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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 srpnja 2024. Database contains 4821 unique substances/entries.
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240-841-2
16812-54-7
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
240-815-0
16752-77-5
Acute Tox. 2
240-718-3
16672-87-0
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C
240-539-0
16484-77-8
Acute Tox. 4; Eye Dam. 1
240-408-8
16337-84-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
240-286-6
16118-49-3
Carc. 2; Repr. 1B; Acute Tox. 4
240-235-8
16083-14-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
240-221-1
16071-86-6
Carc. 1B
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
240-016-7
15879-93-3
Acute Tox. 4; Acute Tox. 3; STOT SE 3
239-974-9
15852-21-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-967-0
15851-52-2
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-946-6
15843-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-924-6
15825-70-4
Unst. Expl.
239-924-6
15825-70-4
Expl. 1.1
239-876-6
15780-33-3
Carc. 1A; STOT RE 1; Skin Sens. 1
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
239-732-2
15662-33-6
Acute Tox. 4
239-714-4
15646-96-5
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
239-646-5
15586-38-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
239-592-2
15545-48-9
Carc. 2; Repr. 2
239-309-2
15263-52-2
Acute Tox. 4
239-290-0
15245-44-0
yes
239-290-0
15245-44-0
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
239-290-0
15245-44-0
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
239-172-9
15120-21-5
yes
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
239-139-9
15087-24-8
yes
239-125-2
15060-62-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-086-1
14998-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
239-056-8
14977-61-8
Ox. Liq. 1; Carc. 1B; Muta. 1B; Skin Corr. 1A; Skin Sens. 1
238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
238-946-3
14874-78-3
Carc. 1A; STOT RE 1; Skin Sens. 1
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
238-766-5
14721-18-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-753-4
14708-14-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-596-1
14550-87-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-511-8
14507-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
238-426-6
14448-18-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-413-5
14437-17-3
Acute Tox. 4
238-278-2
14332-34-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
238-253-6
14312-40-4
yes

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