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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
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206-803-4
376-06-7
yes
218-165-4
2058-94-8
yes
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
yes
603-804-5
134237-52-8
yes
203-727-3
110-00-9
Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2
yes
200-842-0
75-12-7
Repr. 1B
yes
300-298-5
93925-00-9
yes
500-036-1
25214-70-4
yes
205-912-4
206-44-0
yes
292-966-7
91031-62-8
yes
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
yes
208-762-8
540-97-6
yes
215-540-4
1330-43-4
Repr. 1B
yes
601-808-1
12179-04-3
Repr. 1B
yes
603-411-9
1303-96-4
Repr. 1B
yes
234-541-0
12008-41-2
Repr. 1B
yes
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
235-702-8
12578-12-0
yes
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Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
799-973-9
-
yes
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
210-088-4
605-50-5
Repr. 1B
yes
276-090-2
71850-09-4
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
201-559-5
84-75-3
Repr. 1B
yes
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
236-881-5
13530-68-2
yes
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
201-557-4
84-74-2
Repr. 1B
yes
215-125-8
1303-86-2
Repr. 1B
yes
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
205-017-9
131-18-0
Repr. 1B
yes
950-299-5
-
yes
208-764-9
541-02-6
yes
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
215-607-8
1333-82-0
Ox. Sol. 1; Carc. 1A; Muta. 1B; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
yes
231-801-5
7738-94-5
yes

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