8
70-30-4
Acute Tox. 3
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-874-3
111-48-8
Eye Irrit. 2
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
207-346-3
464-06-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-266-4
564-02-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
208-759-1
540-84-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
yes
233-539-7
10222-01-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-689-4
590-73-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-680-5
590-35-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
253-057-0
36483-57-5
yes
207-343-7
463-82-1
Flam. Gas 1; Press. Gas
218-741-5
2223-82-7
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
236-236-8
13252-13-6
yes

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