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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
212-634-7
834-12-8
Acute Tox. 4
MCPSI
410-900-9
83056-32-0
Flam. Liq. 3; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1
F5384
401-340-6
83055-99-6
Skin Sens. 1
JEFFCAT ZF-10; TEXACAT ZF-10
406-080-7
83016-70-0
Acute Tox. 4; Skin Corr. 1B

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