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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 29 svibnja 2024. Database contains 4821 unique substances/entries.
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200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B
209-745-8
592-13-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
206-348-1
329-71-5
Acute Tox. 3; STOT RE 2
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
202-461-5
95-87-4
Acute Tox. 3; Skin Corr. 1B
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
209-445-7
579-66-8
Acute Tox. 4
203-620-1
108-83-8
Flam. Liq. 3; STOT SE 3
209-357-9
573-56-8
Acute Tox. 3; STOT RE 2
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
209-400-1
576-26-1
Acute Tox. 3; Skin Corr. 1B
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
203-867-5
111-41-1
Repr. 1B; Skin Corr. 1B; Skin Sens. 1
203-961-6
112-34-5
Eye Irrit. 2
203-985-7
112-56-1
Flam. Liq. 3; Acute Tox. 3
203-988-3
112-59-4
Acute Tox. 4; Eye Dam. 1
203-906-6
111-77-3
Repr. 2
247-384-8
25973-55-1
yes
253-037-1
36437-37-3
yes
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
201-289-8
80-54-6
Repr. 1B
yes
203-052-4
102-77-2
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
222-598-4
3547-33-9
Eye Dam. 1
220-548-6
2807-30-9
Acute Tox. 4; Eye Irrit. 2
205-592-6
143-22-6
Eye Dam. 1
243-816-4
20427-84-3
yes
230-770-5
7311-27-5
yes
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
202-544-6
96-91-3
Acute Tox. 4
202-544-6
96-91-3
Expl. 1.1; Acute Tox. 4
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
203-541-2
108-00-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
200-860-9
75-31-0
Flam. Liq. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
223-346-6
3846-71-7
yes
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
203-933-3
112-07-2
Acute Tox. 4
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
204-502-2
121-87-9
Acute Tox. 4
201-956-3
89-98-5
Skin Corr. 1B
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 1
210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
202-433-2
95-57-8
Acute Tox. 4

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