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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
421-830-3
49805-30-3
Acute Tox. 4; Skin Sens. 1
2-BUTYLOCTANEDIOIC ACID
431-210-4
50905-10-7
Eye Dam. 1
430-780-1
103146-25-4
Acute Tox. 4; Skin Sens. 1
430-790-6
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1

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