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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
215-202-6
1313-13-9
Acute Tox. 4
232-089-9
7785-87-7
STOT RE 2
239-924-6
15825-70-4
Unst. Expl.
239-924-6
15825-70-4
Expl. 1.1
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P Parasites
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P Parasites
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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.
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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.
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
246-831-4
25319-90-8
Acute Tox. 4
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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.
219-993-9
2595-54-2
Acute Tox. 3
221-106-5
3006-10-8
Skin Corr. 1; Eye Dam. 1
240-539-0
16484-77-8
Acute Tox. 4; Eye Dam. 1
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mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid EC / List no: 240-539-0 | CAS no: 16484-77-8
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Acute Tox. 4; Eye Dam. 1
205-275-2
137-05-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
219-634-6
2487-01-6
Acute Tox. 3; Acute Tox. 4
277-543-7
73581-79-0
Eye Irrit. 2; Skin Irrit. 2
204-987-0
130-37-0
Eye Irrit. 2; Skin Irrit. 2
201-123-4
78-57-9
Acute Tox. 4
432-140-7
110235-47-7
Carc. 2
213-447-3
950-10-7
Acute Tox. 1; Acute Tox. 2
205-769-8
150-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
217-991-2
2032-65-7
Acute Tox. 3
231-106-7
7439-97-6
Repr. 1B; Acute Tox. 2; STOT RE 1
231-299-8
7487-94-7
Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1; Skin Corr. 1B
211-057-8
628-86-4
Unst. Expl.; Acute Tox. 3; STOT RE 2
211-057-8
628-86-4
Expl. 1.1; Acute Tox. 3; STOT RE 2
203-604-4
108-67-8
Flam. Liq. 3; STOT SE 3
600-533-4
104206-82-8
Repr. 2; STOT RE 2
604-167-6
139968-49-3
Repr. 2; Lact.; STOT RE 2
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
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Acute Tox. 4
260-979-7
57837-19-1
Acute Tox. 4; Skin Sens. 1
615-135-6
70630-17-0
Acute Tox. 4; Eye Dam. 1
205-293-0
137-42-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
255-349-3
41394-05-2
Acute Tox. 4
266-583-0
67129-08-2
Skin Sens. 1B; Carc. 2
603-031-3
125116-23-6
Repr. 2; Acute Tox. 4
630-448-8
62610-77-9
Acute Tox. 4; Skin Sens. 1
201-204-4
79-41-4
Acute Tox. 4; Skin Corr. 1A
204-817-5
126-98-7
Flam. Liq. 2; Acute Tox. 3; Skin Sens. 1
233-606-0
10265-92-6
Acute Tox. 2; Acute Tox. 3
200-812-7
74-82-8
Flam. Gas 1; Press. Gas
200-898-6
75-75-2
Skin Corr. 1B
200-822-1
74-93-1
Flam. Gas 1; Press. Gas; Acute Tox. 3
200-659-6
67-56-1
Flam. Liq. 2; Acute Tox. 3; STOT SE 1
202-905-8
100-97-0
Flam. Sol. 2; Skin Sens. 1

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