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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 srpnja 2024. Database contains 4821 unique substances/entries.
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204-987-0
130-37-0
Eye Irrit. 2; Skin Irrit. 2
277-543-7
73581-79-0
Eye Irrit. 2; Skin Irrit. 2
219-634-6
2487-01-6
Acute Tox. 3; Acute Tox. 4
205-275-2
137-05-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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
221-106-5
3006-10-8
Skin Corr. 1; Eye Dam. 1
219-993-9
2595-54-2
Acute Tox. 3
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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.
246-831-4
25319-90-8
Acute Tox. 4
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
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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.
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P Parasites
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P Parasites
239-924-6
15825-70-4
Unst. Expl.
239-924-6
15825-70-4
Expl. 1.1
232-089-9
7785-87-7
STOT RE 2
215-202-6
1313-13-9
Acute Tox. 4
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
203-703-2
109-77-3
Acute Tox. 3
203-571-6
108-31-6
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
BLACK JR 578
419-230-1
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Skin Sens. 1
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
422-610-1
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Eye Dam. 1
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
231-104-6
7439-95-4
Water-react. 1; Pyr. Sol. 1
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
241-022-2
16949-65-8
Acute Tox. 3
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
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F Fungi
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F Fungi
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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.
203-576-3
108-38-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
247-722-4
26471-62-5
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
203-583-1
108-44-1
Acute Tox. 3; STOT RE 2
208-790-0
541-69-5
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-584-7
108-45-2
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
PRODUCT 5899
404-150-1
17092-80-7
Skin Irrit. 2
203-577-9
108-39-4
Acute Tox. 3; Skin Corr. 1B
202-987-5
101-90-6
Carc. 1B; Muta. 2; Acute Tox. 3; Acute Tox. 4; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
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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.

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