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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 2024. Database contains 4821 unique substances/entries.
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231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
-
-
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
-
-
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
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
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
218-953-8
2302-17-2
Skin Sens. 1
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
215-185-5
1310-73-2
Skin Corr. 1A
231-548-0
7631-90-5
Acute Tox. 4
231-665-7
7681-38-1
Eye Dam. 1
231-587-3
7646-69-7
Water-react. 1
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
616-541-6
7789-12-0
yes
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes

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