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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 30 September 2022. Database contains 4821 unique substances/entries.
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205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
430-730-9
-
Eye Dam. 1
T001446
419-600-2
99199-90-3
Skin Sens. 1
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
BRL 44742
415-550-0
109887-53-8
Acute Tox. 4; Eye Dam. 1
T001769
419-290-9
780757-44-0
Skin Sens. 1
CG 24-020; FERROCEN-SBF6
407-840-0
100011-37-8
Acute Tox. 4; Eye Dam. 1
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
204-528-4
122-20-3
Eye Irrit. 2
COMPIMIDE™ 121
405-840-5
110866-35-8
Skin Sens. 1
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
203-820-9
110-97-4
Eye Irrit. 2
430-250-1
406-58-6
Flam. Liq. 2
200-756-3
71-55-6
Acute Tox. 4
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
D 28-283
419-430-9
56533-00-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
424-980-8
22288-41-1
Flam. Liq. 2; Org. Perox. D; Skin Irrit. 2; Skin Sens. 1
209-854-0
594-72-9
Acute Tox. 3
200-863-5
75-34-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
200-864-0
75-35-4
Flam. Liq. 1; Carc. 2; Acute Tox. 4
209-253-3
563-58-6
Flam. Liq. 2; Acute Tox. 3
203-310-6
105-57-7
Flam. Liq. 2; Eye Irrit. 2; Skin Irrit. 2
413-740-8
1132-95-2
Skin Corr. 1B
208-589-8
534-15-6
Flam. Liq. 2
-
4482-55-7
Skin Irrit. 2
442-850-9
114772-40-6
Skin Sens. 1
246-147-6
24307-26-4
Acute Tox. 4
LUPEROX 570
431-610-9
68860-54-8
Org. Perox. D; Skin Sens. 1
200-629-2
66-71-7
Acute Tox. 3
210-168-9
608-73-1
Carc. 2; Acute Tox. 3; Acute Tox. 4
212-230-0
771-29-9
Org. Perox. D; Acute Tox. 4; Skin Corr. 1B
RO 1173
414-270-6
41959-35-7
Acute Tox. 4
204-340-2
119-64-2
Eye Irrit. 2; Skin Irrit. 2
-
6202-15-9
Expl. 1.1; Acute Tox. 4
212-557-9
826-62-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
226-247-6
5333-84-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
206-022-9
288-88-0
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
204-428-0
120-82-1
Acute Tox. 4; Skin Irrit. 2
202-436-9
95-63-6
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
221-695-9
3194-55-6
Repr. 2; Lact.
yes
271-094-0
68515-51-5
yes
271-093-5
68515-50-4
Repr. 1B
yes

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