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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
691-719-4
1072957-71-1
Acute Tox. 3
205-736-8
149-30-4
Skin Sens. 1
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
202-855-7
100-47-0
Acute Tox. 4
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
431-600-4
112226-61-6
Skin Sens. 1
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
205-877-5
189-55-9
Carc. 1B; Muta. 2
205-916-6
207-08-9
Carc. 1B
yes
205-910-3
205-82-3
Carc. 1B
205-883-8
191-24-2
yes
205-892-7
192-97-2
Carc. 1B
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
-
-
Carc. 1B
HWL-158
432-590-4
243869-48-9
Eye Irrit. 2
210-834-9
624-18-0
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
201-898-9
89-32-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
200-753-7
71-43-2
Flam. Liq. 2; Carc. 1A; Muta. 1B; STOT RE 1; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2
202-860-4
100-52-7
Acute Tox. 4
205-911-9
205-99-2
Carc. 1B
200-280-6
56-55-3
Carc. 1B
yes
246-585-8
25057-89-0
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
605-769-1
17606-31-4
Acute Tox. 4
212-010-4
741-58-2
Acute Tox. 4
207-807-9
495-73-8
Acute Tox. 3; Acute Tox. 4
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
245-216-8
22781-23-3
Acute Tox. 3; Acute Tox. 2
223-297-0
3813-05-6
Eye Irrit. 2; Skin Irrit. 2
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
201-622-7
85-68-7
Repr. 1B
yes
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
244-214-4
21109-95-5
Acute Tox. 4
-
-
Acute Tox. 4
256-814-3
50864-67-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
233-788-1
10361-37-2
Acute Tox. 3; Acute Tox. 4
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
208-167-3
513-77-9
Acute Tox. 4
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1

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