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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 lipnja 2024. Database contains 4821 unique substances/entries.
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218-951-7
2300-66-5
Eye Irrit. 2
225-918-0
5146-66-7
Muta. 1B
259-978-4
56073-07-5
Repr. 1B; Acute Tox. 1; STOT RE 1
257-187-9
51414-25-6
Skin Sens. 1A
208-293-9
520-45-6
Acute Tox. 4
205-057-7
132-32-1
Carc. 1B
204-473-6
121-47-1
Acute Tox. 4
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
209-711-2
591-27-5
Acute Tox. 4
203-236-4
104-78-9
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-680-9
109-55-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
213-048-4
919-30-2
Acute Tox. 4; Skin Corr. 1B
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
209-251-2
563-47-3
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
203-582-6
108-43-0
Acute Tox. 4
203-457-6
107-05-1
Flam. Liq. 2; Carc. 2; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-580-5
108-41-8
Acute Tox. 4
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
213-923-0
1067-08-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-621-0
619-99-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-529-0
617-78-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
259-627-5
55406-53-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1
209-130-4
556-56-9
Flam. Liq. 2; Skin Corr. 1B
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
209-264-3
563-80-4
Flam. Liq. 2
209-660-6
589-81-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-643-3
589-34-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
202-481-4
96-14-0
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
215-925-7
1453-58-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Corr. 1; Eye Dam. 1
209-526-7
584-02-1
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-025-1
77-40-7
yes
209-321-2
569-61-9
Carc. 1B
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
209-218-2
561-41-1
yes
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
257-907-1
52427-13-1
yes

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