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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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252-615-0
35554-44-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Dam. 1
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
252-139-3
34681-10-2
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2
251-899-3
34256-82-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT SE 3; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
251-835-4
34123-59-6
Carc. 2; STOT RE 2
251-823-9
34090-76-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
251-793-7
34014-18-1
Acute Tox. 4
251-684-4
33813-20-6
Acute Tox. 4
251-637-8
33693-04-8
Acute Tox. 4
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
251-087-9
32536-52-0
Repr. 1B
251-084-2
32534-81-9
STOT RE 2; Lact.
250-863-4
31906-04-4
Skin Sens. 1A
250-859-2
31895-22-4
Acute Tox. 4
250-788-7
31748-25-1
Carc. 1A; STOT RE 1; Skin Sens. 1
250-778-2
31717-87-0
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
250-610-8
31394-54-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
250-517-2
31218-83-4
Acute Tox. 3
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
250-366-2
30864-28-9
Acute Tox. 4; Skin Sens. 1
250-339-5
30784-30-6
yes
250-241-2
30560-19-1
Acute Tox. 4
250-010-6
30043-49-3
Skin Sens. 1
249-981-9
29973-13-5
Acute Tox. 4
249-707-8
29590-42-9
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
249-644-6
29457-72-5
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
249-555-2
29317-63-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
249-205-9
28772-56-7
Repr. 1B; Acute Tox. 1; STOT RE 1
249-013-5
28434-00-6
Acute Tox. 4
248-924-5
28249-77-6
Acute Tox. 4
248-743-1
27942-27-4
yes
248-704-9
27871-49-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
248-585-3
27637-46-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
248-523-5
27554-26-3
Repr. 1B
248-505-7
27519-02-4
Skin Sens. 1B
248-259-0
27140-08-5
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
248-169-1
27016-75-7
Carc. 1A; STOT RE 1; Skin Sens. 1
247-861-0
26635-64-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
247-852-1
26628-22-8
Acute Tox. 2
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
247-816-5
26571-11-9
yes
247-770-6
26543-97-5
yes
247-761-7
26530-20-1
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
247-759-6
26523-78-4
Skin Sens. 1
yes
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
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
247-656-6
26399-36-0
Eye Irrit. 2

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