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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 listopada 2024. Database contains 4821 unique substances/entries.
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240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
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1065124-65-3
Acute Tox. 4; STOT SE 2
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
CIN 10096132; MTI
407-630-9
82633-79-2
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
255-853-3
42498-58-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
211-838-3
700-13-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
200-026-4
50-31-7
Acute Tox. 4
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
DCTFMP
410-340-5
69045-84-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
201-153-8
78-88-6
Flam. Liq. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1

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